Back to resultsHerb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Heat application at acupoints
Medicated plaster at acupoints
Herb-partitioned moxibustion at acupoints
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring herb-partitioned moxibustion, simple obesity, a randomized controlled trial, effectiveness
Eligibility Criteria
Inclusion Criteria:
Participants meeting all of the following criteria will be considered for inclusion:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Zhong-Yu Zhou
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Heat application group
Medicated plaster group
Herb-partitioned moxibustion group
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Weight(WG)
Weight(WG) will be measured.
BMI (weight/(height)
BMI (weight/(height) will be measured.
Body fat percentage(F percent)
Body fat percentage(F percent) will be measured.
Waist circumference(WC)
Waist circumference(WC) will be measured.
hip circumference(HC)
hip circumference(HC) will be measured.
waist-to-hip ratio(waist circumference/hip circumference)
waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Visceral fat area
Visceral fat area degree will be measured.
Body fat Obesity degree
Body fat Obesity degree will be measured.
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.
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.
Full Information
NCT ID
NCT04606680
First Posted
October 20, 2020
Last Updated
October 27, 2020
Sponsor
Hubei Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04606680
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hubei Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
herb-partitioned moxibustion, simple obesity, a randomized controlled trial, effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heat application group
Arm Type
Experimental
Arm 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.
Arm Title
Medicated plaster group
Arm Type
Experimental
Arm 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.
Arm Title
Herb-partitioned moxibustion group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Heat application at acupoints
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Medicated plaster at acupoints
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Herb-partitioned moxibustion at acupoints
Intervention Description
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.
Primary Outcome Measure Information:
Title
the clinical effectiveness
Description
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.
Time Frame
week 4.
Secondary Outcome Measure Information:
Title
Weight(WG)
Description
Weight(WG) will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
BMI (weight/(height)
Description
BMI (weight/(height) will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
Body fat percentage(F percent)
Description
Body fat percentage(F percent) will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
Waist circumference(WC)
Description
Waist circumference(WC) will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
hip circumference(HC)
Description
hip circumference(HC) will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
waist-to-hip ratio(waist circumference/hip circumference)
Description
waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
Visceral fat area
Description
Visceral fat area degree will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
Body fat Obesity degree
Description
Body fat Obesity degree will be measured.
Time Frame
week 0, 1, 2, 3, and 4
Title
the impact of weight on quality of life (IWQOL)-Lite scale
Description
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.
Time Frame
week 0, 1, 2, 3, and 4
Title
the syndrome score of Traditional Chinese Medicine
Description
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.
Time Frame
week 0,1,2,3,4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants meeting all of the following criteria will be considered for inclusion:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Yu Zhou, professor
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhong-Yu Zhou
City
Hubei
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33545941
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.
Results Reference
derived
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Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity
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