Observation on Obesity Undergoing SOWI

Study Overview
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Brief Summary
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Obesity becomes a worldwide chronic health problem, including China. Meta-analyses showed in recent years anti-obesity effects of Chinese herbal therapy (CHT) in overweight and obese patients. However, there are still few observational studies on its effect in patients undergoing CHT more than 6 months, or on its safety. This is a mono-centric, prospective study conducted at Shanghai Municipal Hospital of Traditional Chinese Medicine. Patients with body mass index ≥ 28 Kg/m2 and chartered by heat-dampness is consecutively recruited. All the patients will undergo an integrated SRXPY-based Obesity Wellness Intervention (lifestyle invention + XRXP granule). Patients will be instructed by Traditional Chinese Medicine(TCM) practitioner and nutritionist. They will be investigated every 3 months, until 2 years after enrollment. The study will test anti-obesity effect and safety of the integrated obesity wellness intervention, and test changes of appetite, health-related quality of life, bio markers as well.

Detailed Description
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Obesity is a worldwide problem to public health, with a prevalence rate of 12.4% according to recent studies. It is associated with a series of chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver, polycystic ovary syndrome, cancer, and so on. Many publications reported Chinese herbal therapy as an effective anti- obesity management. However, there are still few observational studies on its effect in patients undergoing Chinese herbal therapy more than 6 months, or on its safety. This is a mono-centric, prospective study conducted at Shanghai Municipal Hospital of Traditional Chinese Medicine. Patients with body mass index ≥ 28 Kg/m2 will be consecutively recruited in out-patient clinic of the department of endocrinology or nutrition. Another important including criteria is that each subject is supposed to be chartered by heat-dampness pattern in TCM. Patients will undergo an integrated SRXPY-based obesity wellness intervention(SOWI). They will report weekly diet, daytime physical activities and sleeping time, by means of WeChat and Electrical bracelet. Meanwhile, TCM practitioner and nutritionist will be involved in helping them. The integrated obesity wellness intervention is based on lifestyle invention and XRXP granule. XRXP granule is composed of several herbs, such as Huang Qin (Baical Skullcap Root), Zi Cao (Root of Sinkiang Arnebia), Hu Zhang (Rhizoma Polygoni cuspidata), Cang Shu (Atractylodis Rhizoma), He Ye (Lotus Leaf), etc. Some components have been found, which can ameliorate serum concentrations of glucagon-like peptide-1 by stimulating gut taste receptors in db/db mice. Also, XRXP granule showed anti-obesity effects (reduction of body weight, body mass index and waist circumstance) in a 12-week pilot study on obese patients. In this observational study, patients will be investigated every 3 months, until 2 years after enrollment. We will not only test the effect and safety, but test changes of appetite, health- related quality of life, bio markers as well.

Official Title
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The Observation Study on Obesity Cohort Undergoing SRXPY-based Obesity Wellness Intervention

Conditions
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Obesity, Traditional Chinese Medicine

Intervention / Treatment
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* Combination Product: SRXPY-based Obesity Wellness Intervention(SOWI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ·age ranged from 16-70 years old body mas index over 28kg/m2 Exclusion Criteria: secondary cause of obesity such as hypothalamic obesity, cushing syndrome, and hypophysis dysfunction, etc. pregnancy or lactation significant dysfunction of heart, liver, kidney and systemic organs (NYHA Class III or IV; alanine aminotransferase(ALT) and / or aspartate aminotransferase(AST) ≥ 5 times the normal upper limit; glomerular filtration rate< 60(ml/min) or with malignant tumor body weight fluctuated by more than 5 kg in the last 3 months with drug abuse or alcohol addiction with serious mental and neurological disorders blood pressure ≥ 180/110 mmHg, or malignant hypertension organic and systemic diseases intolerant of herb

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SOWI Group<br>Obesity Cohort undergoing SRXPY-based Obesity Wellness Intervention | Combination Product: SRXPY-based Obesity Wellness Intervention(SOWI)<br>* It is an integrated obesity wellness intervention, composing of lifestyle invention and Chinese herbal therapy (XRXP granule, twice daily, oral administration). XRXPY is made in accordance with standard procedures. Participants will be instructed by TCM practitioner and educated by nutritionist. They will perform diet self-report by WeChat, recording daytime physical active steps and all-day sleeping time by electric bracelet. All the participants will be followed every 2-4 weeks by means of out-patient clinic, phone call or WeChat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Body Weight | Measuring body weight at the required time point | 2021-2027 | 
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Measuring body weight at the required time point | 2021-2027 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve ≥10% body weight reduction | Measuring body weight at the required time point | 2021-2027 | 
| Percentage of participants who achieve ≥15% body weight reduction | Measuring body weight at the required time point | 2021-2027 | 
| Change in waist circumference | Measuring waist circumference at the required time point | 2021-2027 | 
| Change in glycosylated hemoglobin A-1c(Hba1c) | Measuring Hba1c at the required time point | 2021-2027 | 
| Change in fasting blood glucose | Measuring fasting blood glucose at the required time point | 2021-2027 | 
| Change in Three-Factor eating questionnaire(TFEQ-R21) | Investigating TFEQ-R21 at the required time point | 2021-2027 | 
| Change in food craving questionnaire-trait(FCQ-T) | Investigating FCQ-T at the required time point | 2021-2027 | 
| Change in Impact of weight quality of life-lite(IWQOL-Lite) | Investigating IWQOL-Lite at the required time point，higher scores indicate better quality of life on the IWQOL-Lite(0-100). | 2021-2027 | 
| Change in the medical outcomes study item short from health survey-short from(SF-36) | Investigating SF-36 at the required time point，higher scores indicate better quality of life on the SF-36(0-100). | 2021-2027 | 
| Change in cholecystokinin(CCK) | Measuring CCK in serum at the required time point | 2021-2027 | 
| Change in bile acid | Measuring bile acid in serum and feces at the required time point | 2021-2027 | 
| Change in peptide YY(PYY) | Measuring PYY in serum at the required time point | 2021-2027 | 
| Change in ghrelin(GHRL) | Measuring GHRL in serum at the required time point | 2021-2027 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Traditional Chinese medicine, SRXPY-based Obesity Wellness Intervention