Obesity
Conditions
Keywords
Menopausal Obesity, Yin and Yang Regulating Moxibustion, A Randomized Controlled Trial
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.
Interventions
DEVICEYin 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.
Sponsors
Hubei Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Week 0, 4, 8, 12, 18and24. | The change in waist circumference compared to the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI(weight/height²) | Week 0, 4, 8, 12, 18and24. | BMI (weight/height²) will be measured. |
| Weight(WG) | Week 0, 4, 8, 12, 18and24. | Weight(WG) will be measured. |
| Hip circumference(HC) | Week 0, 4, 8, 12, 18and24. | Hip circumference(HC) will be measured. |
| Waist-to-hip ratio(waist circumference/hip circumference) | Week 0, 4, 8, 12, 18and24. | Waist-to-hip ratio(waist circumference/hip circumference) will be measured. |
| Body fat percentage(F percent) | Week 0, 4, 8, 12, 18and24. | Body fat percentage(F percent) will be measured. |
| Estrogen: estradiol (E2), serum follicle-forming hormone (FSH). | Week 0 and12. | Compared with the baseline, the change value of this indicator. |
| The impact of weight on quality of life (IWQOL)-Lite scale | 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. |
| Modified Kupperman score | 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. |
| The MOS Item Short from Health Survey（SF-36). | 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. |
| Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C). | Week 0 and 12. | Compared with the baseline, the change value of this indicator. |
| The syndrome score of Traditional Chinese Medicine | 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. |
Countries
China
Contacts
Primary ContactZhong-Yu Zhou, professor
Backup ContactWei Huang, professor
Outcome results
None listed