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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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