| CTRI Number |
CTRI/2021/07/035303 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL STUDY OF GUDUCHYADI CHURNA AND DIET CHART ON DISLIPIDAEMIA |
|
Scientific Title of Study
|
AETIOPATHOLOGICAL STUDY OF MEDOROG W.S.R.TO DISLIPIDAEMIA AND THERAPEUTICAL TRIAL OF GUDUCHYADI CHURNA |
| Trial Acronym |
GADC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shila Chhipa |
| Designation |
Md Scholar Of Rog Nidan |
| Affiliation |
Madan Mohan Malviya Govt Ayurvedic Medical College Udaipur |
| Address |
Madan Mohan Malviya Govt Ayurvedic College Udaipur Ambamata 313004 Udaipur
Rajasthan
Udaipur
RAJASTHAN
313004
India |
| Phone |
9413053305 |
| Fax |
|
| Email |
sheila.chhipa08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pankaj Marolia |
| Designation |
Professor And Head Of Department |
| Affiliation |
Madan Mohan Malviya Ayurvedic Medical College Udaipur |
| Address |
Pg Department Of Rog Nidan Madan Mohan Malviya Govt Ayurvedic College Udaipur Ambamata 313004
Rajasthan
Udaipur
RAJASTHAN
313004
India |
| Phone |
9413193101 |
| Fax |
|
| Email |
pankajmarolia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shila Chhipa |
| Designation |
MD scholar of Rog nidan |
| Affiliation |
Madan Mohan Malviya Govt Ayurvedic Medical College Udaipur |
| Address |
ADAN MOHAN MALVIYA GOVT AYURVEDIC COLLLEGE UDAIPUR AMBAMATA 313004 UDAIPUR
RAJASTHAN
Udaipur
RAJASTHAN
313004
India |
| Phone |
9413053305 |
| Fax |
|
| Email |
sheila.chhipa08@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOADAN MOHAN MALVIYA GOVT AYURVEDIC COLLEGE UDAIPUR |
|
|
Primary Sponsor
|
| Name |
MOADAN MOHAN MALVIYA GOVT AYURVEDIC COLLEGE UDAIPUR |
| Address |
Madan Mohan Malviya Govt Ayurvedic College Udaipur Ambamata 313004 |
| 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 Shila Chhipa |
MADAN MOHAN MALVIYA AYURVEDIC COLLEGE UDAIPUR |
PG DEPT OF ROG NIDAN MADAN MOHAN MALVIYA AYURVEDIC COLLEGE UDAIPUR AMBAMATA 313004
Udaipur
RAJASTHAN |
9413053305
sheila.chhipa08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM govt ayurvedic college Udaipur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchyadi churna |
5 gm twice in a day orally before meal for 30 days |
| Comparator Agent |
Guduchyadi Churna and Diet chart |
5 gms twice daily for 30 days and Diet follow for 30 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 patientse willing to give consent for clinical trial.
2 patients having clinical sign and symptoms of dislipidaemia |
|
| ExclusionCriteria |
| Details |
1 BMI>40
2 hormonal imbalance
3 any serious ailment as CVD,Malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in signs and symptoms of dislipidaemia |
Changes in signs and symptoms of dislipidaemia After 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in grading score of dislipidaemia |
30 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
05/08/2021 |
| 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="1"
Months="0"
Days="0" |
|
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
|
INTRODUCTION: The worldwide percentage of noncommunicable diseases are increasing and becoming hazardious for life ,and MedoRog/Dislipidaemia is one of them.Medorog is defined as abnormal / or excessive fat accumulation in the body.
AIMS AND OBJECT: To conduct Prakriti Parikshan ,Nidanatmak study of MedoRog& correlative study with Dislipidaemia. Therapeutic study to evaluate the efficacy of Guduchyadi churna To evaluate the results after laboratory investigation.
NEED OF STUDY: In modern era sedentary life style generally leads to Santarpanotth Vikarlike Medorog/Dislipidaemia. And Medorog/Dislipidaemia increases the risk of CVD ,Diabeties,Hypertension and many other ailments. Medorog can be manged by diet chart and Ayurvedic intervention.
Study Drug ; Guduchyadi Churna (Yogratnakar) |