Clinical trial NCT04943705: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Menopausal Obesity
Yin and Yang Regulating Moxibustion
A Randomized Controlled Trial
Lead sponsor: Hubei Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 216
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Waist circumference
timeFrame: Week 0, 4, 8, 12, 18and24.
Secondary outcomes:
measure: BMI(weight/height²)
timeFrame: Week 0, 4, 8, 12, 18and24.
measure: Weight(WG)
timeFrame: Week 0, 4, 8, 12, 18and24.
measure: Hip circumference(HC)
timeFrame: Week 0, 4, 8, 12, 18and24.
measure: Waist-to-hip ratio(waist circumference/hip circumference)
timeFrame: Week 0, 4, 8, 12, 18and24.
measure: Body fat percentage(F percent)
timeFrame: Week 0, 4, 8, 12, 18and24.
measure: The syndrome score of Traditional Chinese Medicine
timeFrame: Week 0, 12and24.
measure: The impact of weight on quality of life (IWQOL)-Lite scale
timeFrame: Week 0, 12and24.
measure: Modified Kupperman score
timeFrame: Week 0, 12and24.
measure: The MOS Item Short from Health Survey（SF-36).
timeFrame: Week 0, 12and24.
measure: Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).
timeFrame: Week 0 and 12.
measure: Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
timeFrame: Week 0 and12.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Hospital of Traditional Chinese Medicine
state: Hubei
city: Hubei
country: China
facility: Zhong-Yu Zhou
Study officials:
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Zhong-Yu Zhou, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.