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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04943705
• Other study ID #: HubeiHTCM
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2021
• Source: Hubei Hospital of Traditional Chinese Medicine
• Contact: Zhong-Yu Zhou, professor
• Phone: 18672308659
• Email: 2209447940[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
China	Zhong-Yu Zhou	Hubei
China	Hubei Provincial Hospital of Traditional Chinese Medicine	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist circumference	The change in waist circumference compared to the baseline.	Week 0, 4, 8, 12, 18and24.
Secondary	BMI(weight/height²)	BMI (weight/height²) will be measured.	Week 0, 4, 8, 12, 18and24.
Secondary	Weight(WG)	Weight(WG) will be measured.	Week 0, 4, 8, 12, 18and24.
Secondary	Hip circumference(HC)	Hip circumference(HC) will be measured.	Week 0, 4, 8, 12, 18and24.
Secondary	Waist-to-hip ratio(waist circumference/hip circumference)	Waist-to-hip ratio(waist circumference/hip circumference) will be measured.	Week 0, 4, 8, 12, 18and24.
Secondary	Body fat percentage(F percent)	Body fat percentage(F percent) will be measured.	Week 0, 4, 8, 12, 18and24.
Secondary	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.	Week 0, 12and24.
Secondary	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.	Week 0, 12and24.
Secondary	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.	Week 0, 12and24.
Secondary	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.	Week 0, 12and24.
Secondary	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.	Week 0 and 12.
Secondary	Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).	Compared with the baseline, the change value of this indicator.	Week 0 and12.