Clinical trial

Observation on Obesity Undergoing XOWI

Invitation only · Not applicable · 1 countries · Registry ID NCT05122936

Invitation onlyNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Traditional Chinese Medicine

Full registry criteria

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

Treatments and study arms

XRXPY-based Obesity Wellness Intervention(SOWI)

Combination Product

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.

Primary outcomes

Mean Percent Change in Body Weight2021-2027

Measuring body weight at the required time point

Percentage of Participants who Achieve ≥5% Body Weight Reduction2021-2027

Measuring body weight at the required time point

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Shanghai Municipal Hospital of Traditional Chinese Medicine🇨🇳 Shanghai, Shanghai Municipality, China

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