Efficacy and safety of 3% Arjunoglucoside on individuals who are at higher risk of cardiovascular disease - A randomized, double-blind, placebo controlled clinical study.

SamiSabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1.Male and female of 35 to 65 years old, both inclusive.
•2.Atherogenic index of plasma > 0.1
•3.BMI >= 30 kg/m2
•4.Total cholesterol > 200mg/dL; LDL > 150mg/dL; Serum Triglyceride > 150mg/dL; HDL Cholesterol < 40;
•5.Blood Pressure - Systolic 140-159 mm Hg and/or diastolic 90-99 mm Hg ( Grade 1 hypertension)
•6.Females with child-bearing potential who agree to use barrier method of contraception throughout the study period.
•7.Patients must be willing to come for regular follow-up visits.
•8.Willing to sign informed consent.

•1.Pregnant or lactating or female having the intention to be pregnant within next three months.
•2.Do not agree to stop Smoking & Alcohol intake during the study duration
•3.BMI > 40 kg/m2
•4.Subjects having history of diabetes (Type I or Type II)
•5.Fasting Blood Glucose >= 126 mg/dl and HbA1c >= 7%.
•6.Patients undergoing any other regimen apart from the prescribed standard management
•7.Having untreated BP of systolic < 140 mmHg & >= 160 mmHg and diastolic < 90 mmHg & > 100 mmHg.
•8.Patients having Lactose intolerance.
•9.Liver dysfunction (serum bilirubin > 1.5 times upper limit of normal or serum transaminase > 2 times upper limit of normal
•10.Patients having neurodegenerative & major psychiatric disorders
•11.Subjects with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR of 60 or less)
•12.A history of significant multiple and/or severe allergies or anaphylactic reactions
•13.Patient with known history of hypersensitivity to the investigational product
•14.Patient has participated in any clinical trial within last 3 months
•15.Any other condition which the Principal Investigator thinks may jeopardize the study

发起方

SamiSabinsa Group Limited