| CTRI Number |
CTRI/2015/10/006281 [Registered on: 19/10/2015] Trial Registered Prospectively |
| Last Modified On: |
04/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of puta in Abharaka marana w.s.r. to Madhumeha ( Type 2 DM) |
|
Scientific Title of Study
|
EFFECT OF PUTA IN ABHRAKA MARANA W.S.R. TO MADHUMEHA ( TYPE-2 DM ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Baban Bhurkunde |
| Designation |
MD 2nd Year Scholar |
| Affiliation |
Institute for Pst Graduate Teaching and Research in Ayurveda Jamnagar |
| Address |
Dept of RS BK IPGT RA Jamnagar Dept of RS BK IPGT RA
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
08484013788 |
| Fax |
|
| Email |
sunilmdjamnagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Bedarkar |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Pst Graduate Teaching and Research in Ayurveda Jamnagar |
| Address |
Dept of RS BK IPGT RA Jamnagar Dept of RS BK IPGT RA
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
08128217370 |
| Fax |
|
| Email |
drprashantbedarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Bedarkar |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Pst Graduate Teaching and Research in Ayurveda Jamnagar |
| Address |
Dept of RS BK IPGT RA Jamnagar Dept of RS BK IPGT RA
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
08128217370 |
| Fax |
|
| Email |
drprashantbedarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT AND RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Jamnagar 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SUNIL BHURKUNDE |
IPGT and RA |
JAMNAGAR
Jamnagar
GUJARAT |
8484013788
sunilmdjamnagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGT/7/-A/Ethics/2014-15/1538 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
MADHUMEHA (TYPE-2 DM) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Less number of Puta ie 3 Puti Abhraka Bhasma |
187.5 mg with Triphala Ghana 250 mg twice a day
for 4 weeks with 2 weeks follow up |
| Intervention |
More number of Puta ie 10 Puti Abhraka Bhasma |
187.5 mg with Triphala Ghana 250 mg twice a day for 4 weeks with 2 weeks follow up |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both the sexes having Age between 30 years to 60 years
Patients having classical symptomatology of Madhumeha (Prabhutamutrata, Avilamutrata etc)
Symptoms of Diabetes (Polyuria, Polydipsia, Polyphagia and Weight loss)
Patients having Blood sugar
Fasting Blood Sugar ≥ 126 mg/dl
Post Prandial Blood Sugar ≥ 200 mg/dl |
|
| ExclusionCriteria |
| Details |
Age below 30 and above 60 years.
Patients of Diabetes Mellitus receiving Insulin.
Malignant and accelerated Hypertension.
Patients having chronic complications of Diabetes Mellitus
a.Microvascular: Retinopathy, Neuropathy, & Nephropathy.
b.Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
c.Other chronic debilitating diseases like STD etc.
5.Pregnant women.
6.Lactating mothers.
7.Secondary Diabetes mellitus.
8.Patients of any other severe illness.
9.Severe Iron deficiency anemia with Hb% less than 7mg/dl
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the trial drugs will exert a significant action over classical symptomatology of Madhumeha (Prabhutamutrata, Avilamutrata) |
up to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It will help to live diabetic patient more healthy and without complications |
Up to 4 weeks |
|
|
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)
|
17/08/2015 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Almost all Rasavarga Dravya are used therapeutically essentially after Shodhana and Marana. Abhraka is one among the drugs which are said to use after proper process of Marana. Abhraka is among Rasavarga dravya for whome maximum number of repetitive cycles of Puta that is 1000 are mentioned in ancient classics on Rasa Shastra. Although Bhasma of Abhraka can be prepared with single Puta, yet 1000 repetitive cycles of Puta are also mentioned for its marana. Abhraka is said to posses Pramehahara property and said to be used in all diseases. It is among few Rasavarga dravya which predominantly have Yogavahi and Rasayana property. In Prameha, 10 dushya gets affected hence drug posseing Rasayana property along with Pramehahara effect would be drug of choice, which Abhraka Bhasma. |