ObesityNCT04606680
Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity
A study testing Heat application at acupoints, Medicated plaster at acupoints and Herb-partitioned moxibustion at acupoints in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- Heat application at acupoints, Medicated plaster at acupoints and Herb-partitioned moxibustion at acupoints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Heat application at acupoints, Medicated plaster at acupoints, Herb-partitioned moxibustion at acupoints
- Keywords
- herb-partitioned moxibustion, simple obesity, a randomized controlled trial, effectiveness
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat application at acupointsDevice
- 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.
Medicated plaster at acupointsDevice
- 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.
Herb-partitioned moxibustion at acupointsDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Herb-partitioned moxibustion at acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4.
Secondary outcomes (10)
Weight(WG)
Weight(WG) will be measured.
Measured: week 0, 1, 2, 3, and 4
BMI (weight/(height)
BMI (weight/(height) will be measured.
Measured: week 0, 1, 2, 3, and 4
Body fat percentage(F percent)
Body fat percentage(F percent) will be measured.
Measured: week 0, 1, 2, 3, and 4
Waist circumference(WC)
Waist circumference(WC) will be measured.
Measured: week 0, 1, 2, 3, and 4
hip circumference(HC)
hip circumference(HC) will be measured.
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.
Measured: week 0, 1, 2, 3, and 4
Visceral fat area
Visceral fat area degree will be measured.
Measured: week 0, 1, 2, 3, and 4
Body fat Obesity degree
Body fat Obesity degree will be measured.
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.
Measured: 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.
Measured: week 0,1,2,3,4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start30 Apr 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhong-Yu Zhou, professor, Principal investigator, Hubei Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606680
- Sponsor's protocol ID
- 20201020
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33545941
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04606680
- Acronym / sponsor ID
- 20201020
- Conditions
- Obesity
- Keywords
- herb-partitioned moxibustion, simple obesity, a randomized controlled trial, effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hubei Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heat application group | Experimental | Device: Heat application at acupointsParticipants 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. |
| Medicated plaster group | Experimental | Device: Medicated plaster at acupointsParticipants 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. |
| Herb-partitioned moxibustion group | Experimental | Device: Herb-partitioned moxibustion at acupointsParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat application at acupoints1. 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 | Heat application group |
| Medicated plaster at acupoints1. 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 | Medicated plaster group |
| Herb-partitioned moxibustion at acupoints1. 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. | Device | Herb-partitioned moxibustion group |
Primary outcome
the clinical effectiveness
Time frame: week 4.
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.
10 secondary outcomes
Weight(WG)
Time frame: week 0, 1, 2, 3, and 4
BMI (weight/(height)
Time frame: week 0, 1, 2, 3, and 4
Body fat percentage(F percent)
Time frame: week 0, 1, 2, 3, and 4
Waist circumference(WC)
Time frame: week 0, 1, 2, 3, and 4
hip circumference(HC)
Time frame: week 0, 1, 2, 3, and 4
waist-to-hip ratio(waist circumference/hip circumference)
Time frame: week 0, 1, 2, 3, and 4
Visceral fat area
Time frame: week 0, 1, 2, 3, and 4
Body fat Obesity degree
Time frame: week 0, 1, 2, 3, and 4
the impact of weight on quality of life (IWQOL)-Lite scale
Time frame: week 0, 1, 2, 3, and 4
the syndrome score of Traditional Chinese Medicine
Time frame: week 0,1,2,3,4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 33545941Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong-Yu Zhou, professor principal investigator
Hubei Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat application at acupoints, Medicated plaster at acupoints and Herb-partitioned moxibustion at acupoints in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the clinical effectiveness (time frame: week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.