| CTRI Number |
CTRI/2019/01/017241 [Registered on: 24/01/2019] Trial Registered Prospectively |
| Last Modified On: |
23/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Diabetes(suger) |
|
Scientific Title of Study
|
“PHARMACO-THERAPEUTIC ROLE OF BIJKADI YOG (KALPIT YOG) IN MANAGEMENT OF MADHUMEHA W.S.R. TO DIABETES MELLITUS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
balraj singh rathore |
| Designation |
MD SCHOLAR |
| Affiliation |
DrSarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
143 rail nager nirman nager jaipur rajasthan
PG Department of DravyaGuna University College of Ayurveda
Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
302019
India |
| Phone |
08949922852 |
| Fax |
|
| Email |
dr.balrajsingh6271@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Laxmi narayan sharma |
| Designation |
Associate professor |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department of DravyaGuna University College of Ayurveda
Rajasthan Ayurved University Karwar Nagaur road Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9413095390 |
| Fax |
|
| Email |
drlnsharma5178@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
balraj singh rathore |
| Designation |
md scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
143 rail nager nirman nager jaipur rajasthan
Jodhpur
RAJASTHAN
302019
India |
| Phone |
08949922852 |
| Fax |
|
| Email |
dr.balrajsingh6271@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department of DravyaGuna University college of Ayurveda
Rajasthan Ayurved University Karwar Nagaur Road Jodhpur |
| 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 |
| balraj singh rathore |
University Hospital of Ayurveda,Dr.sarvepalli Radhakrishnan Rajasthan Ayurved University |
PG Department of
DravyaGuna University
college of Ayurveda
Rajasthan Ayurved
University Karwar
Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
8949922852
dr.balrajsingh6271@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| dsrrau jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A bijakadi yog |
500mg bd tab with palash puspahim for one month |
| Comparator Agent |
group B - madhumehari churna |
madhumehri churna 3gm bd with water for one month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(a) Diagnosed and confirmed cases of Diabetes Mellitus type II, on the basis of the laboratory investigations.
(b) Patients between the age group of 18-60 years of either sex.
|
|
| ExclusionCriteria |
| Details |
1. Patients having Type - DM I [IDDM]
2. Age below 18 and above 60 years.
3. Patient of type II DM who are on Insulin therapy.
4. DM with complications.
5. Uncontrolled DM
8. Drug induced DM.
9. FBS [>250mg/dl]
10. PPBS [>300mg/dl]
11. DM with coronary artery disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate pharmacological and therapeutic
efficacy of drug bijkadi yog |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of bijkadi yog on control sugar level in diabetes mellites |
one month |
|
|
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 1 |
|
Date of First Enrollment (India)
|
02/02/2019 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The drugs of bijakadi yog taken for present study,which is describe as a medicine of premeha in nighantus of dravyaguna in ayurveda .The scientific evaluation of such drugs along with their fundamental principles is essential for their universal acceptance.Hence in this study an attempt is made to prepare a drug regarding type 2 diabetes. Through pharmacological and clinical trial in the present study it will be tried to prove the efficacy of the bijakadi yog for in the management of type 2 diabetes
|