A Three Arm, Randomized, Open Label, Active-Controlled, Clinical Study to Evaluate Efficacy and Safety of Saunfbhara (PP/JLN/105) in the Management of Dyslipidemia & Body Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- 1.Change in LDL-C level at the end of study (12 weeks)
研究概览
简要总结
Adult subjects of either sex with age between 18-65 years (both inclusive) will be screened for eligibility criteria. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. Subject’s Prakruti evaluation will be done. If the subject meets the inclusion and exclusion criteria subject he/she will be randomized as per computer generated randomization list. Subject will be assigned to either of the three study groups. Subject will be asked to take the assigned study product in the respective dose for a period of 12 weeks. Subjects will be asked to follow up after every 3 weeks At the end of the study, all subjects will undergo Laboratory investigations and ECG. Physician’s overall assessment of efficacy and safety will be done at the end of the study. Subject’s clinical examinations including vitals like Pulse, Respiration, Temperature and Blood Pressure will be checked at baseline and thereafter every follow up visit. Adverse events will be recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects of either sex (Male and Female) in the age group of 18 to 65 years, both inclusive.
- •â€¢Subjects with LDL-C greater or equal than 130 at the time of screening.
- •â€¢Subjects with BMI greater or equal than 25 •Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
排除标准
- •â€¢Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II •Subjects who have Diet with excess cholesterol, saturated fat or calories •Subjects with uncontrolled Hypothyroidism or Hyperthyroidism •Known cases of Severe/Chronic Hepatic or Renal disease •Known subject of any active malignancy.
- •â€¢Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
- •â€¢Known case of Anorexia Nervosa or Bulimia nervosa •Chronic alcoholics / Alcohol Abuse •Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
- •â€¢Subjects X- ray chest showing any active lesion of tuberculosis •Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
- •â€¢Subjects using any other investigational drug within 1 month prior to recruitment •Known hypersensitivity to any of the ingredients used in study drug •Pregnant and Lactating females.
- •â€¢Subjects currently participating in any other Clinical study •Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigator’s judgment.
结局指标
主要结局
1.Change in LDL-C level at the end of study (12 weeks)
时间窗: 12 weeks
2.Change in body weight at the end of study (12 weeks)
时间窗: 12 weeks
次要结局
- Change in LDL-C level at 6 weeks,Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC), High Density Lipoprotein (HDL), Body Weight, BMI, Waist circumference, Waist to hip ratio and EQ-5D Quality of Life (QOL) at 6 weeks and 12 weeks, Overall efficacy and safety of the study product as per the physician (CGI-I) at the end of study (12 weeks),Safety assessment by assessing adverse drug reactions, clinically significant abnormal laboratories values(6 and 12 weeks)