| CTRI Number |
CTRI/2018/04/013239 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment for Diabetes |
|
Scientific Title of Study
|
ASSESSMENT OF HYPOGLYCEMIC ACTIVITY OF USTRI DUGDHA (SHE CAMEL MILK) & MADHUMEHARI YOGA W.S.R. DIABETES MELLITUS TYPE 2 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARISH VISHNOI |
| Designation |
PG SCHOLAR |
| Affiliation |
DR S R RAJASTHAN AYURVED UNIVERSITY |
| Address |
OPD NO.13 PG DEPARTMENT OF DRAVYAGUNA DR S R RAJASTHAN AYURVED UNIVERSITY KARWAR NAGAUR ROAD JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9468558557 |
| Fax |
|
| Email |
dr.harish.bishnoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR L N SHARMA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
Dr S R RAJASTHAN AYURVED UNIVERSITY |
| Address |
OPD NO.13 PG DEPARTMENT OF DRAVYAGUNA DR S R RAJASTHAN AYURVED UNIVERSITY KARWAR NAGAUR ROAD JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
|
| Fax |
|
| Email |
drlnsharma5178@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARISH VISHNOI |
| Designation |
PG SCHOLAR |
| Affiliation |
DR S RAJASTHAN AYURVED UNIVERSITY |
| Address |
OPD NO.13 PG DEPARTMENT OF DRAVYAGUNA DR S R RAJASTHAN AYURVED UNIVERSITY KARWAR NAGAUR ROAD JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
|
| Fax |
|
| Email |
dr.harish.vishnoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR S RAJASTHAN AYURVED UNIVERSITY JODHPUR RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
DR S RAJASTHAN AYURVED UNIVERSITY JODHPUR RAJASTHAN |
| Address |
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 |
| HARISH VISHNOI |
University Hospital of Ayurveda |
OPD NO.13 PG DEPARTMENT OF DRAVYAGUNA DR S R RAJASTHAN AYURVED UNIVERSITY KARWAR NAGAUR ROAD JODHPUR
Jodhpur
RAJASTHAN |
9468558557
harish.bishnoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehical comitee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENT WITH TYPE 2 DIABETES MELLITUS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A -UstriDugdh (She Camel Milk) |
200 ml milk per day
empty stomach for 2 month
|
| Intervention |
Group B-Madhumehari yoga |
3-5 gm churna BD and empty stomach for 2 month |
| Comparator Agent |
Group C-Madhumehari & UstriDugdh (She Camel Milk) |
200 ml per day & 3-5 gm churna twice a day empty stomach for 2 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fasting blood sugar 126to250mg/dl
2. Post prandial blood sugar 200to 300mg/dl |
|
| ExclusionCriteria |
| Details |
1. patients having type 1 Diabetes Mellitus
2. FBS >250mg/dl
3. Post prandial blood sugar >300mg/dl
4. Uncontrolled DM
5. Drug induced DM
6. patients with severe diabetic complications such as nephropathy ,retinopathy,cardiac disease ,foot ulcer
7. Age below 18 years and above 60 years
8. Pregnant woman
9. Patients who were addict drugs and drinking |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Subjective and objective parameter |
2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the comparative efficacy of the treatment
in different groups |
4 month |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/02/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Today
the Diabetes mellitus is really become the burning problem of the world. Due to
wide prevalence in the society and lack of effective medicines available
in modern medicine for this disease the subject is being chosen for the study. In rural area Ustridugdha (She Camel Milk)used
in madhumeha traditionally from many years. So the hypoglycemic activity of Ustridugdh(Camel milk) &Madhumehari yoga in the management of Madhumeha is planned to evaluate. That’s
why the camel milk has a very effective role in treatment of madhumeha. |