The Efficacy and Safety of Puerarin in Obesity Treatment

Randomized Controlled Trial of Puerarin for Obesity Treatment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Diseases; Obesity/Therapy
• Intervention / Treatment: Drug: Puerarin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiqiu Wang, PhD, Principal Investigator; Phone Number: +86-153-0048-3751; Email: wangjg@shsmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Puerarin Group; Diet Stabilization (Days 0-3): Standardized high-fat isocaloric diet (25% carbs, 58% fat, 17% protein) to normalize baseline metabolic status.; Intervention Period (6 months): Participants will receive oral administration of 75 mg puerarin dissolved in 0.9% sodium chloride solution, taken 30 minutes before lunch	Drug: Puerarin; 75 mg of puerarin injection, dissolved in 0.9% sodium chloride solution. The puerarin injection is manufactured under Good Manufacturing Practice (GMP) conditions by [Harbin Medisan Pharmaceutical Co., Ltd.], with identical appearance, size, and packaging to the blank 0.9% sodium chloride solution to ensure blinding. Stability testing confirms integrity under standard storage conditions (25°C, 60% RH).
Placebo Comparator: Placebo Group; Diet Stabilization (Days 0-3): Standardized high-fat isocaloric diet (25% carbs, 58% fat, 17% protein) to normalize baseline metabolic status.; Intervention Period (6 months): Participants will receive oral administration of one matching blank 0.9% sodium chloride solution, taken 30 minutes before lunch. Blank injections are identical in appearance, taste, and packaging to the active puerarin injections but contain no active ingredients.	Drug: Placebo; 0.9% sodium chloride solution formulated to match the appearance, size, and taste of the active puerarin solution, with no other active pharmaceutical ingredients. 0.9% sodium chloride solution is manufactured under identical Good Manufacturing Practiceconditions by [Shijiazhuang No.4 Pharmaceutical Co., Ltd.] and changed to the same batch processes and packaging as the intervention group. Stability testing confirms equivalent integrity under standard storage conditions (25°C, 60% RH). Blinding is ensured through indistinguishable outer packing characteristics and labeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight will be measured to the nearest 0.1 kg using a calibrated digital scale under standardized conditions: participants in lightweight clothing (hospital gown), barefoot, and after an overnight fast (≥8 hours).	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Body Fat Percentage	Body fat percentage will be quantified via bioelectrical impedance analysis (BIA, InBody 770®).	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Serum Lipid Profile (Total Cholesterol [TC], Triglycerides [TG])	Total Cholesterol (TC): Measured via cholesterol oxidase-peroxidase method, traceable to CDC reference standards. Triglycerides (TG): Quantified using glycerol-3-phosphate oxidase method with correction for free glycerol. The blood samples will be collected before and 2 hours after meals.	Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
Fecal Lipids		Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose	The blood samples will be collected after overnight fasting and 2 hours after meals.	Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
Basal Metabolic Rate	Basal metabolic rate will be measured via indirect calorimetry using a validated metabolic cart under strictly standardized conditions: participants in a fasting state (≥12 hours overnight), resting supine in a thermoneutral environment (22-24°C), with 30 minutes of pre-measurement rest and avoidance of caffeine or vigorous activity for 24 hours prior.	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Gut Hormones	Like ghrelin, cholecystokinin (CCK), Glucagon-like peptide-1 (GLP-1), Peptide YY (PYY)	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Gut Microbiome Metagenomics		Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).
Insulin level	The blood samples will be collected after overnight fasting(>8 hors).	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
C-Peptide	The blood samples will be collected after overnight fasting(>8 hors).	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: May 5, 2025
• First Posted (Actual): May 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Puerarin; Intestinal Lipid Absorption; Dorsal Motor Nucleus of Vagus (DMV)
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Metabolic Diseases; Vasodilator Agents; Puerarin
• Other Study ID Numbers: Ruijin2025-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No