The Efficacy and Safety of Puerarin in Obesity Treatment

Официальное название

Randomized Controlled Trial of Puerarin for Obesity Treatment

Обзор

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.

Вмешательства

• Препарат 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).
• Препарат 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). Blindin

Первичные конечные точки

• Body weight [Срок оценки: 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 [Срок оценки: 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]) [Срок оценки: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day]
• Fecal Lipids [Срок оценки: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.]

Вторичные конечные точки (6)

• Blood Glucose [Срок оценки: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day]
• Basal Metabolic Rate [Срок оценки: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.]
• Gut Hormones [Срок оценки: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.]
• Insulin level [Срок оценки: 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 [Срок оценки: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).]
• C-Peptide [Срок оценки: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06968208 · Ruijin2025-177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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