Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick

October 18, 2023 updated by: Bui Pham Minh Man

Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick: A Pilot Study

Moxibustion plays an important role in Traditional Medicine treatments, which treats and prevents diseases by burning a herb preparation containing Moxa (Artemisia vulgaris, Mugwort) to stimulate the meridians of human body. Moxibustion is considered a safe and effective traditional therapy. Mild moxibustion is a kind of therapeutic method which characterized by wide indications, simple manipulation and comfortable feeling, is commonly used in clinical treatment. Mingmen acupoint located on the midline of the lower back, in the depression below the spinous process of the 2nd lumbar vertebra (L2). Its indications include Yang-deficiency syndrome, Cold-Stagnation syndrome, Cold Excessive syndrome,... and it is closely related to the knee area through the path of Thoroughfare Vessel (one of the Eight Extraordinary Vessels). In our study, we investigate the change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint with moxa stick in healthy volunteers.

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.

Detailed Description

Participants and Methods: A randomized controlled trial is conducted by comparing the change in skin surface temperature before and after using mild moxibustion manipulation at the research acupoint (Mingmen (GV-4) acupoint) or the control acupoint (the left side Pishu (BL-20) acupoint) in healthy volunteers. A total of 38 participants will undergo 2 trial phases, corresponding to 2 times of moxibustion in 8 days, each time is 7 days apart. In the first trial phase: participants received moxibustion at left side Pishu (BL-20) acupoint. In the second trial phase: participants received moxibustion at Mingmen (GV-4) acupoint. The primary outcome was the change in skin surface temperature at the local stimulated area and the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint. This trial will be performed as a pilot study.

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.
38

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 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.
  • Name: Minh-Man Pham Bui, Medical doctor
  • Phone Number: +84916080803
  • Email: bpmman@ump.edu.vn

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy males and females were individual age between enough 18 and 30 years old.
  • BMI: 18.5 - 23 kg/m2
  • Mental alertness, good contact, cooperation with researchers.
  • Had no psychiatric stress problem during moxibustion day (confirmed by answering the DASS 21 questionaire with stress point less than 15 points).
  • Had no history of cardio-vascular disease, diabetes, hyperthyroidism, hypothyroidism.

  • Vital sign within normal limits:

    • Heart rates from from 60 to 99 beats/minute.
    • Systolic blood pressure between 90 and 139 mmHg.
    • Diastolic blood pressure between 60 and 89 mmHg.
    • Breathing rate: 16 ± 3 times/minute.
    • Body temperature: 36.59 ± 0.43 ℃.
    • SpO2 from 95 to 100%.
  • Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
  • Not currently participating in other intervention studies.

Exclusion Criteria:

  • Having an inflammatory injury in the site of the skin to be investigated.
  • Medical history of asthma or allergy with moxa smoke.
  • Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24 hours.
  • Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
  • Other diseases that could affect or interfere with outcomes, including common cold or flu.
  • Playing sport 2 hours before the study.
  • Taking stimulants such as beer, alcohol, coffee and tobacco within 24 hours before conducting the study.
  • Skin surface temperature disorders or sensation disorders at lower-back or knee area.
  • Staying up at night or having insomnia before moxibustion day.
  • Women during menstruation period, pregnancy, or breastfeeding.
  • Currently using certain drugs which dilate blood vessels and drop in blood pressure.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

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: Group A: P1M2
19 participants received mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) and the research acupoint (Mingmen) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded.
Procedure: Mild moxibustion with moxa stick
To conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam.
Experimental: Group B: M1P2
19 participants received mild moxibustion manipulation at the research acupoint (Mingmen) and the control acupoint (the left side Pishu acupoint) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded.
Procedure: Mild moxibustion with moxa stick
To conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam.

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
Time Frame
Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint
Time Frame: During procedure
During procedure
Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint
Time Frame: During procedure
During procedure

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.
Bui Pham Minh Man

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
October 1, 2022

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, 2023

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.
June 30, 2023

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).
October 10, 2022

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.
October 10, 2022

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.
October 13, 2022

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.
October 23, 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.
October 18, 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.
October 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 677/HDDD-DHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographic characteristic and outcome data will be shared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings