NCT04606680

Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity

Comparative Effectiveness of Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Patients With Simple Obesity: A Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Hubei Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Heat application at acupoints	1. The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard. The hot sticker will be placed on the patient's acupoints for about 2 hours. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period. 2. The following lifestyle modification are recommended to help to establish healthy habits: 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.
DEVICE	Medicated plaster at acupoints	1. The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.The chinese traditional medicine(aconite root, dried ginger, evodia rutaecarpa, clove, cinnamon, etc)in moderation will be grinded into powder，and the powder will be added with a certain amount of flour, and finally they will be blended with ginger juice to the appearance of mud. Next, 10g of the kneaded medicine mud will be taked and applied to the bottom of the ordinary sticker. They will be placed on the patient's acupoints for about 2 hours. The sticker has the same shape as the hot sticker, but it does not have the effect of thermal stimulation and infrared radiation. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period. 2. Lifestyle modification:It will be performed as the same as the heat application group.
DEVICE	Herb-partitioned moxibustion at acupoints	1. The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard\[18\]. The chinese traditional medicine(aconite root, dried ginger, evodia rutaecarpa, clove, cinnamon, etc)in moderation will be grinded into powder，and the powder will be added with a certain amount of flour, and finally they will be blended with ginger juice to the appearance of mud. Next, 10g of the kneaded medicine mud will be taked and applied to the bottom of the hot sticker. They will be placed on the patient's acupoints for about 2 hours. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period. 2. Lifestyle modification:It will be performed as the same as the heat application group.

Timeline

• Start date: 2019-04-30
• Primary completion: 2020-04-30
• Completion: 2021-04-30
• First posted: 2020-10-28
• Last updated: 2020-10-28

Locations

1 site across 1 country: China