To study the effect of two drugs karanjadi vati and rosuvastatin tablet in patient with medovridhhi or high Cholesterol level.

Phase 2

Recruiting

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2019/08/020739
• Lead Sponsor: ASHISH KECHE

Brief Summary

**This is a randomized controlled open labelled parallel group clinical trial comparing the safety and efficaccy of karanjadi vati and rosuvastatin tablet.**

**Null hypothesis (H0):** Karanjadi Vati and Rosuvastatin Tablet are equally effective in the management of Medovriddhi W.S.R. to Hyperlipidaemia.

 **Alternative hypothesis (H1):** Karanjadi Vati and Rosuvastatin Tablet are not equally effective in the management of Medovriddhi w.s.r. to hyperlipidaemia.

In patient having multiple (+2) risk factor with 10 year risk of ≤10% & 10%-20% whose LDL cholesterol goals not achieve (≥160mg/dl & ≥130mg/dl respectively) after TLC Then in drug therapy, Will Karanjadi Vati 500 mg twice a day after food with koshna Jala and Rosuvastatin tablet 10mg once a day at bed time daily for 6 weeks are equally effective in the management of Medovriddhi with special reference to Hyperlipidaemia ?

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-19
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1)Patient having Serum LDL Cholesterol Level above 190mg/dl.
• 2. According to NCEP ATP III, Patient having multiple (+2) risk factor with 10 year risk of 10% of CHD whose LDL Cholesterol goals not achieve (≥160mg/dl) after 12 weeks Therapeutic lifestyle changes (TLC).
• 3)According to NCEP ATP III, Patient having multiple (+2) risk factor with 10 year risk of 10% to 20% of CHD whose LDL Cholesterol goals not achieve (≥130mg/dl) after 12 weeks Therapeutic lifestyle changes (TLC).

Exclusion Criteria

• 1)Patient with Multiple (+2) risk factor with 10 year risk 10% of CHD, who achieve the goal of LDL Cholesterol (≤160mg/dl) after TLC therapy.
• 2)Patient with Multiple (+2) risk factor with 10 year risk 10% to 20% of CHD, who achieve the goal of LDL Cholesterol (≤130mg/dl) after TLC therapy.
• 3)Pregnant women and lactating mothers.
• 4)Patients having history of Renal Disease, Liver Disease.
• 5)Patients having Recently 3 month history of Heart Failure or Stroke.
• 6)Patients having disorders like Carcinoma etc.
• anywhere in the body.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
value of LDL and signs and symptoms of hyperlipidaemia (Medovridhhi).	3 year

Secondary Outcome Measures

Name	Time	Method
SAFETY AND EFFICACY OF KARANJADI VATI AND ROSUVASTATIN TABLET	3 years

Trial Locations

Locations (1)

M. A. PODAR HOSPITAL; 🇮🇳 Mumbai, MAHARASHTRA, India

M. A. PODAR HOSPITAL

🇮🇳Mumbai, MAHARASHTRA, India

ASHISH KECHE

Principal investigator

8149921892

rajeashish09@gmail.com