Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity

June 27, 2021 updated by: Hubei Hospital of Traditional Chinese Medicine
This study is designed as a two-dummy randomized controlled trial to evaluate the safety and superiority of Yin and Yang regulating moxibustion in the treatment of menopausal obese patients.

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.

Detailed Description

The study will be a multicenter, randomized, controlled trial, conducted from January 2021 to December 2022, including 216 menopausal obese patients who meet the inclusion criteria. The subjects will be randomly divided into 2 treatment groups: Yin and Yang regulating moxibustion group and mild moxibustion group. Each group of treatment will last for 12 weeks, with a follow-up period of 12 weeks. The main outcome indicator is waist circumference. The secondary outcome indicators include subjects related to obesity, TCM clinical syndrome score and modified Kupperman score, weight impact on quality of life scale (IWQOL-Lite), quality of life assessment health survey summary (SF-36). During the intervention period, adverse events will be recorded.

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.
216

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: Zhong-Yu Zhou, professor
  • Phone Number: 86 18672308659
  • Email: 2209447940@qq.com

Study Contact Backup

Study Locations

  • China
      • Hubei, China
        • Zhong-Yu Zhou
    • Hubei
      • Wuhan, Hubei, China, 430061
        • Hubei Provincial Hospital of Traditional Chinese Medicine

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients who meet the diagnostic criteria for menopausal syndrome and obesity;
  2. Patients with BMI≥25 and waist circumference≥80cm;
  3. Female patients between 40-60 years old;
  4. Have not taken any hormone drugs or weight loss related drugs in the past 3 months;
  5. Sign the informed consent and voluntarily accept the intervention methods of this project.

Exclusion Criteria:

  1. Unexplained vaginal bleeding, or unnatural menopause;
  2. Have used hormone replacement therapy or other drugs related to this disease in the past 3 months;
  3. Combined with serious organic diseases, endocrine diseases, heart, liver and kidney, and respiratory diseases;
  4. Secondary obesity caused by hypothalamic lesions, hypothyroidism, glucocorticoid therapy, etc.;
  5. Combined with organic uterine diseases, such as polycystic ovary syndrome, malignant tumors, severe cervical erosion, after total hysterectomy, etc.;
  6. There are contraindications to moxibustion, such as moxibustion intolerance, skin allergies, scars, and other serious skin diseases;
  7. Poor compliance and unable to adhere to treatment.

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 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: Yin and Yang Regulating Moxibustion
1.The acupoints will be selected as Shenque and Mingmen.The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.Each treatment was 60min, once a week, Wenyang Yishen moxibustion and Peiyuan Guben moxibustion were performed alternately. Each patient received WenYang Yishen moxibustion and then Peiyuan Guben moxibustion for a total of 12 weeks of treatment and 12 weeks of follow-up at the end of the treatment. 2.The diet and exercise control implementation plan is as follows:Participants weighed ≤113.6 kg (250 lbs) and had a prescription diet of 1200-1499 kcal/day, including traditional foods, of which protein was about 15-20 kcal, fat was about 20-35%, and the rest came from carbohydrates. People weighing ≥113.6 kg are prescribed 1500-1800 kcal per day. They were also instructed to continue moderate-intensity physical activities (such as jogging, brisk walking) at least 5 days a week, at least 210 minutes a week, preferably ≥270 minutes a week。
Device: Yin and Yang Regulating Moxibustion
Before making Wenyang Yishen moxibustion, the width and length of the patient's moxibustion site were evaluated by the same body measurement method. Take about 700g of fresh ground ginger with moderate dryness and wetness, and place it on the treatment towel to make a round cake with a diameter of about 20cm and a thickness of about 2.5cm. Spread 25g of moxa moxa with a diameter of about 18cm on top of ginger and light it. When the bottom temperature reaches about 37 degrees, the door can be placed on the patient's waist for treatment. According to the patient's tolerance, the temperature should be controlled at 43-45 degrees. It is better to replace the moxa biscuit every time when the moxa biscuit is burned for about 10 minutes. The patient's local skin has a slight redness and burning. The moxibustion time is 60 minutes. Peiyuan Guben moxibustion is centered on Shenque, and the operation is the same as that of WenYang and Yishen moxibustion.
Active Comparator: Mild Moxibustion
1.The acupoints will be selected as Zhongwan, Guanyuan, Sanyinjiao (double).The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.Light one end of the moxa stick and hang it about 2-3cm above the skin, taking the patient's local skin redness and conscious warmth as the degree. Moxa-box moxibustion will be used for 20 minutes each treatment, once every other day, 3 times a week, for a total of 12 weeks of treatment, and 12 weeks of follow-up after the treatment. 2.Lifestyle modification:It will be performed as the same as the Yin and Yang Regulating Moxibustion group.
Device: Yin and Yang Regulating Moxibustion
Before making Wenyang Yishen moxibustion, the width and length of the patient's moxibustion site were evaluated by the same body measurement method. Take about 700g of fresh ground ginger with moderate dryness and wetness, and place it on the treatment towel to make a round cake with a diameter of about 20cm and a thickness of about 2.5cm. Spread 25g of moxa moxa with a diameter of about 18cm on top of ginger and light it. When the bottom temperature reaches about 37 degrees, the door can be placed on the patient's waist for treatment. According to the patient's tolerance, the temperature should be controlled at 43-45 degrees. It is better to replace the moxa biscuit every time when the moxa biscuit is burned for about 10 minutes. The patient's local skin has a slight redness and burning. The moxibustion time is 60 minutes. Peiyuan Guben moxibustion is centered on Shenque, and the operation is the same as that of WenYang and Yishen moxibustion.

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
Waist circumference
Time Frame: Week 0, 4, 8, 12, 18and24.
The change in waist circumference compared to the baseline.
Week 0, 4, 8, 12, 18and24.

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
BMI(weight/height²)
Time Frame: Week 0, 4, 8, 12, 18and24.
BMI (weight/height²) will be measured.
Week 0, 4, 8, 12, 18and24.
Weight(WG)
Time Frame: Week 0, 4, 8, 12, 18and24.
Weight(WG) will be measured.
Week 0, 4, 8, 12, 18and24.
Hip circumference(HC)
Time Frame: Week 0, 4, 8, 12, 18and24.
Hip circumference(HC) will be measured.
Week 0, 4, 8, 12, 18and24.
Waist-to-hip ratio(waist circumference/hip circumference)
Time Frame: Week 0, 4, 8, 12, 18and24.
Waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Week 0, 4, 8, 12, 18and24.
Body fat percentage(F percent)
Time Frame: Week 0, 4, 8, 12, 18and24.
Body fat percentage(F percent) will be measured.
Week 0, 4, 8, 12, 18and24.
The syndrome score of Traditional Chinese Medicine
Time Frame: Week 0, 12and24.
The syndrome score of Traditional Chinese Medicine will be adopted as the criterion of syndrome determination according to the diagnostic and therapeutic evaluation standard of simple obesity revised by the 5th National Obesity Research Conference in 1997. The minimum value is 0#the maximum value is 30. The lower the total score, the better of the outcome.
Week 0, 12and24.
The impact of weight on quality of life (IWQOL)-Lite scale
Time Frame: Week 0, 12and24.
The impact of weight on quality of life (IWQOL)- Lite scale will be measured. The minimum value is 31#the maximum value is 155. The lower the total score, the lighter the clinical symptoms of the patient.
Week 0, 12and24.
Modified Kupperman score
Time Frame: Week 0, 12and24.
The modified KMI score scale was used to evaluate the clinical symptoms of menopause before and after treatment.The minimum value is 0#the maximum value is 63. The lower the total score, the lighter the clinical symptoms of the patient.
Week 0, 12and24.
The MOS Item Short from Health Survey（SF-36).
Time Frame: Week 0, 12and24.
This scale is a universal health-related quality of life scale. The minimum value is 40#the maximum value is 147.The higher the comprehensive score, the better the quality of life.
Week 0, 12and24.
Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).
Time Frame: Week 0 and 12.
Compared with the baseline, the change value of this indicator.
Week 0 and 12.
Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
Time Frame: Week 0 and12.
Compared with the baseline, the change value of this indicator.
Week 0 and12.

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.
Hubei Hospital of Traditional Chinese Medicine

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: Zhong-Yu Zhou, professor, Hubei Hospital of Traditional Chinese Medicine

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.

General Publications

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.
July 1, 2021

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.
December 30, 2021

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.
December 30, 2022

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).
June 13, 2021

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.
June 27, 2021

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.
June 29, 2021

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.
June 29, 2021

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.
June 27, 2021

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.
June 1, 2021

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.
  • HubeiHTCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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