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CTRI Number  CTRI/2018/02/012256 [Registered on: 28/02/2018] Trial Registered Prospectively
Last Modified On: 30/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To evaluate The Effect Of Murvadya Choorna Vati In Pandu Vyadhi (Iron Deficiency Anaemia”)  
Scientific Title of Study   An Open Labelled, Single Arm Study To Evaluate The Efficacy Of Murvadya Choorna Vati In Pandu Vyadhi W.S.R. To Iron Deficiency Anaemia 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR YOGESH T KOTANGALE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Maharashtra Arogya Mandal, Sumatibhai Shah Ayurved college 
Address  OPD NO 2 First Floor Kayachikitsa Department Sane Guruji Arogya Kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028
OPD NO 2 AND IPD First and second floor Kayachikitsa Department Sane Guruji Arogya Kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India 
Phone    
Fax    
Email  drytk@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  DR YOGESH T KOTANGALE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Maharashtra Arogya Mandal, Sumatibhai Shah Ayurved college 
Address  OPD NO 2 First Floor Kayachikitsa Department Sane Guruji Arogya Kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028

Pune
MAHARASHTRA
411028
India 
Phone    
Fax    
Email  drytk@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR TANVI METKARI 
Designation  PG SCHOLAR 
Affiliation  Maharashtra Arogya Mandal, Sumatibhai Shah Ayurved college 
Address  OPD NO 2 First Floor Kayachikitsa Department Sane Guruji Arogya Kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028

Pune
MAHARASHTRA
411028
India 
Phone  9881239333  
Fax    
Email  tanvimetkari@gmail.com  
 
Source of Monetary or Material Support  
self OPD NO 2 First Floor Kayachikitsa Department Sane Guruji Arogya Kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028  
 
Primary Sponsor  
Name  Self 
Address  OPD NO 2 First Floor Kayachikitsa department Sane guruji arogya kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028 
Type of Sponsor  Private 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 Yogesh Tukaram Kotangale  Saneguruji Arogya kendra  OPD NO 2 First Floor Kayachikitsa department Sane guruji arogya kendra M.A.M.S Sumatibhai Shah Ayurved college, Malwadi, Hadapsar Pune 411028
Pune
MAHARASHTRA 		 9423218193
9423218193
drytk@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  The patients having symptoms of Iron Deficiency Anaemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Murvadya Choorna Vati  Dose: 2 gms Twice a day Kala: Morning and evening Anupana: Luke warm water Duration: 45 days Follow up every 15th day 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Pandu Vyadhi will be diagnosed according to subjective & objective parameters.
2. Age : 18-60 Yrs. Irrespective of gender, religion, socio-economic status, marital status
3. Hb % more than 8 gm% & less than normal i.e. Male -<13g / dl, Female –
< 12g / dl
 
 
ExclusionCriteria 
Details  1. Endocrine disorders like hypothyroidism, Cushing syndrome, etc.
2. Pregnant and lactating lady.
3. Patient having tuberculosis, known case of HIV, leprosy, any type of Cancer.
4. Patients showing signs and symptoms of internal bleeding, hemorrhoids, menorrhagia or any other bleeding disorder. (Worms, scurvy, puerperal etc.)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Study the effect of Murvadya Choorna Vati on clinical symptoms and hematological parameters of Pandu Vyadhi.  45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Murvadya Choorna Vati in Pandu Vyadhi on the basis of change in Haemogram i.e. Hb%, RBC count, MCV, MCH, MCHC, HCT, RDW, Sr. Iron level and TIBC and clinical symptoms also.  45 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) 31/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

“An open labelled, single arm study to evaluate the efficacy of murvadya choorna vati in Pandu Vyadhi W.S.R. to iron deficiency anaemia”. The prevalence of Anaemia in 2016 is estimated at  9% in high developed country and 43% in developing country.  The aim of the trial is to study the efficacy of Murvadya Choorna Vati in Pandu Vyadhi with special reference to Iron Deficiency Anaemia. The objectives are to evaluate the effect of Murvadya Choorna Vati in Pandu Vyadhi  on the basis of change in Haemogram i.e. Hb%, RBC count, MCV, MCH, MCHC, HCT, RDW, Sr. Iron level and TIBC and clinical symptoms also.

 
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