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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat application group | Experimental | 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. |
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| Medicated plaster group | Experimental | 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. |
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| Herb-partitioned moxibustion group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat application at acupoints | Device |
The proportion of three nutrients in total calories comprises of 55%-65% from carbohydrates, 20%-30% from oils and 15% from protein, and the energy of the whole day distributed to three meals will follow the proportion of 30% for breakfast, 40% for lunch and 30% for dinner. Meanwhile, low-to-moderate intensity physical activities will be instructed to them for at least 5 days per week continually, 30%-50% of the maximum heart rate reserve value will be required. |
| Measure | Description | Time Frame |
|---|---|---|
| the clinical effectiveness | 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:
Integral variation formula(Nimodipine method: [(pre-treatment score-post-treatment score)/pre-treatment score]X100 percent. | week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight(WG) | Weight(WG) will be measured. | week 0, 1, 2, 3, and 4 |
| BMI (weight/(height) | BMI (weight/(height) will be measured. | week 0, 1, 2, 3, and 4 |
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Inclusion Criteria:
Participants meeting all of the following criteria will be considered for inclusion:
Exclusion Criteria:
Participants will be excluded if they have
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| Name | Affiliation | Role |
|---|---|---|
| Zhong-Yu Zhou, professor | Hubei Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhong-Yu Zhou | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33545941 | Derived | Wang LH, Lv SY, Liu YR, Chen X, Wang JJ, Huang W, Zhou ZY. Comparative effectiveness of herb-partitioned moxibustion plus lifestyle modification treatment for patients with simple obesity: A study protocol for a randomized controlled trial. Medicine (Baltimore). 2021 Jan 22;100(3):e23758. doi: 10.1097/MD.0000000000023758. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Medicated plaster at acupoints | Device |
|
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| Herb-partitioned moxibustion at acupoints | Device |
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| Body fat percentage(F percent) | Body fat percentage(F percent) will be measured. | week 0, 1, 2, 3, and 4 |
| Waist circumference(WC) | Waist circumference(WC) will be measured. | week 0, 1, 2, 3, and 4 |
| hip circumference(HC) | hip circumference(HC) will be measured. | week 0, 1, 2, 3, and 4 |
| waist-to-hip ratio(waist circumference/hip circumference) | waist-to-hip ratio(waist circumference/hip circumference) will be measured. | week 0, 1, 2, 3, and 4 |
| Visceral fat area | Visceral fat area degree will be measured. | week 0, 1, 2, 3, and 4 |
| Body fat Obesity degree | Body fat Obesity degree will be measured. | week 0, 1, 2, 3, and 4 |
| the impact of weight on quality of life (IWQOL)-Lite scale | 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. | week 0, 1, 2, 3, and 4 |
| 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 18. The lower the total score, the better of the outcome. | week 0,1,2,3,4. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |