Status:
NOT_YET_RECRUITING
The Efficacy and Safety of Puerarin in Obesity Treatment
Lead Sponsor:
Ruijin Hospital
Conditions:
Metabolic Diseases
Obesity/Therapy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
- History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.
- Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.
- Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).
- Severe infections, severe anemia (Hb \<8 g/dL), or neutropenia (ANC \<1.5×10⁹/L).
- Gastrointestinal surgery within 1 year (excluding appendectomy/hernia repair) or major non-GI surgery within 6 months.
- Active substance/alcohol abuse.
- 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).
- Hyperthyroidism or hypothyroidism.
- History of malignancies (treated/untreated), regardless of recurrence status.
- Hepatic/renal dysfunction: ALT/AST ≥2.5×ULN, serum creatinine \>ULN, or eGFR \<60 mL/min/1.73m² (MDRD formula).
- Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea/constipation).
- Participation in other clinical trials within 3 months prior to screening.
- Any condition deemed unsuitable by investigators.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06968208
Start Date
August 1 2025
End Date
December 31 2029
Last Update
May 21 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000