Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity

NCT04606680 | Unknown DMC

• 1 other identifier: 20201020
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

herb-partitioned moxibustion; simple obesity; a randomized controlled trial; effectiveness

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  week 4.

Secondary Outcomes (10)

• Weight(WG)

  week 0, 1, 2, 3, and 4

• BMI (weight/(height)

  week 0, 1, 2, 3, and 4

• Body fat percentage(F percent)

  week 0, 1, 2, 3, and 4

• Waist circumference(WC)

  week 0, 1, 2, 3, and 4

• hip circumference(HC)

  week 0, 1, 2, 3, and 4

Study Arms (3)

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.

Device: Heat application at acupoints

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.

Device: Medicated plaster at acupoints

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.

Device: Herb-partitioned moxibustion at acupoints

Interventions

Heat application at acupoints DEVICE

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.

Heat application group

Medicated plaster at acupoints DEVICE

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.

Medicated plaster group

Herb-partitioned moxibustion at acupoints DEVICE

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.

Herb-partitioned moxibustion group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hubei Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Zhong-Yu Zhou

Hubei, China

Location

Related Publications (1)

• 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.

  PMID: 33545941 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhong-Yu Zhou, professor

  Hubei Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 28, 2020
• Study Start: April 30, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2021
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

CN (1)