A Randomized, Double Blind, Placebo controlled, Parallel Group Clinical Study to evaluate Efficacy and Safety of a Novel herbal composition JOFP-002 in subject with metabolic syndrome.

Jeeva Organic Private Limited1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年12月31日最近更新: 2025年12月19日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Metabolic syndrome is a condition that includes high blood sugar, increased waist size, high blood pressure, and abnormal cholesterol levels. This study is being conducted to evaluate the effectiveness and safety of a new herbal formulation, JOFP-002, in people with metabolic syndrome.

Participants will be randomly assigned to receive either JOFP-002 or a placebo. The study will assess changes in blood sugar, cholesterol, blood pressure, body weight and waist circumference. Safety will be monitored through regular health check-ups and laboratory tests.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Male or female subjects between 18 to 65 years of age Ability to understand the risks/benefits of the protocol Female subjects of childbearing potential must be using a medically acceptable form of birth control.
•Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy Confirmed diagnosis of metabolic syndrome as per ATP-III guidelines.
•This includes the presence of at least 3 or more of the following 5 factors: (As per modified NCEP ATP III guidelines-specific for South Asia) Including Abdominal waist circumference greater than 90 (males), greater than 80 cm (females) and Increased blood pressure (greater than or equal to 130 per 85 mm Hg) Serum triglycerides greater than or equal to 150 mg per dL Serum HDL cholesterol less than 40 mg per dL (males), less than 50 mg per dL (females) Elevated fasting blood glucose greater than or equal to 100 mg per dL Subjects agree to maintain the activity dairy If Former smoker (previously smoked greater than or equal to 10 cigarettes per day for at least 1 year, cessation for at least 6 months Willing to give written informed consent and willing to comply with trial protocol.

排除标准

未提供

研究者

发起方

Jeeva Organic Private Limited

申办方类型

Pharmaceutical industry-Indian

责任方

Principal Investigator

主要研究者

Dr P Akash Kumar

Chennai Meenakshi Multispeciality Hospital

研究点 (1)

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