Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity
1 other identifier
interventional
216
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJune 29, 2021
June 1, 2021
6 months
June 13, 2021
June 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Waist circumference
The change in waist circumference compared to the baseline.
Week 0, 4, 8, 12, 18and24.
Secondary Outcomes (11)
BMI(weight/height²)
Week 0, 4, 8, 12, 18and24.
Weight(WG)
Week 0, 4, 8, 12, 18and24.
Hip circumference(HC)
Week 0, 4, 8, 12, 18and24.
Waist-to-hip ratio(waist circumference/hip circumference)
Week 0, 4, 8, 12, 18and24.
Body fat percentage(F percent)
Week 0, 4, 8, 12, 18and24.
- +6 more secondary outcomes
Study Arms (2)
Yin and Yang Regulating Moxibustion
EXPERIMENTAL1.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。
Mild Moxibustion
ACTIVE COMPARATOR1.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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430061, China
Zhong-Yu Zhou
Hubei, China
Related Publications (1)
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.
PMID: 35966744DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhong-Yu Zhou, professor
Hubei Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2021
First Posted
June 29, 2021
Study Start
July 1, 2021
Primary Completion
December 30, 2021
Study Completion
December 30, 2022
Last Updated
June 29, 2021
Record last verified: 2021-06