Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity
NCT ID: NCT04606680
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2019-04-30
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
No
Sponsors
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Hubei Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Zhong-Yu Zhou, professor
Role: PRINCIPAL_INVESTIGATOR
Hubei Hospital of Traditional Chinese Medicine
Locations
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Zhong-Yu Zhou
Hubei, , China
Countries
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References
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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.
Other Identifiers
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20201020
Identifier Type: -
Identifier Source: org_study_id