Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy

January 31, 2023 updated by: Jiaxing Tian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
This study is a randomized, positive drug parallel-controlled clinical trial in participants with diabetic gastroenteropathy. A total of 60 participants will be recruited for the study, all of whom are diagnosed as diabetes mellitus combined with gastroenteropathy. The subjects will be divided randomly into two groups and treated with either Tangweian Recipe+mosapride citrate tablets or mosapride citrate tablets for four weeks. The primary outcome will be the change in gastroparesis symptom severity, as measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Daily diary Index-Daily Diary (ANMS GCSI-DD). And participants will be seen for a clinic evaluation at weeks 0 and 4, during which symptom scores, adverse events and treatment compliance will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 (Anticipated)

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.
60

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.
  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18 to 70 years at the time of their consent;
  2. Those diagnosed with diabetic gastrointestinal lesions with gastrointestinal symptoms such as nausea/vomiting, early satiety, bloating, and epigastric pain for more than 3 months or longer;
  3. History of symptoms of mellitus for at least 5 years leading up to the Screening Visit and Blood glucose stable within 1 month;
  4. Mean Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (GEBT);
  5. TCM Syndrome differentiation as spleen deficiency and stomach stagnation syndrome;
  6. Signed informed consent.

Exclusion Criteria:

  1. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month;
  2. Patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with GLP-1 class drugs;
  3. Have a history of or are suffering from severe gastrointestinal disease
  4. Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year;
  5. Combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence;
  6. Women who are pregnant, preparing for pregnancy or breastfeeding;
  7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies;
  8. According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.

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: PARALLEL
  • Masking: NONE

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: Tangweian Recipe Group
  1. Tangweian formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals.
  2. 1 mosapride citratetablet per time, 3 times a day, take it with meals.
Drug: Tangweian Recipe
The Tangweian recipe is a combination of several Chinese herbs
Drug: Mosapride Citrate
The mosapride citrate tablets will be administrated.
ACTIVE_COMPARATOR: Mosapride Citrate Group
1 mosapride citratetablet per time, 3 times a day, take it with meals.
Drug: Mosapride Citrate
The mosapride citrate tablets will be administrated.

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
Sub-scores of the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
Time Frame: Baseline to Week 4
Change from Baseline at weeks 0 through 4 as measured by patient's daily diary entries during participation in the study.
Baseline to Week 4
Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)
Time Frame: 0 week, 4 weeks
0 week, 4 weeks

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
Time Frame
Changes from Baseline Fasting Blood Glucose at 4 weeks
Time Frame: 0 week, 4 weeks
0 week, 4 weeks
Changes from Baseline Body Mass Index at 4 weeks
Time Frame: 0 week, 4 weeks
0 week, 4 weeks
Change from Baseline TCM Symptom Score at 4 weeks
Time Frame: 0 week, 4 weeks
0 week, 4 weeks
SF-36 Health Survey Questionnaire
Time Frame: 0 week, 4 weeks
0 week, 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: 0 week, 4 weeks
0 week, 4 weeks

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.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 (ANTICIPATED)

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 1, 2023

Primary Completion (ANTICIPATED)

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.
January 31, 2025

Study Completion (ANTICIPATED)

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.
January 1, 2026

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).
January 31, 2023

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.
January 31, 2023

First Posted (ESTIMATE)

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.
February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

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.
February 9, 2023

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.
January 31, 2023

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.
January 1, 2023

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.
  • SFIMD2022B06

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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