ObesityNCT04943705
Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity
A study testing Yin and Yang Regulating Moxibustion in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine at 2 sites in China.
Trial summary
This study is designed as a two-dummy randomized controlled trial to evaluate the safety and superiority of Yin and Yang regulating moxibustion in the treatment of menopausal obese patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Yin and Yang Regulating Moxibustion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2021to 30 Dec 2022
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who meet the diagnostic criteria for menopausal syndrome and obesity;
- Patients with BMI≥25 and waist circumference≥80cm;
- Female patients between 40-60 years old;
- Have not taken any hormone drugs or weight loss related drugs in the past 3 months;
- Sign the informed consent and voluntarily accept the intervention methods of this project.
Who cannot join
- Unexplained vaginal bleeding, or unnatural menopause;
- Have used hormone replacement therapy or other drugs related to this disease in the past 3 months;
- Combined with serious organic diseases, endocrine diseases, heart, liver and kidney, and respiratory diseases;
- Secondary obesity caused by hypothalamic lesions, hypothyroidism, glucocorticoid therapy, etc.;
- Combined with organic uterine diseases, such as polycystic ovary syndrome, malignant tumors, severe cervical erosion, after total hysterectomy, etc.;
- There are contraindications to moxibustion, such as moxibustion intolerance, skin allergies, scars, and other serious skin diseases;
- Poor compliance and unable to adhere to treatment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhong-Yu Zhou
Hubei
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430061
About this study
This study is designed as a two-dummy randomized controlled trial to evaluate the safety and superiority of Yin and Yang regulating moxibustion in the treatment of menopausal obese patients.
Read the detailed description
The study will be a multicenter, randomized, controlled trial, conducted from January 2021 to December 2022, including 216 menopausal obese patients who meet the inclusion criteria. The subjects will be randomly divided into 2 treatment groups: Yin and Yang regulating moxibustion group and mild moxibustion group. Each group of treatment will last for 12 weeks, with a follow-up period of 12 weeks. The main outcome indicator is waist circumference. The secondary outcome indicators include subjects related to obesity, TCM clinical syndrome score and modified Kupperman score, weight impact on quality of life scale (IWQOL-Lite), quality of life assessment health survey summary (SF-36). During the intervention period, adverse events will be recorded.
- Conditions
- Obesity
- Being tested
- Yin and Yang Regulating Moxibustion
- Keywords
- Menopausal Obesity, Yin and Yang Regulating Moxibustion, A Randomized Controlled Trial
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yin and Yang Regulating MoxibustionDevice
Before making Wenyang Yishen moxibustion, the width and length of the patient's moxibustion site were evaluated by the same body measurement method. Take about 700g of fresh ground ginger with moderate dryness and wetness, and place it on the treatment towel to make a round cake with a diameter of about 20cm and a thickness of about 2.5cm. Spread 25g of moxa moxa with a diameter of about 18cm on top of ginger and light it. When the bottom temperature reaches about 37 degrees, the door can be placed on the patient's waist for treatment. According to the patient's tolerance, the temperature should be controlled at 43-45 degrees. It is better to replace the moxa biscuit every time when the moxa biscuit is burned for about 10 minutes. The patient's local skin has a slight redness and burning. The moxibustion time is 60 minutes. Peiyuan Guben moxibustion is centered on Shenque, and the operation is the same as that of WenYang and Yishen moxibustion.
| Study group | Role | What they receive |
|---|---|---|
| Yin and Yang Regulating Moxibustion | Experimental | 1.The acupoints will be selected as Shenque and Mingmen.The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.Each treatment was 60min, once a week, Wenyang Yishen moxibustion and Peiyuan Guben moxibustion were performed alternately. Each patient received WenYang Yishen moxibustion and then Peiyuan Guben moxibustion for a total of 12 weeks of treatment and 12 weeks of follow-up at the end of the treatment. 2.The diet and exercise control implementation plan is as follows:Participants weighed ≤113.6 kg (250 lbs) and had a prescription diet of 1200-1499 kcal/day, including traditional foods, of which protein was about 15-20 kcal, fat was about 20-35%, and the rest came from carbohydrates. People weighing ≥113.6 kg are prescribed 1500-1800 kcal per day. They were also instructed to continue moderate-intensity physical activities (such as jogging, brisk walking) at least 5 days a week, at least 210 minutes a week, preferably ≥270 minutes a week。 Receives: Device: Yin and Yang Regulating Moxibustion |
| Mild Moxibustion | Active comparator | 1.The acupoints will be selected as Zhongwan, Guanyuan, Sanyinjiao (double).The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.Light one end of the moxa stick and hang it about 2-3cm above the skin, taking the patient's local skin redness and conscious warmth as the degree. Moxa-box moxibustion will be used for 20 minutes each treatment, once every other day, 3 times a week, for a total of 12 weeks of treatment, and 12 weeks of follow-up after the treatment. 2.Lifestyle modification:It will be performed as the same as the Yin and Yang Regulating Moxibustion group. Receives: Device: Yin and Yang Regulating Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
The change in waist circumference compared to the baseline.
Measured: Week 0, 4, 8, 12, 18and24.
Secondary outcomes (11)
BMI(weight/height²)
BMI (weight/height²) will be measured.
Measured: Week 0, 4, 8, 12, 18and24.
Weight(WG)
Weight(WG) will be measured.
Measured: Week 0, 4, 8, 12, 18and24.
Hip circumference(HC)
Hip circumference(HC) will be measured.
Measured: Week 0, 4, 8, 12, 18and24.
Waist-to-hip ratio(waist circumference/hip circumference)
Waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Measured: Week 0, 4, 8, 12, 18and24.
Body fat percentage(F percent)
Body fat percentage(F percent) will be measured.
Measured: Week 0, 4, 8, 12, 18and24.
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 30. The lower the total score, the better of the outcome.
Measured: Week 0, 12and24.
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, 12and24.
Modified Kupperman score
The modified KMI score scale was used to evaluate the clinical symptoms of menopause before and after treatment.The minimum value is 0#the maximum value is 63. The lower the total score, the lighter the clinical symptoms of the patient.
Measured: Week 0, 12and24.
The MOS Item Short from Health Survey（SF-36).
This scale is a universal health-related quality of life scale. The minimum value is 40#the maximum value is 147.The higher the comprehensive score, the better the quality of life.
Measured: Week 0, 12and24.
Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).
Compared with the baseline, the change value of this indicator.
Measured: Week 0 and 12.
Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
Compared with the baseline, the change value of this indicator.
Measured: Week 0 and12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (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
- 216 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
- NCT04943705
- Sponsor's protocol ID
- HubeiHTCM
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu B, Huang W, Zhang Y, Wang J, Xia C, Zhang Y, Xia H, Hu Y, Rao Y, Zhou Z. Efficacy and Safety of Moxibustion for Menopausal Obesity: A Multicentre, Randomized, Controlled Trial Protocol. Evid Based Complement Alternat Med. 2022 Aug 4;2022:9255017. doi: 10.1155/2022/9255017. eCollection 2022.
PubMed 35966744
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity
- ClinicalTrials.gov ID
- NCT04943705
- Acronym / sponsor ID
- HubeiHTCM
- Conditions
- Obesity
- Keywords
- Menopausal Obesity, Yin and Yang Regulating Moxibustion, A Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Hubei Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Jun 2021 (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 two-dummy randomized controlled trial to evaluate the safety and superiority of Yin and Yang regulating moxibustion in the treatment of menopausal obese patients.
Detailed description
The study will be a multicenter, randomized, controlled trial, conducted from January 2021 to December 2022, including 216 menopausal obese patients who meet the inclusion criteria. The subjects will be randomly divided into 2 treatment groups: Yin and Yang regulating moxibustion group and mild moxibustion group. Each group of treatment will last for 12 weeks, with a follow-up period of 12 weeks. The main outcome indicator is waist circumference. The secondary outcome indicators include subjects related to obesity, TCM clinical syndrome score and modified Kupperman score, weight impact on quality of life scale (IWQOL-Lite), quality of life assessment health survey summary (SF-36). During the intervention period, adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yin and Yang Regulating Moxibustion | Experimental | Device: Yin and Yang Regulating Moxibustion1.The acupoints will be selected as Shenque and Mingmen.The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.Each treatment was 60min, once a week, Wenyang Yishen moxibustion and Peiyuan Guben moxibustion were performed alternately. Each patient received WenYang Yishen moxibustion and then Peiyuan Guben moxibustion for a total of 12 weeks of treatment and 12 weeks of follow-up at the end of the treatment. 2.The diet and exercise control implementation plan is as follows:Participants weighed ≤113.6 kg (250 lbs) and had a prescription diet of 1200-1499 kcal/day, including traditional foods, of which protein was about 15-20 kcal, fat was about 20-35%, and the rest came from carbohydrates. People weighing ≥113.6 kg are prescribed 1500-1800 kcal per day. They were also instructed to continue moderate-intensity physical activities (such as jogging, brisk walking) at least 5 days a week, at least 210 minutes a week, preferably ≥270 minutes a week。 |
| Mild Moxibustion | Active comparator | Device: Yin and Yang Regulating Moxibustion1.The acupoints will be selected as Zhongwan, Guanyuan, Sanyinjiao (double).The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.Light one end of the moxa stick and hang it about 2-3cm above the skin, taking the patient's local skin redness and conscious warmth as the degree. Moxa-box moxibustion will be used for 20 minutes each treatment, once every other day, 3 times a week, for a total of 12 weeks of treatment, and 12 weeks of follow-up after the treatment. 2.Lifestyle modification:It will be performed as the same as the Yin and Yang Regulating Moxibustion group. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who meet the diagnostic criteria for menopausal syndrome and obesity;
- Patients with BMI≥25 and waist circumference≥80cm;
- Female patients between 40-60 years old;
- Have not taken any hormone drugs or weight loss related drugs in the past 3 months;
- Sign the informed consent and voluntarily accept the intervention methods of this project.
Key exclusion criteria (7 listed)
- Unexplained vaginal bleeding, or unnatural menopause;
- Have used hormone replacement therapy or other drugs related to this disease in the past 3 months;
- Combined with serious organic diseases, endocrine diseases, heart, liver and kidney, and respiratory diseases;
- Secondary obesity caused by hypothalamic lesions, hypothyroidism, glucocorticoid therapy, etc.;
- Combined with organic uterine diseases, such as polycystic ovary syndrome, malignant tumors, severe cervical erosion, after total hysterectomy, etc.;
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 |
|---|---|---|
| Yin and Yang Regulating MoxibustionBefore making Wenyang Yishen moxibustion, the width and length of the patient's moxibustion site were evaluated by the same body measurement method. Take about 700g of fresh ground ginger with moderate dryness and wetness, and place it on the treatment towel to make a round cake with a diameter of about 20cm and a thickness of about 2.5cm. Spread 25g of moxa moxa with a diameter of about 18cm on top of ginger and light it. When the bottom temperature reaches about 37 degrees, the door can be placed on the patient's waist for treatment. According to the patient's tolerance, the temperature should be controlled at 43-45 degrees. It is better to replace the moxa biscuit every time when the moxa biscuit is burned for about 10 minutes. The patient's local skin has a slight redness and burning. The moxibustion time is 60 minutes. Peiyuan Guben moxibustion is centered on Shenque, and the operation is the same as that of WenYang and Yishen moxibustion. | Device | Mild Moxibustion, Yin and Yang Regulating Moxibustion |
Primary outcome
Waist circumference
Time frame: Week 0, 4, 8, 12, 18and24.
The change in waist circumference compared to the baseline.
11 secondary outcomes
BMI(weight/height²)
Time frame: Week 0, 4, 8, 12, 18and24.
Weight(WG)
Time frame: Week 0, 4, 8, 12, 18and24.
Hip circumference(HC)
Time frame: Week 0, 4, 8, 12, 18and24.
Waist-to-hip ratio(waist circumference/hip circumference)
Time frame: Week 0, 4, 8, 12, 18and24.
Body fat percentage(F percent)
Time frame: Week 0, 4, 8, 12, 18and24.
The syndrome score of Traditional Chinese Medicine
Time frame: Week 0, 12and24.
The impact of weight on quality of life (IWQOL)-Lite scale
Time frame: Week 0, 12and24.
Modified Kupperman score
Time frame: Week 0, 12and24.
The MOS Item Short from Health Survey（SF-36).
Time frame: Week 0, 12and24.
Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).
Time frame: Week 0 and 12.
Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).
Time frame: Week 0 and12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Derived from this study: PubMed 35966744Yu B, Huang W, Zhang Y, Wang J, Xia C, Zhang Y, Xia H, Hu Y, Rao Y, Zhou Z. Efficacy and Safety of Moxibustion for Menopausal Obesity: A Multicentre, Randomized, Controlled Trial Protocol. Evid Based Complement Alternat Med. 2022 Aug 4;2022:9255017. doi: 10.1155/2022/9255017. eCollection 2022.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yin and Yang Regulating Moxibustion in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine at 2 sites 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 7 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Zhong-Yu Zhou, professor (18672308659 ext. 86, 2209447940@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: Week 0, 4, 8, 12, 18and24.). 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 NCT04943705, 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 29 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.