| CTRI Number |
CTRI/2025/03/082498 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF GUDUCHYADI YOGA AND PHALATRIKADI YOGA IN high blood cholesterol MANAGEMENT |
|
Scientific Title of Study
|
A CLINICAL STUDY OF GUDUCHYADI YOGA AND PHALATRIKADI YOGA IN THE MANAGEMENT OF RASA DHATU GATA SNEHA VRIDDHI W.S.R. TO 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 |
Ashwini chouhan |
| Designation |
post graduation scholar |
| Affiliation |
Govt Dhanwantari Ayurvedic medical college and hospital ujjain M.P, |
| Address |
OPD no 27 department of kayachikitsa GOVT Dhanwantari Ayurveda hospital and college near chimanganj police station ujjain Madhya pradesh
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
7974698862 |
| Fax |
|
| Email |
ashwini787chauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh jain |
| Designation |
Associate Professor |
| Affiliation |
Govt Dhanwantari Ayurvedic medical college and hospital ujjain M.P |
| Address |
OPD no 27 department of kayachikitsa GOVT Dhanwantari Ayurveda hospital and college near chimanganj police station ujjain Madhya pradesh
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9826064756 |
| Fax |
|
| Email |
nareshjainujn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh jain |
| Designation |
Associate Professor |
| Affiliation |
Govt Dhanwantari Ayurvedic medical college and hospital ujjain M.P |
| Address |
OPD no 27 department of kayachikitsa GOVT Dhanwantari Ayurveda hospital and college near chimanganj police station ujjain Madhya pradesh
MADHYA PRADESH
456001
India |
| Phone |
9826064756 |
| Fax |
|
| Email |
nareshjainujn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Dhanwantari Ayurvedic Medical college and hospital ujjain mp |
|
|
Primary Sponsor
|
| Name |
Govt Dhanwantari Ayurvedic Medical college and hospital ujjain mp |
| Address |
OPD no 27 department of kayachikitsa GOVT Dhanwantari Ayurveda hospital and college near chimanganj police station ujjain Madhya pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ashwini Chouhan |
Govt Danwantari Ayurvedic Medical college and hospital ujjain mp |
OPD no 27 department of kayachikitsa GOVT Dhanwantari Ayurveda hospital and college near chimanganj police station ujjain Madhya pradesh
Ujjain
MADHYA PRADESH |
7974698862
ashwini787chauhan@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:I709||Other and unspecified atherosclerosis. Ayurveda Condition: RASAVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GUDUCHYADI YOGA , Reference: YOGARATNAKAR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: -no | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PHALATRIKADI YOGA, Reference: YOGARATNAKAR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed and confirmed cases of hyperlipidemia on the basis of investigation
patient aged more than 20 yrs and less than 60 years
patient with clinical signs and symptoms of medoroga as mention in ayurveda and modern |
|
| ExclusionCriteria |
| Details |
pt aged less than 20 yrs and more than 60 yrs
pt suffering from type 1 DM and uncontrolled DM OR uncontrolled hyperlipidemia
drug induced or uncontrolled hyperlipidemia
pt having illness like tuberculosis carcinoma endocrine disorder or major illness like renal or liver disorder
pt having the past history of myocardial infraction and unstable angina
pt having clinical features of CCP |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce the classical signs and symptoms of hyperlipidemia like anxiety sweating, obesity etc |
to reduce the classical signs and symptoms of hyperlipidemia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effective management of rasa dhatu gata sneha vriddhi (hyperlipidemia) by relieving the symptoms |
2 months |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2025 |
| 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="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
|
This is a randomized interventional study of GUDUCHYADI YOGA and PHALATRIKADI YOGA in the management of rasa dhatu gata sneha vriddhi .Total 60 patients will be enrolled in the present study .Selected patients will be divided into three group on the basis of computer generated randomisation.Group A containing 20 patients will be given GUDUCHYADI YOGA .Group B containing 20 patients will be given PHALATRIKADI YOGA and in the third group containing 20 patients will be given both GUDUCHYADI YOGA and PHALATRIKADI YOGA ........follow up will be on 15 days. |