Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity

Hubei Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Obesity

Treatments: Device: Heat application at acupoints; Device: Medicated plaster at acupoints; Device: Herb-partitioned moxibustion at acupoints

Study type: Interventional

Funder types: Other

Identifiers

NCT04606680

20201020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

Heat application group

Experimental group

Description:

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.

Treatment:

Device: Heat application at acupoints

Medicated plaster group

Experimental group

Description:

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.

Treatment:

Device: Medicated plaster at acupoints

Herb-partitioned moxibustion group

Experimental group

Description:

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.

Treatment:

Device: Herb-partitioned moxibustion at acupoints