NCT06968208Not yet recruitingPhase 2
The Efficacy and Safety of Puerarin in Obesity Treatment
Randomized Controlled Trial of Puerarin for Obesity Treatment
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This randomized controlled trial aims to evaluate the therapeutic efficacy of puerarin intervention in weight management and metabolic regulation among obese populations. The study will systematically address two primary endpoints: 1) The capacity of puerarin to induce clinically significant body weight reduction in individuals with BMI ≥30 kg/m²; 2) Its modulatory effects on postprandial lipid metabolism as measured by serum lipids and quantitative fecal lipid excretion analysis. Secondary outcomes focus on puerarin's pleiotropic effects, including continuous glucose monitoring-derived glycemic parameters and indirect calorimetry-assessed resting metabolic rate. Secondary exploratory objectives include investigating puerarin's potential mechanisms of action through continuous glucose monitoring and indirect calorimetry measurements to assess glycemic variability and resting energy expenditure, respectively. Participants will be randomized into two parallel groups: the intervention group receiving daily oral puerarin injection (75 mg/day, dissolved in 100 mL of 0.9% sodium chloride solution) and the control group receiving matched blank 100 mL of 0.9% sodium chloride solution, both administered double-blind for 6 consecutive months. Primary efficacy endpoints (body weight, waist circumference, lipid profile) and safety monitoring (adverse events, hematological/ biochemical parameters) will be assessed at baseline, 1, 3, and 6 months post-intervention.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 5 May 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Ruijin Hospital
- Diseases
- Obesity
- NCT number
- NCT06968208
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 1 Aug 2025 to the primary completion date, 31 Jan 2029
- 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
- Use of weight-control medications (e.g., metformin, GLP-1 receptor agonists, orlistat), corticosteroids (oral/IV/IM/non-oral systemic/intra-articular), or metabolic-interfering drugs/supplements within 3 months prior to screening or during the trial.
- Use of traditional Chinese medicines or herbal products for weight management within 3 months prior to screening or during the trial.
- Gastrointestinal surgery within 1 year (excluding appendectomy/hernia repair) or major non-GI surgery within 6 months.
- Participation in other clinical trials within 3 months prior to screening.
Other illness
- Secondary causes of obesity (e.g., monogenic obesity, Cushing's syndrome, drug-induced obesity).
- History of common nutrient allergies (e.g., gluten, milk, eggs, plant-derived proteins).
- History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.
- Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).
- Known hypersensitivity to trial drug components or history of severe drug allergies.
- Severe cardiac disorders (e.g., congenital/rheumatic heart disease, cardiomyopathy \[NYHA ≥III\], coronary stenting).
- History of malignancies (treated/untreated), regardless of recurrence status.
- Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea/constipation).
- Any condition deemed unsuitable by investigators.
Lab values
- Severe infections, severe anemia (Hb \<8 g/dL), or neutropenia (ANC \<1.5×10⁹/L).
- Hepatic/renal dysfunction: ALT/AST ≥2.5×ULN, serum creatinine \>ULN, or eGFR \<60 mL/min/1.73m² (MDRD formula).
Other
- Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.
- Active substance/alcohol abuse.
- Hyperthyroidism or hypothyroidism.
Who the study is looking for
- Aged 18-60 years (inclusive), any gender.
- Obesity (BMI ≥30.0 kg/m²).
- With or without obesity-related metabolic comorbidities (e.g., type 2 diabetes, hypertension, dyslipidemia, hyperuricemia).
- No prior use of weight-control, glucose-lowering, or lipid-modifying medications.
- Stable weight (\<3% fluctuation) and lifestyle for ≥1 month prior to screening.
- Fully informed of trial objectives, procedures, risks, and benefits; voluntarily signed informed consent form.
Age in the registry: 18 years to 60 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 |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of 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.