| CTRI Number |
CTRI/2021/01/030176 [Registered on: 01/01/2021] Trial Registered Prospectively |
| Last Modified On: |
26/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Diagnostic
Preventive
Screening
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Diabetes Management Through Ayurveda |
|
Scientific Title of Study
|
A Clinical Study Of Takradhara And Trivrutadi Choorna Virechana In 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 |
Dr Sunita |
| Designation |
MD Scholar |
| Affiliation |
University College of Ayurveda Dr. Sarvepalli Radhakrishnan Ayurved University |
| Address |
P.G. Department of Panchkarma , University College of Ayurveda Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University,Karwar, Nagaur Road, Jodhpur
department of panchkarma jodhpur
india
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460120741 |
| Fax |
|
| Email |
sunitaprajapat721@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh sharma |
| Designation |
associate professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
P.G. Department of Panchkarma , University College of Ayurveda Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University,Karwar, Nagaur Road, Jodhpur
department of panchkarma jodhpur
india
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829695452 |
| Fax |
|
| Email |
drmksharma2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita |
| Designation |
MD Scholar |
| Affiliation |
University College of Ayurveda Dr. Sarvepalli Radhakrishnan Ayurved University |
| Address |
P.G. Department of Panchkarma , University College of Ayurveda Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University,Karwar, Nagaur Road, Jodhpur
department of panchkarma jodhpur
india
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460120741 |
| Fax |
|
| Email |
sunitaprajapat721@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S. R. Rajasthan ayurveda University, Karwar Jodhpur
P.g. department of panchkarma
University hospital of ayurveda
|
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan ayurveda University KARWAR Nagaur Road Jodhpur PIN 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 Mahesh Kumar Sharma |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, University Hospital Of Ayurveda |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda OPD No.7, P.G. Department Of Panchkarma,
University, Karwar, Nagaur Road, Jodhpur Pin 342037
Jodhpur
RAJASTHAN |
919829695452
drmksharma2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| the institutional ethics committee"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. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Takradhara, Virechana |
Group A – 15 Patients Of Diabetes Mellitus Will Be Give Virechana By Trivrutadi Choorna For 2 Times In 45 Days .
Dose – Depand On Patient Kosth
Group B - 15 Patients Of Diabetes Will Be Given
Takradhara For 21 Days In 2 Step. Each Step Having 10 Days And These 2 Steps Having Gap Of 10 Days. In This Gap There Is No Procedure .
Time Duration Of Takradhara -30 Min
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
confirmed case of diabetes mellitus type 2 on the basis of laboratory investigation and observed sign and symptoms
patients having FBS level range between 110-200 mg/dl and PPBS between 140 -250 mg/dl will be selected for the study
glycosylated hemoglobin range < 7% |
|
| ExclusionCriteria |
| Details |
1. type 1 diabetes mellitus,
2. insulin dependent
3. gestational diabetes
4. having any other systemic disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Improvement In Subjective And Objective Parameters.Find Out The Comparative Efficacy Of The Treatment In Both The Group |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Find Out The Comparative Efficacy Of The Treatment In Both The Group |
45 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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2021 |
| 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="7"
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
|
Madhumeha is vatic disease caused by excess intake of guru - snigdh food , aml - lavan ras ,too much sleeping ,too much rest , lack of exercise ,lack of vaman - virechana by the patients of madhumeha rog as acharya charak has mentioned in its pathogenesis. Type -2 Diabetes Mellitus is due to insulin [hormone ] resistance . So the body is unable to use insulin .about 90% of diabetic patients have Type -2 Diabetes Mellitus. It usually occurs after 40 years . This study is open labelled parallel group trial of 30 patients to prove the efficacy of takradhara and trivrutadi choorna virechana in the management of madhumeh rog . in which 15 patients of diabetes will be given trivrutadi choorna virechana for 2 times within 45 days.other 15 patients of diabetes will be given takradhara for 21 days in 2 step. each step having 10 days and these 2 steps having gap of 10 days. In this gap there is no procedure . |