A Prospective, Randomized, Single blind, Four Arms, Placebo Controlled, Clinical Study to Evaluate the Efficacy and Safety of Black Cumin Seed Extract (NigellinÃ?Â®) in the Management of Metabolic Syndrome

Sami Sabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Adult male and/or female participants between 18 to 65 years (both inclusive).
•2.Newly diagnosed Type II Diabetes, having high blood sugar with fasting glucose Ã¢â?°Â¥ 100 mg/dL
•3.Hypertension with systolic blood pressureÃ¢â?°Â¥140 mm Hg or diastolic blood pressureÃ¢â?°Â¥90 mm Hg.
•4.Patients with any one of the two criteriaÃ¢â?¬•s as below
•Fasting total triglycerides Ã¢â?°Â¥150 mg/dL.
•HDL cholesterol: < 40 mg/dL (Male), < 50 mg/dL (Female).
•5.Agree to follow basic physical activity like walking for 30 min for 5 days in a week.
•6.Participants willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol.
•7.Willing to sign informed consent.

•1.Pregnant and lactating female and having the intention to be pregnant within next three months.
•2.Body Mass Index (BMI) > 35 kg/m2.
•3.Females with reproductive potential who do not agree to use barrier method of contraception throughout the study period.
•4.History of Smoking & Alcohol intake (within 3 months before screening).
•5.On any special diet.
•6.On special physical training regime like intense workout or gym.
•7.Diagnosed with Type 1 diabetes.
•8.With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance.
•9.Use of any lipid-lowering therapies in the past 3 months.
•10.Participants with HbA1c > 7%.
•11.Participants with history of clinically significant or diagnosed with thyroid disorder (hypo or hyper), gastrointestinal, cardiovascular, haematological, hepatic (SGOT or SGPT levels > 3 Upper Limit of Normal), renal (serum creatinine Ã¢â?°Â¥ 1.3 mg/dl), respiratory, active malignancy or genitourinary abnormalities or diseases.
•12.A history of significant multiple and/or severe allergies or anaphylactic reactions.
•13.Participants with known history of hypersensitivity to the investigational product.
•14.Participants who has participated in any clinical trial within last 3 months.
•15.Any other condition which the Principal Investigator thinks may jeopardize the study.

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