| CTRI Number |
CTRI/2025/06/089422 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the role of snehapana and virechana in dyslipidemia |
|
Scientific Title of Study
|
Comparative clinical study to evaluate two different modalities of Shodhananga
snehapana with Murchita tila taila and Varunadi ghrita followed by Virechana in
dyslipidaemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSuma S Sadar Joshi |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda and Hospital, Hassan |
| Address |
h.No.2, 2nd floor, Hilltop residency, B wing, Opposite to Shri Gomatesh Polytechnic College, Bhagyanagar 10th Cross, Belagavi
Belgaum
KARNATAKA
590011
India |
| Phone |
9449515046 |
| Fax |
|
| Email |
sumamaski@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuma S Sadar Joshi |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda and Hospital, Hassan |
| Address |
h.No.2, 2nd floor, Hilltop residency, B wing, Opposite to Shri Gomatesh Polytechnic College, Bhagyanagar 10th Cross, Belagavi
Belgaum
KARNATAKA
590011
India |
| Phone |
9449515046 |
| Fax |
|
| Email |
sumamaski@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSuma S Sadar Joshi |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda and Hospital, Hassan |
| Address |
h.No.2, 2nd floor, Hilltop residency, B wing, Opposite to Shri Gomatesh Polytechnic College, Bhagyanagar 10th Cross, Belagavi
Belgaum
KARNATAKA
590011
India |
| Phone |
9449515046 |
| Fax |
|
| Email |
sumamaski@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, B M Road, Hassan - 573201
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
DrSuma S Sadar Joshi |
| Address |
H.no.1, 2nd floor, Hilltop residency B wing, Opposite to Shri Gomatesh Polytechnic College, 10th cross Bhagyanagar, Belagavi-590011 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSuma S Sadar Joshi |
SDM College of Ayurveda and Hospital Hassan |
Panchakarma OPD
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
B.M Road, Thanniruhalla, Hassan
Hassan
KARNATAKA |
9449515046
sumamaski@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B.M Road, Thanniruhalla, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | snehanasekaH, सà¥à¤¨à¥‡à¤¹à¤¨à¤¸à¥‡à¤•à¤ƒ | (Procedure Reference: Charaka and Vangasena Samhita, Procedure details: Total 4-groups
Group A1: Murchita tila taila, Arohana krama snehapana
Group A2: Murchita tila taila, fixed Arohana krama snehapana of 30ml/day
)
| | 2 | Intervention Arm | Procedure | - | snehapAna-karma, सà¥à¤¨à¥‡à¤¹à¤ªà¤¾à¤¨-करà¥à¤® | (Procedure Reference: Vangasena Samhita, Procedure details: Group B1 : Varunadi ghrita, Arohana krama snehapana
Group B2 : Varunadi ghrita, fixed Arohana krama snehapana 30ml/day)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI Range from 18.5 to 34.9 will be taken for the study
•
Subjects with borderline high and high as per the NCEP ATP III criteria
•
Subjects fit for Virechana
•
Subjects between 30 to 60yrs of age |
|
| ExclusionCriteria |
| Details |
Having associated disorders like
Diabetes
Hypothyroidism
Nephrotic syndrome
Obstructive liver disease
Chronic renal failure
Drugs, that may raise LDL cholesterol or cause another dyslipidaemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Studies have shown normalcy of the lipid profile |
Baseline, Day 11, Day 16 and Day24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lipid profile may come normal |
Before and after the study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/01/2026 |
| 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="2"
Months="2"
Days="2" |
|
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
|
Studies have been conducted to manage dyslipidaemia through Panchakarma procedures involving Snehapana and Virechanakarma. Lipid profile regulation noted in the studies. The studies involved gradual increase of snehapana dose as per the agni. In Vangasena Samhita we get reference of fixed increase of snehapana dose not involving agni assessment. The present study is planned to compare these two modes of snehapana with Murchita tila taila and Varunadi ghrita followed by Virechana in dyslipidaemiaOBJECTIVES OF THE STUDY 1.Primary objective a.To assess the effect of Arohana krama of Snehapana with Murchita tila taila followed by Virechana in dyslipidaemia b.To assess the effect of fixed dose of Arohana krama Snehapana with Murchita tila taila followed by Virechana in dyslipidaemia c.To assess the effect of Arohana krama of Snehapana with Varunadi ghrita followed by Virechana in dyslipidaemia d.To assess the effect of fixed dose of Arohana krama Snehapana with Varunadi ghrita followed by Virechana in dyslipidaemia 2.Secondary objective a.To assess the Samyak snigdha lakshanas b.To assess the Samyak Virikta Lakshanas c.To study the changes in biochemical parameters d.To compare between the groups
Study design CONTROLLED COMPARATIVE CLINICAL TRIAL Study type : Interventional Estimated enrolment : Minimum of 100 participants Allocation : Randomized Interventional Model : Two Arm Parallel Assignment Masking : Open Label Study Primary purpose : Treatment
Drugs *For Deepana Pachana with Ajamodadi churna *For Udwartna with Kolakulatthadi churna *Snehana with Murchita tila taila and Varunadi ghrita *Virechana with Vidanga Tanduladi yoga *Samsarjana krama
Subjective parameters Before and after Deepana pachana Agni Ama Kostha
For Samyak snigdha lakshanas Vatanulomana Agnidipti Snehodvega Klama/Glani Angalaghavata Purisha- Twak- Gatra snigdhata Sneha -jeerya maana lakshanas
For Virechana Laingiki Shuddhi Antiki Shuddhi
Objective parameters Weight BMI Chest circumference Mid-arm circumference Waist circumference Mid-thigh circumference Resting metabolism Body fat percentage Visceral fat level
For Dyslipidaemia Total Cholesterol Triglycerides LDL HDL
For Virechana Vegiki Shuddhi
Investigation: Lipid profile & CRP |