An Open Label Clinical Study to Evaluate the Efficacy and Safety BerBeristaTM on Obesity Management in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean change in body Weight and BMI from baseline to different study visits
研究概览
简要总结
This open-label, interventional clinical study is designed to evaluate the efficacy and safety of BerBerista (500 mg twice daily) in the management of obesity among 20 healthy volunteers over a 90-day treatment period. The primary objectives are to determine the percentage change in body weight and improvement in Body Mass Index (BMI) compared to baseline. Secondary objectives include assessing changes in anthropometric measurements (waist circumference and waist-to-hip ratio), monitoring laboratory parameters (CBC, LFT, RFT, RBS, lipid profile), and recording adverse events throughout the study. Eligible participants are 18 to 50 years old with a BMI 26 to 32, willing to adhere to a healthy diet, maintain a 30-minute walking exercise program five days per week, and comply with study procedures, including maintaining dietary and activity diaries. Individuals with major systemic illnesses, metabolic disorders (such as diabetes or thyroid disease), cardiovascular conditions, or recent investigational drug use will be excluded. The study consists of four visits: Screening/Baseline at Day 1, telephonic follow-ups at Day 30 and Day 60, and an end-of-study visit at Day 90. Key assessments include weight, BMI, anthropometric measurements, laboratory safety tests, and adverse event monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex between 18 to 50 years of age; Subject with BMI range 26-32; Ability of the subject to understand the risks and benefits of the study; Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, or double-barrier and have a negative pregnancy test at the Screening Visit.
- •Female subjects of non-childbearing potential must be amenorrhoeic for at least one year or had a hysterectomy and/or bilateral oophorectomy; Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) with the scheduled timing per week during the study period; Subject agrees to consume a healthy vegetarian or non-vegetarian diet; Subject should be available for duration of study period (three months); Subjects agree to come to site in fasting state for their weight measurements and other laboratory parameters examination in all the scheduled visits; Subject using other therapies for weight management including physiotherapy or occupational therapy agrees to discontinue these therapies during this study; Subject agrees not to start any new therapies for weight loss during the study period; Subjects agree to maintain the activity dairy; Willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •Subjects suffering from intractable obesity, has defined weight limits, or have experienced any recent, unexplained weight loss or gain; Having history of underlying inflammatory arthropathy, septic arthritis, gout, inflammatory joint disease, joint fracture, or rheumatoid arthritis, thyroid disease, liver, or kidney diseases, and hypertension; Having history of asthma, cardiovascular diseases, coagulopathies, diabetes (Type I or Type II); History of high alcohol intake (2 standard drinks per day); History of psychiatric disorder that may impair the ability of subjects to provide written informed consent and increase the risk of adverse events or interfere with study assessments; Subjects, who are pregnant, breast feeding or planning to become pregnant during the study; Immunocompromised subjects or subjects with steroids or immunomodulators; Patients of vulnerable group (lactating mother, handicapped, seriously ill or mentally challenged); Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures; Participated in any investigational study medication within thirty (30) days prior to screening; Known allergy to compounds of investigational product.
结局指标
主要结局
Mean change in body Weight and BMI from baseline to different study visits
时间窗: At baseline, Day 30, Day 60 and Day 90
次要结局
- Change from the baseline in waist circumference, waist to hip ratio , Complete Blood Count, Liver Function Test (SGOT), Renal Function Test (Creatinine), Random Blood Sugar, Total Cholesterol and Triglyceride, Incidence of treatment-related adverse events(Day 1 to Day 90)
研究者
Dr Giri Raja KV
Rajalakshmi Hospital and Research Center