Clinical trial NCT04606680: Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity
Official title: Comparative Effectiveness of Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Patients With Simple Obesity: A Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: herb-partitioned moxibustion
simple obesity
a randomized controlled trial
effectiveness
Lead sponsor: Hubei Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Participants meeting all of the following criteria will be considered for inclusion:

1. diagnosed as having simple obesity according to the diagnostic criteria;
2. aged between 18 and 45 years old;
3. Waistline: male≥ 95 cm, women≥85 cm;
4. Being able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

Participants will be excluded if they have

1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
3. Pregnant or lactating state, women who plan to become pregnant within 4 weeks.
4. History of bulimia, anorexia, or any other eating disorders.
5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
6. History of surgical weight loss, postoperative adhesions.
7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
8. Presence of local skin rupture, allergy and scar constitution.
9. Unable to cooperate with the research caused by other diseases or reasons.

Primary outcomes:
measure: the clinical effectiveness
timeFrame: week 4.
Secondary outcomes:
measure: Weight(WG)
timeFrame: week 0, 1, 2, 3, and 4
measure: BMI (weight/(height)
timeFrame: week 0, 1, 2, 3, and 4
measure: Body fat percentage(F percent)
timeFrame: week 0, 1, 2, 3, and 4
measure: Waist circumference(WC)
timeFrame: week 0, 1, 2, 3, and 4
measure: hip circumference(HC)
timeFrame: week 0, 1, 2, 3, and 4
measure: waist-to-hip ratio(waist circumference/hip circumference)
timeFrame: week 0, 1, 2, 3, and 4
measure: Visceral fat area
timeFrame: week 0, 1, 2, 3, and 4
measure: Body fat Obesity degree
timeFrame: week 0, 1, 2, 3, and 4
measure: the impact of weight on quality of life (IWQOL)-Lite scale
timeFrame: week 0, 1, 2, 3, and 4
measure: the syndrome score of Traditional Chinese Medicine
timeFrame: week 0,1,2,3,4.
Other outcomes:
Locations:
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: 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.