The Efficacy and Safety of Puerarin in Obesity Treatment

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

January 31, 2029

Study Completion Date

December 31, 2029

Conditions
Metabolic DiseasesObesity/Therapy
Interventions
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).

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.

Trial Locations (1)

200000

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER