CTRI

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CTRI Number

CTRI/2025/08/093901 [Registered on: 29/08/2025] Trial Registered Prospectively

Last Modified On:

27/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare the effect of Vachadi Vati with Tablet Rosuvastatin in the treatment of Hyperlipidemia.

Scientific Title of Study

A randomized controlled clinical study of Vachadi Vati in the management of Hyperlipidemia.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Snehal Chandrakant Ranzunjare
Designation	PhD scholar
Affiliation	R A Podar Ayurvedic Medical College
Address	1st Floor, department of Kayachikitsa, R A Podar Ayurvedic Medical College Dr Annie Besant Road Worli Mumbai Mumbai MAHARASHTRA 400018 India
Phone	9890022166
Fax
Email	dr.ranzunjare@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Bharat Kadlaskar
Designation	HOD and Professor
Affiliation	R A Podar Ayurvedic Medical College
Address	Kayachikitsa department R A Podar Ayurvedic Medical College Dr Annie Besant Road Worli Mumbai Mumbai MAHARASHTRA 400018 India
Phone	9422330084
Fax
Email	drkadlaskar@gmail.com

Details of Contact Person
Public Query

Name	Dr Snehal Chandrakant Ranzunjare
Designation	Phd Scholar
Affiliation	R A Podar Ayurvedic Medical College
Address	Kayachikitsa department R A Podar Medical College Dr Annie Besant Road Worli Mumbai Mumbai MAHARASHTRA 400018 India
Phone	9890022166
Fax
Email	dr.ranzunjare@gmail.com

Source of Monetary or Material Support

PDEAs College Of Ayurved and Research Centre and PDEAs Ayurved Rugnalay and Snowbell Multispeciality Hospital, Sector No. 25, Nigdi, Pune, Maharashtra, India, pin code-411044

R A Podar Ayurvedic Medical College and M A Podar Ayurvedic hospital, Worli, Mumbai, Maharashtra, India, Pin code- 400018

Primary Sponsor

Name	Dr Snehal Chandrakant Ranzunjare
Address	Kayachikitsa department R A Podar Ayurvedic Medical College Dr Annie Besant Road Worli Mumbai Maharashtra India Pin code 400018
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Snehal Chandrakant Ranzunjare	M A Podar Ayurvedic Hospital	M A Podar Ayurvedic Hospital, Dr Annie Besant Road, Worli, Mumbai, Maharashtra, India, 400018 Mumbai MAHARASHTRA	9890022166 dr.ranzunjare@gmail.com
Dr Snehal Chandrakant Ranzunjare	PDEAs Ayurved Rugnalay and Snowbell Multispeciality Hospital	PDEAs, Ayurved Rugnalay and Snowbell Multispeciality Hospital, Department of Kayachikitsa, OPD No. 117, Sec No. 27, Pradhikaran, Nigdi, Pune, Maharashtra, India 411044 Pune MAHARASHTRA	9890022166 dr.ranzunjare@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Institutional Ethical Committee PDEAs College of Ayurved and Research Centre	Approved
Institutional Ethical Committee R A Podar Ayurvedic Medical college	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E785\|\|Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	Tab Rosuvastatin	Tab Rosuvastatin 10 mg at bedtime for 60 days.
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Vachadi Vati, Reference: Ashtang Sangraha Sutrasthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: -

Inclusion Criteria

Age From	25.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Patient of Hyperlipidemia irrespective of gender 2. Patients with high blood lipid profile. 3. Lipid profile showing any one or more of the following criteria is considered for diagnosis of hyperlipidemia. According to NCEP ATP III classification following are the levels to be selected for said project Patient having Serum Total Cholesterol Level 200-239 mg/dl Patient having Serum Triglyceride Level 150-199 mg/dl Patient having Serum LDL Cholesterol Level 130-159 mg/dl Patient having Serum HDL Cholesterol Level 20-40 mg/dl Patient having serum VLDL Cholesterol Level 40-60 mg/dl Patients having one or more of above levels will be selected for said project. 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).

ExclusionCriteria

Details

1. Pregnant women & lactating mother.
2. Chronic illness and infection like TB, CA and HIV infection.
3. Patient suffering with psychological disorders like anxiety, depression.
4. Patient with Respiratory Diseases Complications, Coronary Heart Disease, Hepatic or Renal Diseases etc.
5. Drug induced Hyperlipidemia.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1. To evaluate the efficacy of Vachadi Vati in the management of Hyperlipidemia 2. To evaluate the efficacy between Vachadi Vati and Tablet Rosuvastatin in the management of Hyperlipidemia.	60 Days Follow up-Patients will be screened clinically and Lipid Profile will be repeated on 30th and 60th day.

Secondary Outcome

Outcome	TimePoints
1. To observe the effect of Vachadi Vati on Lipid levels over the period of 60 days 2. To study in detail about Rasaraktagat snehavriddhi accordingto Ayurvedi Classics.	60 Days Follow up-Patients will be screened clinically and Lipid Profile will be repeated on 30th and 60th day.

Target Sample Size

Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

09/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Hyperlipidemia is characterized by an elevated level of serum cholesterol, serum triglyceride and low-density lipoprotein and low level of high-density lipoprotein in blood. Hyperlipidemia can be very serious if not managed. The well-known leading cause of vascular diseases is hyperlipidemia. Long term exposure to sedentary lifestyle promotes atherosclerosis and subsequently develops vascular disorders like stroke, myocardial infract, peripheral artery disease, micro vascular diseases etc. Metabolic and lifestyle disorders like Diabetes, obesity, hypothyroidism; PCOS, chronic kidney disease etc. also promote to increase lipid levels in blood. The prevalence of Hyperlipidemia is increasing all over India hence there is a need to take major steps for prevention and management of Hyperlipidemia.

In Ayurveda multiple drugs have been mentioned. Their Agnivardhak, medohar, kledaghna, kaphaghna properties helps in lowering the lipid level but also useful in samprapti bhanga of Ras-raktagat snehavriddhi. Hence in current study Vachadi Vati has been chosen to treat hyperlipidemia.