| CTRI Number |
CTRI/2021/03/032077 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Guduchyadi yog in high cholesterol |
|
Scientific Title of Study
|
Pharmaco-therapeutic effect of guduchyadi yog in the management of medo-roga w.s.r. to dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Singh |
| Designation |
MD Scholar PG dept. of Dravyaguna |
| Affiliation |
P.G. Department of DG, Dr. Sarvepali Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
P.G. Department of Dravyaguna Vigyan, Dr. Sarvepali Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636564642 |
| Fax |
|
| Email |
yogeshsindap4812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Prasad Purvia |
| Designation |
Assistant professor |
| Affiliation |
Dr. Sarvepali Radhakrishnan Rajasthan Ayurved University,Jodhpur |
| Address |
P.G. Department of Dravyaguna Vigyan, Dr. Sarvepali Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9782230577 |
| Fax |
|
| Email |
drrajpurvia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Singh |
| Designation |
MD Scholar PG dept. of Dravyaguna |
| Affiliation |
P.G. Department of DG, Dr. Sarvepali Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
P.G. Department of Dravyaguna Vigyan, Dr. Sarvepali Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636564642 |
| Fax |
|
| Email |
yogeshsindap4812@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD of DSRRAU Hospital, Jodhpur |
|
|
Primary Sponsor
|
| Name |
DSRRAU Jodhpur Rajasthan |
| Address |
pg dept of DG, DSRRAU karwar, nagour road, jodhpur, 342037 |
| 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 |
| Dr Rajendra Prasad Purvia |
DSRRAU, karwar, jodhpur |
OPD no. 3 PG dept of KC DSRRAU Jodhpur
Jodhpur
RAJASTHAN |
9782230577
drrajpurvia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The 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
|
| Type |
Name |
Details |
| Intervention |
GUDUCHYADI YOG |
1gm TDS (3gm/day) with luke warm water for 60 days |
| Comparator Agent |
navak guggulu |
1gm TDS (3gm/day) with luke warm water for 60 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
BMI<40
Serum cholesterol>201 mg/dl
serum triglyceride>151 mg/dl
serum low density lipoprotein>131 mg/dl |
|
| ExclusionCriteria |
| Details |
Unstable angina
myocardial infraction, cardiac failure
pregnancy/lactation
peptic ulcer, ulcerative collitis
impaired renal function |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| management of medoroga w.s.r. dyslipidemia |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find the efficacy of guduchyadi yog |
60 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
22/03/2021 |
| 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="5"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To review, compile and evaluate the availahle literature related with Guduchyadi yog explained in Ayurveda and modern text. To review, compile and evaluate the available literature related with medoroga and Dyslipidemia as explained in Ayurveda and modern text. Pharmacognostical study of Guduchi, Kantkari & Pippali. To evaluste the therapeutic efficacy of "Guduchyndi yog" in the management of Dyslipidemia (medoroga). |