| CTRI Number |
CTRI/2024/03/063977 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the comparative effect of vachadi yoga and haridradi yoga in the management of dyslipidemia(medodusthi). |
|
Scientific Title of Study
|
A randomized parallel arm comparative clinical study to determine the efficacy of vachadi yoga and haridradi yoga in the management of dyslipidemia (medodushti). |
| 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 Sonam Tyaral |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD No 2,3,10,Kayachikitsa department,Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur.
Solapur
MAHARASHTRA
413002
India |
| Phone |
9850042728 |
| Fax |
|
| Email |
sonam.tyaral@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Swami |
| Designation |
Associate Professor, Kaychikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur.
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422957234 |
| Fax |
|
| Email |
santosh.swami@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonam Tyaral |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD No 2,3,10,Kayachikitsa department, Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur.
Solapur
MAHARASHTRA
413002
India |
| Phone |
9850042728 |
| Fax |
|
| Email |
sonam.tyaral@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur. |
|
|
Primary Sponsor
|
| Name |
Dr Sonam Tyaral |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur. |
| 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 Sonam Tyaral |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
OPD no 2,3 Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur.
Solapur
MAHARASHTRA |
9850042728
sonam.tyaral@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth govindji raoji ayurved mahavidyalaya ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: Dyslipidemia , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridradi yoga, Reference: Ashtanga sangraha sutrasthan 16/28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachadi yoga, Reference: Ashtanga sangraha sutrasthana 16/28-29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Newly diagnosed cases of Dyslipidemia will be selected.
2) Known cases of Dyslipidemia will be included which are not taking
any medication from last 3 months(abstinence period for 3 months)
3) Participants of one OR all of the following altered lipid levels will
be selected.
4) Age group - 20 – 60 years
5) Participants irrespective gender and religion will be selected. |
|
| ExclusionCriteria |
| Details |
1) Uncontrolled Diabetes mellitus.
2) Uncontrolled Hypertension.
3) Participant with known case of Hypothyroidism will be excluded.
4) Participant having serious Cardiac disorders like MI, Cardiac
failure etc.
5) Participant with Severe Hepatic disorders like Liver cirrhosis,
alcoholic liver disease.
6) Drug induced Dyslipidemia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine effect of Vachadi Yoga in the management of Dyslipidemia (Medodushti). |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study safety of Vachadi Yoga & Haridradi Yoga in the
management of Medodushti (Dyslipidemia).
|
30 Days |
| To study the pathophysiology & details about dyslipidemia |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
01/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dyslipidemia is abnormally elevated cholesterol or fats (lipids e.g. fats, triglycerides, cholesterol, phospholipids) or lipoproteins) in the blood. Dyslipidemia is a single contributory factor for many life style diseases. Keeping in view prevalence and complications of Dyslipidemia, limitations in treatment the present study has been designed to compare the efficacy of Vachadi Yoga and Haridradi Yoga in the management of The study will be conducted for 30 days. There will be follow up on 10th, 20th and 30th day, Vachadi Yoga or Haridradi Yoga given before food for 30 days. Before and after treatment assessment will be done with the help of lipid Profile. |