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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yin and Yang Regulating Moxibustion
Sponsored by
Hubei Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Menopausal Obesity, Yin and Yang Regulating Moxibustion, A Randomized Controlled Trial

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hubei Provincial Hospital of Traditional Chinese Medicine
  • Zhong-Yu Zhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yin and Yang Regulating Moxibustion

Mild Moxibustion

Arm Description

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。

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.

Outcomes

Primary Outcome Measures

Waist circumference
The change in waist circumference compared to the baseline.

Secondary Outcome Measures

BMI(weight/height²)
BMI (weight/height²) will be measured.
Weight(WG)
Weight(WG) will be measured.
Hip circumference(HC)
Hip circumference(HC) will be measured.
Waist-to-hip ratio(waist circumference/hip circumference)
Waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Body fat percentage(F percent)
Body fat percentage(F percent) will be measured.
The syndrome score of Traditional Chinese Medicine
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.
The impact of weight on quality of life (IWQOL)-Lite scale
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.
Modified Kupperman score
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.
The MOS Item Short from Health Survey（SF-36).
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.
Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).
Compared with the baseline, the change value of this indicator.
Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
Compared with the baseline, the change value of this indicator.

Full Information

First Posted
June 13, 2021
Last Updated
June 27, 2021
Sponsor
Hubei Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04943705
Brief Title
Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity
Official Title
Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hubei Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Menopausal Obesity, Yin and Yang Regulating Moxibustion, A Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yin and Yang Regulating Moxibustion
Arm Type
Experimental
Arm Description
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。
Arm Title
Mild Moxibustion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Yin and Yang Regulating Moxibustion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Waist circumference
Description
The change in waist circumference compared to the baseline.
Time Frame
Week 0, 4, 8, 12, 18and24.
Secondary Outcome Measure Information:
Title
BMI(weight/height²)
Description
BMI (weight/height²) will be measured.
Time Frame
Week 0, 4, 8, 12, 18and24.
Title
Weight(WG)
Description
Weight(WG) will be measured.
Time Frame
Week 0, 4, 8, 12, 18and24.
Title
Hip circumference(HC)
Description
Hip circumference(HC) will be measured.
Time Frame
Week 0, 4, 8, 12, 18and24.
Title
Waist-to-hip ratio(waist circumference/hip circumference)
Description
Waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Time Frame
Week 0, 4, 8, 12, 18and24.
Title
Body fat percentage(F percent)
Description
Body fat percentage(F percent) will be measured.
Time Frame
Week 0, 4, 8, 12, 18and24.
Title
The syndrome score of Traditional Chinese Medicine
Description
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.
Time Frame
Week 0, 12and24.
Title
The impact of weight on quality of life (IWQOL)-Lite scale
Description
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.
Time Frame
Week 0, 12and24.
Title
Modified Kupperman score
Description
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.
Time Frame
Week 0, 12and24.
Title
The MOS Item Short from Health Survey（SF-36).
Description
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.
Time Frame
Week 0, 12and24.
Title
Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).
Description
Compared with the baseline, the change value of this indicator.
Time Frame
Week 0 and 12.
Title
Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
Description
Compared with the baseline, the change value of this indicator.
Time Frame
Week 0 and12.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Obesity in female menopause
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet the diagnostic criteria for menopausal syndrome and obesity; Patients with BMI≥25 and waist circumference≥80cm; Female patients between 40-60 years old; Have not taken any hormone drugs or weight loss related drugs in the past 3 months; Sign the informed consent and voluntarily accept the intervention methods of this project. Exclusion Criteria: Unexplained vaginal bleeding, or unnatural menopause; Have used hormone replacement therapy or other drugs related to this disease in the past 3 months; Combined with serious organic diseases, endocrine diseases, heart, liver and kidney, and respiratory diseases; Secondary obesity caused by hypothalamic lesions, hypothyroidism, glucocorticoid therapy, etc.; Combined with organic uterine diseases, such as polycystic ovary syndrome, malignant tumors, severe cervical erosion, after total hysterectomy, etc.; There are contraindications to moxibustion, such as moxibustion intolerance, skin allergies, scars, and other serious skin diseases; Poor compliance and unable to adhere to treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-Yu Zhou, professor
Phone
18672308659
Ext
86
Email
2209447940@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Huang, professor
Phone
13986083982
Ext
86
Email
huangwei@hbhtcm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Yu Zhou, professor
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei Provincial Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Facility Name
Zhong-Yu Zhou
City
Hubei
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35966744
Citation
Yu B, Huang W, Zhang Y, Wang J, Xia C, Zhang Y, Xia H, Hu Y, Rao Y, Zhou Z. Efficacy and Safety of Moxibustion for Menopausal Obesity: A Multicentre, Randomized, Controlled Trial Protocol. Evid Based Complement Alternat Med. 2022 Aug 4;2022:9255017. doi: 10.1155/2022/9255017. eCollection 2022.
Results Reference
derived

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

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