| CTRI Number |
CTRI/2025/03/082027 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study on the Efficacy of Virechana followed by Bruhat Panchamoola Kashaya in the Management of impaired cholesterol levels |
|
Scientific Title of Study
|
An Open Label Randomised Controlled Clinical Study to Evaluate the Efficacy of Virechana followed by Bruhat Panchamoola Kashaya in the Management of 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 Sai Sudha C S |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
#82, Sri Sai Annapoorna, 2nd main, 2nd cross, Kandaayanagar, Srirampura, 2nd stage, Mysuru
41/E, Lalithadripura Road, Alanahalli, Mysuru, 1st floor, Department of PG Studies in Kayachikitsa
Mysore
KARNATAKA
570023
India |
| Phone |
9945416262 |
| Fax |
|
| Email |
saisudha1300@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh A Udapudi |
| Designation |
Professor and HoD |
| Affiliation |
JSS Ayurveda Medical College and Hospital, Mysuru |
| Address |
JSS Ayurveda Medical College and Hospital, 1st floor, Department of PG Studies in Kayachikitsa, 41/E, Lalithadripura Road, Alanahalli, Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9844136277 |
| Fax |
|
| Email |
drrajeshudapudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh A Udapudi |
| Designation |
Professor and HoD |
| Affiliation |
JSS Ayurveda Medical College and Hospital, Mysuru |
| Address |
JSS Ayurveda Medical College and Hospital, 1st floor, Department of PG Studies in Kayachikitsa, 41/E, Lalithadripura Road, Alanahalli, Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9844136277 |
| Fax |
|
| Email |
drrajeshudapudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sai Sudha C S
82, Sri Sai Annapoorna, 2nd main, 2nd cross, Kandaayanagar, Srirampura, 2nd stage, Mysuru-570023, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Sai Sudha C S |
| Address |
82, Sri Sai Annapoorna, 2nd main, 2nd cross, Kandaayanagar, Srirampura, 2nd stage, Mysuru-570023 |
| 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 |
| Dr Sai Sudha C S |
JSS Ayurveda Medical College and Hospital |
41/E, Ground floor, OPD 1, Lalithadripura Road, Alanahalli, Mysuru-570028, Karnataka, India
Mysore
KARNATAKA |
9945416262
saisudha1300@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charaka Samhita, Procedure details: Deepana Pachana with Hingwashtaka Churna for 3-7 days
Snehapana with Varunadi Ghrita for 3-7 days
Sarvanga Abhyanga with Murchita Tila Laila followed by Bhashpa Sweda for 3 days
Virechana with Trivrut Lehya for 1 day)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bruhat Panchamoola Kasha, Reference: Sarngadhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -1 tablespoon Made), Additional Information: - | | 3 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charaka Samhita, Procedure details: Deepana Pachana with Hingwashtaka Churna for 3-7 days
Snehapana with Varunadi Ghrita for 3-7 days
Sarvanga Abhyanga with Murchita Tila Laila followed by Bhashpa Sweda for 3 days
Virechana with Trivrut Lehya for 1 day)
| | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Kashaya , Reference: Sarngadhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -1 tablespoon Madhu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Serum CHOLESTEROL (201-400mg/dL)
Serum TRIGLYCERIDES (150-400mg/dL)
Serum LDL (130-189mg/dL)
Serum HDL (1-40mg/dL)
Serum VLDL (31-100mg/dL) |
|
| ExclusionCriteria |
| Details |
Subjects with uncontrolled Diabetes Mellitus with HbA1c more than 10 per cent, IDDM or Hypertension with SBP/DBP more than or equal to 160/110mmHg
Subjects with any other known systemic disorder which may interfere with the study
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Virechana followed by Bruhat Panchamoola Kashaya in the management of Dyslipidemia |
0th day
71st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lipid profile test |
Before treatment - 0th day
After Virechana - 14th to 16th day
After treatment - 59th to 71st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/03/2025 |
| 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="1"
Months="6"
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
|
Dyslipidemia is a disorder of lipoprotein metabolism, which can include overproduction or deficiency of lipoproteins or both. The disorder can manifest as an elevation of plasma cholesterol, triglycerides, or both, or a low HDL level or all three together that contributes to the development of atherosclerosis. The prevalence of Dyslipidemia across the nation has been reported as; 24.0% of hypercholesterolemia, 20.9% of high LDL-cholesterol, 66.9% low HDL-cholesterol and 32.1% of hypertriglyceridemia. Cardiovascular disease is the most significant complication of Dyslipidemia owing to more than 4 million deaths each year, worldwide. The management protocol for Dyslipidemia includes lifestyle modifications, diet, exercise and administration of statins in various intensities. Statin therapy is also used in primary and secondary prevention of the disease. It is added with two other classes of medications aimed at inhibiting the absorption of cholesterol and decreasing LDL-C levels which has in turn shown to decrease cardiovascular outcomes. Many Ayurvedic formulations have been proven to have anti-dyslipidemic activity. There remains a scope for research in this field owing to the prevalence of the disease. Therefore, Bruhat Panchamoola Kasha has been chosen as the trial drug for the present study. Triphala Kasha, a proven drug for Dyslipidemia, is taken as the control drug. |