CTRI

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CTRI Number

CTRI/2026/03/106179 [Registered on: 13/03/2026] Trial Registered Prospectively

Last Modified On:

12/03/2026

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 Effect of Haridradi Churna and Tryushnadya Churna in the Dyslipidemia (Medodushti)

Scientific Title of Study

RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF HARIDRADI CHURNA AND TRYUSHNADYA CHURNA IN THE MANAGEMENT OF MEDODUSHTI W.S.R. TO DYSLIPIDEMIA.

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 Shraddha Savaj
Designation	pg Scholar
Affiliation	Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Address	pg Department of Kaya Chikitsa Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 Udaipur RAJASTHAN 313001 India
Phone	9664976185
Fax
Email	shraddhasavaj61@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Indumati sharma
Designation	Associate Professor
Affiliation	Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Address	pg Department of Kaya Chikitsa Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 Udaipur RAJASTHAN 313001 India
Phone	797672310
Fax
Email	drindusharma4@gmail.com

Details of Contact Person
Public Query

Name	Dr Shraddha Savaj
Designation	pg scholar
Affiliation	Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Address	pg Department of Kaya Chikitsa Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 Udaipur RAJASTHAN 313001 India
Phone	09664976185
Fax
Email	shraddhasavaj61@gmail.com

Source of Monetary or Material Support

Madan Mohan Malviya Government Ayurved College Udaipur rajasthan 313001

Primary Sponsor

Name	Madan Mohan Malviya Government Ayurved College Udaipur
Address	pg Department of kaya chikitsa Madan Mohan Malviya Government Ayurved College Udaipur rajasthan 313001
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
nil	nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shraddha Savaj	Madan Mohan Malviya government ayurved college udaipur	OPD No. 3 Kaya chikitsa department Madan Mohan Malviya government ayurved college udaipur rajasthan pincode 313001 Udaipur RAJASTHAN	09664976185 shraddhasavaj61@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
institutinal ethics committee mmm govt ayurved college udaipur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E782\|\|Mixed hyperlipidemia. Ayurveda Condition: MEDAHSTHITAKAPAKOPAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Tryushnadya Churna, Reference: brihat yog tarangini 104/36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: madhu-ghrita), Additional Information: nil
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Haridradi Churna, Reference: A.H.SU.15/35-36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: nil

Inclusion Criteria

Age From	20.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1.Patients aged 20 to 70 years, both male and female. 2.Diagnosed cases of Dyslipidemia and Medodushti based on the criteria given by NCEP ATPIII. Any one of the following values: Serum cholesterol 200 mg per dl or more, Serum triglycerides 150 mg per dl or more, LDL cholesterol 130 mg per dl or more, HDL cholesterol less than 40 mg per dl. 3.Patients having clinical signs and symptoms of Dyslipidemia.

ExclusionCriteria

Details

1. Age below 20 years and above 60 years.

2. Patients with serious cardiovascular diseases such as unstable angina, recent myocardial infarction, uncontrolled hypertension with diastolic BP more than 100 mmHg, or poorly controlled diabetes mellitus.

3. Patients with LDL 190 mg per dl or more and triglycerides 500 mg per dl or more.

4. Individuals with poor kidney function with serum creatinine 2 mg per dl or more.

5. Patients diagnosed with or suspected to have any type of malignancy or other life threatening condition.

6. Pregnant or breastfeeding women and patients whose dyslipidemia is caused by medicines such as glucocorticoids or diuretics.

7. Heavy alcohol drinkers and drug abusers.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1)Reduction in the level of Serum Triglycerides and Serum LDL. 2)Increase in Serum HDL level	Baseline (Day 0), Mid-treatment (Day 15), Post-treatment (Day 30), and Follow-up (Day 45 & 60).

Secondary Outcome

Outcome	TimePoints
1)Reduction in weight 2)Reduction in Apolipoprotein B. 3)Qualitative improvement in lifestyle changes	Baseline(day0),Mid treatment (day15),Post treatment(day30),follow up (day45 & day60).

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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 3

Date of First Enrollment (India)

05/07/2026

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="0"
Months="10"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE HARIDRADI CHURNA AND TRYUSHNADYA CHURNA IN THE MANAGEMENT OF MEDODUSHTI WITH SPECIAL REFERENCE TO DYSLIPIDEMIA

Summary

There will be two group in the study, in Group A randamly selected and clinically diagnosed 30 patient of Medodushti will be given Haridradi Churna twice a day before meal, Group B 30

patient of Medodushti will be given Tryushnadya Churna twice a day before meal,both trial will be conducted for a period of 2 months. Follow up of the case will be after 15 days that is four time during treatment. Final assesment will be done after completion of Two month course on the basis of subjective, objective and laborateral assesment.