NCT05122936Enrolling by invitation
Observation on Obesity Undergoing XOWI
The Observation Study on Obesity Cohort Undergoing XRXPY-based Obesity Wellness Intervention
Source: ClinicalTrials.gov · Last updated 22 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 24 Oct 2021
- Start date
- 30 Nov 2021
- Primary completion date
- 14 Nov 2026
- Lead sponsor
- Feng Tao
- Diseases
- Obesity
- NCT number
- NCT05122936
What you commit to
- Study type: Observational
- Planned participants: 500
- From 30 Nov 2021 to the primary completion date, 14 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- body weight fluctuated by more than 5 kg in the last 3 months with drug abuse or alcohol addiction
Other illness
- secondary cause of obesity such as hypothalamic obesity, cushing syndrome, and hypophysis dysfunction, etc.
- with serious mental and neurological disorders
- blood pressure ≥ 180/110 mmHg, or malignant hypertension
- organic and systemic diseases intolerant of herb
Lab values
- 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
Other
- pregnancy or lactation
Who the study is looking for
- ·age ranged from 16-70 years old body mas index over 28kg/m2
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Municipal Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.