observational study to evaluate the safety, efficacy andtolerability of VASOCLEAR syrup in patients withcardio vascular problems

Phase 4

• Conditions: Health Condition 1: null- cardio vascular problems

• Registration Number: CTRI/2017/06/008818
• Lead Sponsor: RATHNA BIOTECK PvtLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Subject of either sex aged between 18 â?? 65 years

Male and female outpatients between 18-75 Years of age.

Patients having i. LDL cholesterol >130mg/dl ,

Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl

Serum creatinine of <3.0mg/dl.

Willingness and able to give informed consent and comply with requirements for participation in the study.

Exclusion Criteria

Subject who is pregnant or Lactating

Any of the following is regarded as a criterion for exclusion from the study:

History of serious adverse effect or hypersensitivity reactions to the medication used in the treatment of subjects in any arm of the study.

Pregnant women and breast feeding

History of malignancy

Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT greater than1.5times ULN.

Uncontrolled serum CK greater than3 times ULN

Serum creatinine greater than 2.5mg/dl

Participation in another investigational drug trial within the previous 4 weeks diabetic foot ulcers in the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of Lipid Modification (LDL cholesterol lowering and HDL cholesterol raising) with VASOCLEAR syrup (3 to 4 TSP each) each time in the empty stomach and half an hour before going to bed. To evaluate the Blood Pressure Lowering with VASOCLEAR syrup (3 to 4 TSP each) each time in the empty stomach and half an hour before going to bedTimepoint: To evaluate the effects of Lipid Modification (LDL cholesterol lowering and HDL cholesterol raising) with VASOCLEAR syrup (3 to 4 TSP each) each time in the empty stomach and half an hour before going to bed. To evaluate the Blood Pressure Lowering with VASOCLEAR syrup (3 to 4 TSP each) each time in the empty stomach and half an hour before going to bed

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of Deep vein thrombosis (DVT) (Blood clotting disorders) Thickening, shrinking and hardening and Arteries Tolerability will be assessed based on the adverse effects as evaluated by the investigatorTimepoint: Base line and Week 6