| CTRI Number |
CTRI/2013/12/004200 [Registered on: 10/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
EFFECT OF MAKARADHWAJA ON DIABETESE (MADHUMEHA) |
|
Scientific Title of Study
|
A STUDY ON TWO SAMPLES OF SHADGUNA MAKARADHWAJA AND THEIR COMPARATIVE EFFECTS ON TYPE-II DM (MADHUMEHA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAIBHAV CHARDE |
| Designation |
MD SCHOLAR |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Dept of RS and BK
Institute for Post Graduate Teaching and
Research in Ayurveda
GAU
Jamnagar 361008
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9723153948 |
| Fax |
|
| Email |
vaibhavayudoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof PK Prajapati |
| Designation |
Prof. and Head |
| Affiliation |
IPGT AND RA |
| Address |
Dept of RS and BK
Institute for Post Graduate Teaching and
Research in Ayurveda
GAU
Jamnagar
GUJARAT
361008
India |
| Phone |
9428315733 |
| Fax |
2882676856 |
| Email |
prajapati.pradeep1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof PK Prajapati |
| Designation |
Prof. and Head |
| Affiliation |
IPGT AND RA |
| Address |
Dept of RS and BK
Institute for Post Graduate Teaching and
Research in Ayurveda
GAU
Jamnagar
GUJARAT
361008
India |
| Phone |
9428315733 |
| Fax |
2882676856 |
| Email |
prajapati.pradeep1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda 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 |
| VAIBHAV CHARDE |
Institute for Post Graduate Teaching and Research in Ayurveda |
Department of RS and
BK Institute for Post
Graduate Training and
Research in Ayurved
GAU Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9723153948
vaibhavayudoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Institute for Post Graduate Training and Research in Ayurved GAU Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A treated with Makaradhwaja prepared by Swarna Varkha
|
dose 14.63 mg along with Guduchi Ghana 235.37 mg orally twice a day
Anupan Madhu.
Duration:4 weeks |
| Comparator Agent |
Group B:treated with Makardhwaja prepared by talastha Swarna Bhasma |
dose 14.63 mg along with Guduchi Ghana 235.37 mg orally twice a day
Anupan Madhu.
Duration:4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Patients having classical symptomatology of Madhumeha (Type II D.M.)
•Symptoms of Diabetes (Polyuria, Polydypsia, Polyphagia and Weight loss.)
•Fasting plasma glucose ≥ 126 mg/dl and Post prandial glucose level ≥ 200 mg/dl.
|
|
| ExclusionCriteria |
| Details |
•Patients of Diabetes Mellitus receiving Insulin.
•Patients having chronic complications of Diabetes Mellitus
1.Microvascular: Retinopathy, Neuropathy, & Nephropathy.
2.Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
3.Other chronic debilitating diseases like STD,TB,Leprosy .
|
|
|
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 |
•Blood sugar level will be monitered with glucometer every week.
•Improvement in the signs and symptoms of the disease as per Ayurvedic texts.
•Investigations conducted before and after the treatment.
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
diseaseProgress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2013 |
| Date of Study Completion (India) |
31/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2014 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study a comparative clinical trial of Shadguna Makaradhwaja will be studied on patients of Type II D.M. (Madhumeha) with Guduchi Ghanna and Madhu as adjuvants.Selected patients will be randomly divided into two groups,Group A: 14.63 mg Makardhwaja prepared by Swarna Varkha + 235.37 mg Guduchi Ghana tablet – bd, orally with Madhu.Group B: 14.63 mg Makardhwaja prepared by talastha swarna bhasma + 235.37 mg Guduchi Ghana tablet – bd, orally with Madhu. for a duration of 4 weeks.Patients will be reviewed after 7 days for a period of 4 weeks.Blood sugar level will be monitered every week.patients will be redirected to regular OPD treatment after the stipulated time of research work. |