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

Dabur India Limited0 个研究点目标入组 110 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Subjects of either sex (Male and Female) in the age group of 18 to 65 years, both inclusive.
•Subjects with LDL-C greater or equal than 130 at the time of screening.
•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.

•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.
•Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
•Known case of Anorexia Nervosa or Bulimia nervosa
•Chronic alcoholics / Alcohol Abuse
•Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
•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.
•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.
•Subjects currently participating in any other Clinical study
•Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment

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