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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: Heat application at acupoints; Device: Medicated plaster at acupoints; Device: Herb-partitioned moxibustion at acupoints

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.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei, China
    • Zhong-Yu Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat application group; 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; 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.; 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.
Experimental: Medicated plaster group; 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; 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.; Lifestyle modification:It will be performed as the same as the heat application group.
Experimental: Herb-partitioned moxibustion group; 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; 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.; Lifestyle modification:It will be performed as the same as the heat application group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Healing: The clinical symptoms disappear or almost disappear, and the syndrome score is reduced by ≥85 percent;; Significant effect: The clinical symptoms are obviously improved, and the syndrome score is reduced by <85 percent, but ≥50 percent;; Effective: The clinical symptoms have improved, syndrome scores decreased by<50 percent, but ≥30 percent;; 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 Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: Hubei Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Zhong-Yu Zhou, professor, Hubei Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: effectiveness; herb-partitioned moxibustion; simple obesity; a randomized controlled trial
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20201020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No