CTRI Number |
CTRI/2015/03/005660 [Registered on: 31/03/2015] Trial Registered Retrospectively |
Last Modified On: |
19/03/2015 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Purpose of the study to know the action of phalendradi yogam with and without yashada bhasma in madhumeha(diabetes) |
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PHALENDRADHI YOGAM WITH AND WITHOUT YASHADA BHASMA IN THE MANAGEMENT OF MADHUMEHA (type 2 D.M). |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr UMA SRINIVAS RAO NEREDU |
Designation |
LECTURER |
Affiliation |
DR B R K R GOVT AYURVEDIC COLLEGE |
Address |
Department of Kayachikitsa
DR BRKR GOVT AYURVEDIC COLLEGE
ERRAGADDA
HYDERABAD Department of Kayachikitsa
DR B R K R GOVT AYURVEDIC COLLEGE ERRAGADDA HYDERABAD
500038. Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9246366104 |
Fax |
|
Email |
dr.nusrao@yahoo.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr UMA SRINIVAS RAO NEREDU |
Designation |
LECTURER |
Affiliation |
DR B R K R GOVT AYURVEDIC COLLEGE |
Address |
Department of Kayachikitsa
DR BRKR GOVT AYURVEDIC COLLEGE
ERRAGADDA
HYDERABAD Department of Kayachikitsa
DR B R K R GOVT AYURVEDIC COLLEGE ERRAGADDA HYDERABAD
500038. Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9246366104 |
Fax |
|
Email |
dr.nusrao@yahoo.in |
|
Details of Contact Person Public Query
|
Name |
Dr UMA SRINIVAS RAO NEREDU |
Designation |
LECTURER |
Affiliation |
DR B R K R GOVT AYURVEDIC COLLEGE |
Address |
Department of Kayachikitsa
DR BRKR GOVT AYURVEDIC COLLEGE
ERRAGADDA
HYDERABAD DR B R K R GOVT AYURVEDIC COLLEGE ERRAGADDA HYDERABAD
500038. Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9246366104 |
Fax |
|
Email |
dr.nusrao@yahoo.in |
|
Source of Monetary or Material Support
|
DR BRKR GOVT AYURVEDIC COLLEGE HOSPITAL,Erragada,Hyderabad,Telangana state-500038 |
|
Primary Sponsor
|
Name |
Dr BRKR Govt Ayurvedic College |
Address |
ERRAGADDA
HYDERABAD |
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 UMASRINIVAS RAO NEREDU |
Department of Kayachikitsa, Room no 3 |
DR BRKR GOVT AYURVEDIC COLLEGE
ERRAGADDA
HYDERABAD Hyderabad ANDHRA PRADESH |
9246366104
dr.nusrao@yahoo.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutinal Ethical Committee Dr B R K R Govt Ayurvedic College Hyderabd |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Type 2 Diabetes Mellitus, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Phalendradi Yogam |
orally 5 gms bid for 3 months |
Comparator Agent |
Phalendradi Yogam with Yashada Bhasma |
Orally 5.6 gm bid for 3 months |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Subjectsbetween the age of 30-60 years
2) Subjects suffering with DM type 2
3) Subjects intrested in treatment for Diabetes. |
|
ExclusionCriteria |
Details |
Who are suffering with madumeha more than 10 years
Madhumeha with other serious complications
Serum creatinine >1.5 albuminurea > 40 Ug/min |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Blood sugar levels will be in normal limits |
Within 90 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improved quality of life and blood sugar levels will be in normal levels |
Within 90 days |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/08/2015 |
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="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Study outcome will be published in peer reviewed generals |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Diabetes is global epedemic according to WHO reports India tops the world capital for Diabetes. By 2025 approximately 55 million Indians will be affected by Diabetes.
Knowledge of Madhumeha is available since vedic period itself. Madhumeha finds its clear mentioning in the ancient books of Charaka Samhitha, Susrutha Samhitha, Astangahridaya, and Bavaprakasha.
Despite the introduction of hypoglycemic agents from natural and synthetic sources, diabetes and its secondary complications continue to be a major medical problem.Many indigenous Indian medicinal plants have been found to be useful to sucessfully manage diabetes.One of the great advantage of medicinal plants is that these are readily available and have no side effects World Health Organisation(WHO) has suggested the evaluation of the potential of the plants as effective therapeutic agents,especially in areas in which we lack of safe modern drugs. The "PHALENDRADI YOGAM" will contain 1.Phalendra Syzygium Cumini (Seeds) 2.Mesha shrungi Gymnema sylvestre (Leaf) 3.Haridra Curcum olonga (Rhizome) 4.Amlaki Emblica officinails (Fruit) 5.Kalamegh Andrographis Panniculata (Whole Plant) 6.Yashada Bhasma (Zinc oxide(zno)) However,there is no comprehensive analysis and this drugs have not been scientifically validated in the treatment of madhumeha thats why i have taken for the study. |