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observational study to evaluate the safety, efficacy and tolerability of VASOCLEAR syrup in patients with cardio vascular problems

An open-label, single-arm, non randomized observational study to evaluate the safety, efficacy and tolerability of VASOCLEAR syrup in patients with cardio vascular problems

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008818
Enrollment
40
Registered
2017-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- cardio vascular problems

Interventions

Intervention1: VASOCLEAR SYRUP: VASOCLEAR SYRUP contains Extracts made from Arjuna, Garlic, Ginger, Grape seed, Citrus, Rauvolfina serpentine etc. etc. which are natural products used for centuries in

Sponsors

RATHNA BIOTECK PvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactBG Reddy

RATHNA BIOTECK Pvt.Ltd

rathnabiotec@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026