| CTRI Number |
CTRI/2024/08/072787 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to the effect of Phaltrikadi yoga in Medoroga (Dyslipidemia). |
|
Scientific Title of Study
|
A clinical study to determine the efficacy of Phaltrikadi yoga in the management of Medoroga with special reference 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 |
Prof Vijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Ayurvedic College And Hospital |
| Address |
Room number 317 department of kayachikitsa Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Soni |
| Designation |
Lecturer |
| Affiliation |
Rajiv Gandhi Ayurvedic College and Hospital |
| Address |
Room number 317 hospital building Rajiv Gandhi Ayurvedic College and Hospital Paprola District Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219121014 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh Acharya |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Ayurvedic College and Hospital |
| Address |
Room number 317 hospital building Rajiv Gandhi Ayurvedic College and Hospital Paprola District Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7060155594 |
| Fax |
|
| Email |
rameshacharya314@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Ayurvedic College And Hospital Paprola district Kangra Himachal Pradesh 176115 |
|
|
Primary Sponsor
|
| Name |
Principal Rajiv Gandhi Ayurvedic College and Hospital |
| Address |
Paprola District Kangra Himachal pradesh 176115 |
| 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 |
| Prof Vijay Chaudhary |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital |
Department of kayachikitsa Room number 317 Paprola District Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
9418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human |
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: MEDOROGAH, (2) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Rosuvastatin | 10 mg once daily at bed time | | 2 | Intervention Arm | Drug | Classical | | |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with serum lipid level
.serum cholesterol -200-350 mg/dl
.serum triglycerides -150-350 mg/dl
.serum LDL -100-200 mg/dl
.serum VLDL -30-100 mg/dl
.serum HDL -20-40 mg/dl
Patient willing to participate in the trial
patient between the age group of 30-70 years of eiter gender will be selected for the study. |
|
| ExclusionCriteria |
| Details |
Patient having illness like carcinoma, renal and liver disorders.
Patient having past history of myocardial infraction, unstable angina and congestive cardiac failure and cerebrovascular accident.
Pregnant females and lactating mother. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Phaltrikadi Yoga in the management of Medoroga with special reference to Dyslipidemia. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety of Phaltrikadi Yoga in patient of Medoroga with special reference to Dyslipedemia. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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="3"
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
|
I would like to publish my trial after its completion as soon as possible. This study is a randomized open clinical trial comparing the safety and efficacy of Phaltrikadi Yoga and Rosuvastatin for 12 weeks in 30 patients with Medo Roga w.s.r. to Dyslipidaemia. 30 patients will be randomly divided into 2 groups of 15 patients in each group. The patients will be selected from OPD/IPD of Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Distt. kangra, H.P. |