The Efficacy and Safety of Puerarin in Obesity Treatment

Launched by RUIJIN HOSPITAL · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called puerarin to see if it can help people with obesity lose weight and improve their metabolism. The researchers are looking for adults aged 18 to 60 who have a body mass index (BMI) of 30 or higher, which classifies them as obese. Participants can have other health issues related to obesity, like type 2 diabetes or high blood pressure, but they shouldn’t have taken any weight-loss or diabetes medications recently.

During the trial, participants will be randomly assigned to either receive puerarin or a placebo (a solution that looks the same but has no active ingredients) for six months. They will have regular check-ins to monitor their weight, waist size, and other health markers. This study is still in the planning stages and is not yet recruiting participants. If you or someone you know is interested in participating, it’s essential to be aware of the eligibility criteria and any potential health risks that could exclude someone from joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-60 years (inclusive), any gender.
• • 2. Obesity (BMI ≥30.0 kg/m²).
• • 3. With or without obesity-related metabolic comorbidities (e.g., type 2 diabetes, hypertension, dyslipidemia, hyperuricemia).
• • 4. No prior use of weight-control, glucose-lowering, or lipid-modifying medications.
• • 5. Stable weight (\<3% fluctuation) and lifestyle for ≥1 month prior to screening.
• • 6. Fully informed of trial objectives, procedures, risks, and benefits; voluntarily signed informed consent form.
• Exclusion Criteria:
• • 1. Secondary causes of obesity (e.g., monogenic obesity, Cushing's syndrome, drug-induced obesity).
• • 2. History of common nutrient allergies (e.g., gluten, milk, eggs, plant-derived proteins).
• • 3. 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.
• • 4. Use of traditional Chinese medicines or herbal products for weight management within 3 months prior to screening or during the trial.
• • 5. History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.
• • 6. Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.
• • 7. Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).
• • 8. Severe infections, severe anemia (Hb \<8 g/dL), or neutropenia (ANC \<1.5×10⁹/L).
• • 9. Gastrointestinal surgery within 1 year (excluding appendectomy/hernia repair) or major non-GI surgery within 6 months.
• • 10. Active substance/alcohol abuse.
• • 11. Known hypersensitivity to trial drug components or history of severe drug allergies.
• • 12. Severe cardiac disorders (e.g., congenital/rheumatic heart disease, cardiomyopathy \[NYHA ≥III\], coronary stenting).
• • 13. Hyperthyroidism or hypothyroidism.
• • 14. History of malignancies (treated/untreated), regardless of recurrence status.
• • 15. Hepatic/renal dysfunction: ALT/AST ≥2.5×ULN, serum creatinine \>ULN, or eGFR \<60 mL/min/1.73m² (MDRD formula).
• • 16. Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea/constipation).
• • 17. Participation in other clinical trials within 3 months prior to screening.
• • 18. Any condition deemed unsuitable by investigators.