Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity
- Conditions
- Obesity
- Interventions
- Device: Herb-partitioned moxibustion at acupointsDevice: Heat application at acupointsDevice: Medicated plaster at acupoints
- Registration Number
- NCT04606680
- Lead Sponsor
- Hubei Hospital of Traditional Chinese Medicine
- Brief Summary
This study is designed as a three-dummy randomised controlled trial to evaluate the efficacy and safety of herb-partitioned moxibustion plus lifestyle modification treatment in patients with simple obesity.
- Detailed Description
This study will be a multicenter, randomized, controlled trial conducted from November, 2018 to November, 2019 that includes 108 participants who have simple obesity and meet the eligibility criteria. The participants will be randomly divided into 3 treatment groups: heat application group, medicated plaster group, or herb-partitioned moxibustion group. Each treatment will last 4 weeks. The primary outcomes will be the clinical effectiveness.The secondary outcome measures include participants'obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine. Adverse events will be recorded during the intervention period.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 108
Participants meeting all of the following criteria will be considered for inclusion:
- diagnosed as having simple obesity according to the diagnostic criteria;
- aged between 18 and 45 years old;
- Waistline: male≥ 95 cm, women≥85 cm;
- Being able to fully understand and voluntarily sign informed consent.
Participants will be excluded if they have
- Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
- Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
- Pregnant or lactating state, women who plan to become pregnant within 4 weeks.
- History of bulimia, anorexia, or any other eating disorders.
- Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
- History of surgical weight loss, postoperative adhesions.
- History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
- Presence of local skin rupture, allergy and scar constitution.
- Unable to cooperate with the research caused by other diseases or reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herb-partitioned moxibustion group Herb-partitioned moxibustion at acupoints Participants will receive herb-partitioned moxibustion at acupoints plus lifestyle modification. Participants will receive herb-partitioned moxibustion at acupoints and lifestyle modification every once every other day, 3 times per week, for 4 consecutive weeks. Heat application group Heat application at acupoints Participants will receive heat application at acupoints plus lifestyle modification. Participants will receive heat application treatment once every other day, 3 times per week, for 4 consecutive weeks. Medicated plaster group Medicated plaster at acupoints Participants will receive medicated plaster at acupoints plus lifestyle modification. Participants will receive medicated plaster at acupoints and lifestyle modification every once every other day, 3 times per week, for 4 consecutive weeks.
- Primary Outcome Measures
Name Time Method the clinical effectiveness week 4. The clinical effectiveness of 4 weeks of (A)Heat application group, (B)Medicated plaster group, and (C)Herb-partitioned moxibustion group for the improvement of simple obesity will be assessed and determined by the clinical evaluation of nimodipine:
1. Healing: The clinical symptoms disappear or almost disappear, and the syndrome score is reduced by ≥85 percent;
2. Significant effect: The clinical symptoms are obviously improved, and the syndrome score is reduced by \<85 percent, but ≥50 percent;
3. Effective: The clinical symptoms have improved, syndrome scores decreased by\<50 percent, but ≥30 percent;
4. Invalid: The clinical symptoms were not improved, even worse, and the syndrome score was reduced by\<30 percent.
Integral variation formula(Nimodipine method: \[(pre-treatment score-post-treatment score)/pre-treatment score\]X100 percent.
- Secondary Outcome Measures
Name Time Method Body fat Obesity degree week 0, 1, 2, 3, and 4 Body fat Obesity degree will be measured.
Body fat percentage(F percent) week 0, 1, 2, 3, and 4 Body fat percentage(F percent) will be measured.
the impact of weight on quality of life (IWQOL)-Lite scale week 0, 1, 2, 3, and 4 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.
Waist circumference(WC) week 0, 1, 2, 3, and 4 Waist circumference(WC) will be measured.
hip circumference(HC) week 0, 1, 2, 3, and 4 hip circumference(HC) will be measured.
the syndrome score of Traditional Chinese Medicine week 0,1,2,3,4. 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 18. The lower the total score, the better of the outcome.
Weight(WG) week 0, 1, 2, 3, and 4 Weight(WG) will be measured.
waist-to-hip ratio(waist circumference/hip circumference) week 0, 1, 2, 3, and 4 waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Visceral fat area week 0, 1, 2, 3, and 4 Visceral fat area degree will be measured.
BMI (weight/(height) week 0, 1, 2, 3, and 4 BMI (weight/(height) will be measured.
Trial Locations
- Locations (1)
Zhong-Yu Zhou
🇨🇳Hubei, China