Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

November 22, 2019 updated by: Johns Hopkins University
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No any systemic diseases;
  • no scleroderma; no history of gastrointestinal surgery;
  • no dyspeptic symptoms during the past 2 weeks;
  • not taking any medications except contraceptives during the past 2 weeks;
  • age 18 and older.

Exclusion Criteria:

  • History of any systemic diseases or surgeries;
  • allergic to adhesives; pregnancy;
  • unable to sign the consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: scleroderma patients-0
for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
Device: transcutaneous electroacupuncture
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Other Names:
  • TEA
Experimental: scleroderma patient-1
for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Device: transcutaneous electroacupuncture
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Other Names:
  • TEA
Experimental: scleroderma patients-2
for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Device: transcutaneous electroacupuncture
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Other Names:
  • TEA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 1 day
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 28 days
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 42 days
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 70 days
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 1 day
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 28 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 42 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 70 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 1 day
SF-36 questionnaire will be used to assess general quality of life
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 28 days
SF-36 questionnaire will be used to assess general quality of life
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 42 days
SF-36 questionnaire will be used to assess general quality of life
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 70 days
SF-36 questionnaire will be used to assess general quality of life
70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 1 day
a validated method including 9 symptoms will be used to assess GI symptoms
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 28 days
a validated method including 9 symptoms will be used to assess GI symptoms
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 42 days
a validated method including 9 symptoms will be used to assess GI symptoms
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time Frame: 70 days
a validated method including 9 symptoms will be used to assess GI symptoms
70 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
effects of TEA on gastric motility
Time Frame: 1 week
visit 1 in acute phase; gastric slow waves recording
1 week
effects of TEA on gastric motility
Time Frame: 2 weeks
visit 2 in acute phase; gastric slow waves recording
2 weeks
effects of TEA on gastric motility
Time Frame: 3 weeks
visit 3 in acute phase; gastric slow waves recording
3 weeks
effects of TEA on gastric motility
Time Frame: 4 weeks
visit 4 in acute phase; gastric slow waves recording
4 weeks
effects of TEA on autonomic function
Time Frame: 1 week
visit 1 in acute phase; heart rate variability recording
1 week
effects of TEA on autonomic function
Time Frame: 2 weeks
visit 2 in acute phase; heart rate variability recording
2 weeks
effects of TEA on autonomic function
Time Frame: 3 weeks
visit 3 in acute phase; heart rate variability recording
3 weeks
effects of TEA on autonomic function
Time Frame: 4 weeks
visit 4 in acute phase; heart rate variability recording
4 weeks
effects of TEA on gastric motility
Time Frame: 1 day
visit 1 in chronic phase; gastric slow waves recording
1 day
effects of TEA on gastric motility
Time Frame: 28 days
visit 2 in chronic phase; gastric slow waves recording
28 days
effects of TEA on gastric motility
Time Frame: 42 days
visit 3 in chronic phase; gastric slow waves recording
42 days
effects of TEA on gastric motility
Time Frame: 70 days
visit 4 in chronic phase; gastric slow waves recording
70 days
effects of TEA on gastric motility
Time Frame: 1 day
visit 1 in chronic phase; breath test will be used to assess gastric emptying
1 day
effects of TEA on gastric motility
Time Frame: 28 days
visit 2 in chronic phase; breath test will be used to assess gastric emptying
28 days
effects of TEA on gastric motility
Time Frame: 42 days
visit 3 in chronic phase; breath test will be used to assess gastric emptying
42 days
effects of TEA on gastric motility
Time Frame: 70 days
visit 4 in chronic phase; breath test will be used to assess gastric emptying
70 days
effects of TEA on autonomic function
Time Frame: 1 day
visit 1 in chronic phase; heart rate variability recording
1 day
effects of TEA on autonomic function
Time Frame: 28 days
visit 2 in chronic phase; heart rate variability recording
28 days
effects of TEA on autonomic function
Time Frame: 42 days
visit 3 in chronic phase; heart rate variability recording
42 days
effects of TEA on autonomic function
Time Frame: 70 days
visit 4 in chronic phase; heart rate variability recording
70 days
effects of TEA on autonomic function
Time Frame: 1 day
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
1 day
effects of TEA on autonomic function
Time Frame: 28 days
visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
28 days
effects of TEA on autonomic function
Time Frame: 42 days
visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
42 days
effects of TEA on autonomic function
Time Frame: 70 days
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function
70 days
effects of TEA on autonomic function
Time Frame: 1 day
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
1 day
effects of TEA on autonomic function
Time Frame: 28 days
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
28 days
effects of TEA on autonomic function
Time Frame: 42 days
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
42 days
effects of TEA on autonomic function
Time Frame: 70 days
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
70 days
effects of TEA on autonomic function
Time Frame: 1 day
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
1 day
effects of TEA on autonomic function
Time Frame: 28 days
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
28 days
effects of TEA on autonomic function
Time Frame: 42 days
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
42 days
effects of TEA on autonomic function
Time Frame: 70 days
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
70 days
effects of TEA on autonomic function
Time Frame: 1 day
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
1 day
effects of TEA on autonomic function
Time Frame: 28 days
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
28 days
effects of TEA on autonomic function
Time Frame: 42 days
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
42 days
effects of TEA on autonomic function
Time Frame: 70 days
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
70 days
effects of TEA on autonomic function
Time Frame: 1 day
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
1 day
effects of TEA on autonomic function
Time Frame: 28 days
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
28 days
effects of TEA on autonomic function
Time Frame: 42 days
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
42 days
effects of TEA on autonomic function
Time Frame: 70 days
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
70 days
effects of TEA on autonomic function
Time Frame: 1 day
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
1 day
effects of TEA on autonomic function
Time Frame: 28 days
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
28 days
effects of TEA on autonomic function
Time Frame: 42 days
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
42 days
effects of TEA on autonomic function
Time Frame: 70 days
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
70 days
effects of TEA on autonomic function
Time Frame: 1 day
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
1 day
effects of TEA on autonomic function
Time Frame: 28 days
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
28 days
effects of TEA on autonomic function
Time Frame: 42 days
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
42 days
effects of TEA on autonomic function
Time Frame: 70 days
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
baseline before the study; vasoactive intestinal peptide (VIP)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
baseline before the study; vasoactive intestinal peptide (VIP)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
baseline before the study; vasoactive intestinal peptide (VIP)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
baseline before the study; vasoactive intestinal peptide (VIP)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: day 1
baseline before the study; interleukin-10 (IL-10)
day 1
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
baseline before the study; interleukin-10 (IL-10)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
baseline before the study; interleukin-10 (IL-10)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
baseline before the study; interleukin-10 (IL-10)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
30 minutes after the testing meal; interleukin-10 (IL-10)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
30 minutes after the testing meal; interleukin-10 (IL-10)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
30 minutes after the testing meal; interleukin-10 (IL-10)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
30 minutes after the testing meal; interleukin-10 (IL-10)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
60 minutes after the testing meal; interleukin-10 (IL-10)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
60 minutes after the testing meal; interleukin-10 (IL-10)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
60 minutes after the testing meal; interleukin-10 (IL-10)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
60 minutes after the testing meal; interleukin-10 (IL-10)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
baseline before the study; interferon α(IFNα)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
baseline before the study; interferon α(IFNα)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
baseline before the study; interferon α(IFNα)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
baseline before the study; interferon α(IFNα)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
30 minutes after the testing meal; interferon α(IFNα)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
30 minutes after the testing meal; interferon α(IFNα)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
30 minutes after the testing meal; interferon α(IFNα)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
30 minutes after the testing meal; interferon α(IFNα)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
60 minutes after the testing meal; interferon α(IFNα)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
60 minutes after the testing meal; interferon α(IFNα)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
60 minutes after the testing meal; interferon α(IFNα)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
60 minutes after the testing meal; interferon α(IFNα)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
baseline before the study; interleukin-1 beta (IL-1β)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
baseline before the study; interleukin-1 beta (IL-1β)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
baseline before the study; interleukin-1 beta (IL-1β)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
baseline before the study; interleukin-1 beta (IL-1β)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
baseline before the study; interleukin-6 (IL-6)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
baseline before the study; interleukin-6 (IL-6)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
baseline before the study; interleukin-6 (IL-6)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
baseline before the study; interleukin-6 (IL-6)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
30 minutes after the testing meal; interleukin-6 (IL-6)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
30 minutes after the testing meal; interleukin-6 (IL-6)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
30 minutes after the testing meal; interleukin-6 (IL-6)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
30 minutes after the testing meal; interleukin-6 (IL-6)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
60 minutes after the testing meal; interleukin-6 (IL-6)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
60 minutes after the testing meal; interleukin-6 (IL-6)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
60 minutes after the testing meal; interleukin-6 (IL-6)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
60 minutes after the testing meal; interleukin-6 (IL-6)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: day 1
baseline before the study; tumor necrosis factor alpha(TNFα)
day 1
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
baseline before the study; tumor necrosis factor alpha(TNFα)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
baseline before the study; tumor necrosis factor alpha(TNFα)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
baseline before the study; tumor necrosis factor alpha(TNFα)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
70 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 1 day
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
1 day
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 28 days
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
28 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 42 days
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
42 days
effects of TEA on GI hormones and inflammatory cytokine
Time Frame: 70 days
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
70 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiande Chen, Ph.D, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00089514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

haven't decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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