Ayurvedic clinical trial on high cholesterol

Phase 3

Not yet recruiting

• Conditions: Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVRUDDHIH,

• Registration Number: CTRI/2023/11/059428
• Lead Sponsor: Vd Vaishali Shamrao Meshram

Brief Summary

The aim of study is toevaluate the clinical efficacy of Vatsakadi Vati with koshna jala in managementof Hyperlipidemia (Medovriddhi). To study the details of Vatsakadi Vati.To study in detailabout Medovriddhi according to Ayurvedic classics. To study in detail about Hyperlipidaemia according to modern medicine. The trial will be conductedon 50 patients showing anyone or more parameters of lipid profile i.e.,serum Cholesterol, serum Triglycerides, serum HDL, serum LDL, and serum VLDL, the range for the lipid profile will be decidedas per the American Journal of Lifestyle Medicine. Lipid profile will bechecked on the day patient enrollment. Medicine will be given for 60 days, atthe interval of 30 days patients will be assess the effect of therapy onobjective parameters. After 60 days of trial collected data of objectiveparameters will be statistically assess and conclusion will be drawn.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-27
• Study Start: 2023-11-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Patient irrespective of age, sex, religion etc.of Hyperlipidemia.
• 2.Patients with high blood lipid profile.Lipid profile showing any one or more of the following criteria was considered diagnostic of hyperlipidemia.
• 3.Patients with controlled Type 2 diabetes mellitus and hypertensive patients with blood pressure within the normal limits.
• 4.Obese Hyperlipidemic and Non-Obese hyperlipidemic Patients (BMI-18.50 to 40.00 kg/m2 as per New Updated WHO classification of BMI of 2004).
• 5.Patient having Serum Total Cholesterol Level >200mg/dl.
• 6.Patient having Serum LDL Cholesterol Level >130mg/dl 7.Patient having serum VLDL Cholesterol Level >40mg/dl.
• 8.Patient having Serum HDL Cholesterol Level<40mg/dl.
• 9.Patient having Serum Triglyceride Level >150mg/dl.

Exclusion Criteria

• 1.Patients having a history of untreated thyroid disorder.
• 2.Pregnant women & lactating mother.
• 3.Chronic illness and infection like TB, CA and HIV infection.
• 4.Patient is suffering with psychological disorders like anxiety, depression.
• 5.Patient with Respiratory Diseases Complications, Coronary Heart Disease, Hepatic or Renal Disease etc.
• 6.Drug induced Hyperlipidemia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Study to determine the effectiveness of Vatsakadi Vati in the dose of 500mg twice a day to maintain normal lipid profile level.	30th day,60th day

Secondary Outcome Measures

Name	Time	Method
1.To study in detail about Medovriddhi according to Ayurvedic classics.	2.To study in detail about Hyperlipidemia according to modern medicine.

Trial Locations

Locations (1)

R.A.Podar medical college, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

R.A.Podar medical college, Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr Vaishali Shamrao Meshram

Principal investigator

9403109360

vaishalimeshram30@gmail.com