An Open Label, Randomized, Comparative (active), Multi-center, prospective clinical study to evaluate Efficacy and Safety of AYRL Capsule in patients suffering from Dyslipidemia

Welex Laboratories Pvt Ltd0 个研究点目标入组 0 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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•1.Subjects diagnosed of Dyslipidemia (LDL-C between 130 and 190 mg/dl or Triglycerides between 150 and 500 mg/dL or TC >= 240 mg/dl but not more than 400 mg/dl) who are not taking any Hypo-lipidemic agents including Statins
•2.Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
•3.A urine pregnancy test will be required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
•4.Female subjects who agree to avoid pregnancy during the study and one month after the end of the study by using reliable method of contraception.
•5.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

•1.Subjects with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations or any significant cardiovascular event within 6 months prior to screening visit.
•2.Subjects with history of gastric or peptic ulcer within 3 months prior to screening visit.
•3.Subjects with uncontrolled diabetes mellitus and uncontrolled hypertension
•4.Subjects with medical history of pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, or primary biliary cirrhosis within last six months.
•5.Subjects of Hypothyrodism with TSH levels of >10mg% will be excluded
•6.Subjects with liver dysfunction as indicated by a serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) level of > 1.5-times of upper limit of normal range, or clinical symptoms.
•7.Subjects with clinical significant renal dysfunction as per investigatorâ??s opinion
•8.Subjects having an active malignancy and tuberculosis.
•9.Subjects with history of chronic, contagious infectious disease, such as active tuberculosis or Hepatitis B or C or HIV.
•10.Use of any other investigational drug within 1 month prior to randomization
•11.Known hypersensitivity to ingredients used in study drugs
•12.Pregnant and Lactating females.
•13.Any other condition, which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.

发起方

Welex Laboratories Pvt Ltd