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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
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.
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
Zhong-Yu Zhou
Hubei, China
Waist circumference
The change in waist circumference compared to the baseline.
Time frame: Week 0, 4, 8, 12, 18and24.
BMI(weight/height²)
BMI (weight/height²) will be measured.
Time frame: Week 0, 4, 8, 12, 18and24.
Weight(WG)
Weight(WG) will be measured.
Time frame: Week 0, 4, 8, 12, 18and24.
Hip circumference(HC)
Hip circumference(HC) will be measured.
Time frame: Week 0, 4, 8, 12, 18and24.
Waist-to-hip ratio(waist circumference/hip circumference)
Waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Time frame: Week 0, 4, 8, 12, 18and24.
Body fat percentage(F percent)
Body fat percentage(F percent) will be measured.
Time frame: Week 0, 4, 8, 12, 18and24.
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.
Time frame: Week 0, 12and24.
The impact of weight on quality of life (IWQOL)-Lite scale
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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.
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.
Time frame: Week 0, 12and24.
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.
Time frame: Week 0, 12and24.
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.
Time frame: Week 0 and 12.
Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
Compared with the baseline, the change value of this indicator.
Time frame: Week 0 and12.