Clinical study on AYRL Capsule in patients with elevated cholesterol level

Phase 2/3

Completed

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2019/07/020229
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

It is an open label, randomized, comparative (active), multi-center,prospective study to evaluateefficacy and safety of AYRL Capsule in patients suffering fromDyslipidemia. The study will beconducted at two sites in India. As per computer generated randomization list,subjects will be randomized to either of the two groups i.e. AYRL Capsules (2 capsules twice a day) or Atorvastatin(10 mg once a daily) for 90 days. The primary objectives of the study will be tocompare change in LDL levels over three months of thestudy treatment between the groups and to compare change in serum triglycerides and total Cholesterol levels between the groups. The secondary objectives of the study will be to comparemonthly changes in Serum High density lipoprotein (HDL), Very lowdensity lipoprotein (VLDL), TC/ HDL ratio, LDL/HDL ratio over three months of studytreatment between the groups, changes in Cardiacbiomarkers [Hs-CRP, Homocysteine, Lipoprotein (a), ApolipoproteinA1 (Apo A1),Apolipoprotein B (Apo B), Apo B / Apo A1 ratio] after 90 days of treatmentbetween the groups,  to compare monthly changes in weight, BMI,waist circumference, Hip Circumference, waist: Hip ratio Basal Metabolic Rate(BMR), Body fat percentage (Instrumental evaluation), total body water, leanbody mass (LBM), Neck circumference, Upper mid arm circumference, calfcircumference between the groups, to assess overall change by investigator and by subject between thegroups and to assess tolerability of study treatments by assessing ADRs, vitals andassessment of safety laboratory investigations.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-19
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.Subject’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.

Exclusion Criteria

• 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 investigator’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Comparative change in Low density Lipoprotein (LDL) levels after three months of treatment between the groups	Day -7, Day 45, Day 90
2.Comparative change in Serum Triglycerides and Total Cholesterol levels after 90 days of treatment between the groups	Day -7, Day 45, Day 90

Secondary Outcome Measures

Name	Time	Method
1.Comparative changes in HDL, VLDL, TC/ HDL ratio, LDL/HDL ratio between the groups	2.Changes in Cardiac biomarkers between the groups

Trial Locations

Locations (3)

Ayurved Seva Sanghs Ayurved Mahavidyalaya; 🇮🇳 Nashik, MAHARASHTRA, India

S.D.M. College of Ayurveda; 🇮🇳 Udupi, KARNATAKA, India

Sadhana Diabesity Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Ayurved Seva Sanghs Ayurved Mahavidyalaya

🇮🇳Nashik, MAHARASHTRA, India

Dr Shishr Pande

Principal investigator

9420830818

shishir.nsk@gmail.com