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CTRI Number  CTRI/2020/09/027656 [Registered on: 08/09/2020] Trial Registered Prospectively
Last Modified On: 22/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of bibhitakadi vatak and dhatri lauha in pandu roga w.s.r iron deficiency anaemia 
Scientific Title of Study   A comparative study of bibhitakadi vatak and dhatri lauha in the management of pandu roga w.s.r to iron deficiency anaemia in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Seema 
Designation  MD Scholar 
Affiliation  Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur, Rajasthan. 
Address  Room no.154 Department of Kaumarbhritya,Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University college, Karwar, Jodhpur, Rajasthan.
Room no.154 Department of Kaumarbhritya,Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University college, Karwar, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342037
India 
Phone  7726964112  
Fax    
Email  sanjay.seema32@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish Kumar Singhal 
Designation  Assistant Professor 
Affiliation  Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur, Rajasthan. 
Address  Room no.153 P.G.Depatment of Kaumarbhritya,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University college, Karwar, Jodhpur, Rajasthan.
Room no.153 P.G.Depatment of Kaumarbhritya,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University college, Karwar, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342037
India 
Phone  9636622206  
Fax    
Email  drharish_md@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Seema 
Designation  M.D. Scholar 
Affiliation  Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur, Rajasthan.  
Address  Room no.154 P.G.Depatment of Kaumarbhritya,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University college, Karwar, Jodhpur, Rajasthan.
Room no.154 P.G.Depatment of Kaumarbhritya,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University college, Karwar, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342037
India 
Phone  9636622206  
Fax    
Email  sanjay.seema32@gmail.com  
 
Source of Monetary or Material Support  
Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur, Rajasthan. 
 
Primary Sponsor  
Name  UCA DRSRRAU Karwar Jodhpur Rajasthan  
Address  U.C.A., DR.S.R.R.A.U., Karwar, Jodhpur, Rajasthan  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Seema   Indoor and Outdoor ,University Hospital of Ayurveda.  P.G.Department of Kau marbhritya,Dr.Sarvepall i Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN 		 7726964112

sanjay.seema32@gmail.com 
Dr Seema   Magra Punjala, Jodhpur  OPD of Kaumarbhritya,Kaniram Salgram Satellite Ayurved Hospital, Magra Punjala, jodhpur
Jodhpur
RAJASTHAN 		 7726964112

sanjay.seema32@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bibhitakadi vatak  Dose- 10 ml per kg body weight. Frequency- twice daily. Mode of administration- oral. Duration- 60 days  
Comparator Agent  Dhatri lauha  Dose- 10 ml per kg body weight. Frequency- twice daily. Mode of administration- oral. Duration - 60 days  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patient having Hb% ranging from 7 gm% to 10gm%
Patient show cardinal features of anaemia will be selected 
 
ExclusionCriteria 
Details  Patient below 1 year of age group and patient above 16 years of age group
Hereditary conditions like thalassemia, aplastic anaemia, sickle cell anaemia also will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Maintain level of haemoglobin  60 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   15/09/2020 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This is a randomized, double blind, parallel group trial comparing the efficacy of bibhitakadi vatak and dhatri lauha for 60 days on 40 patient of pandu roga. The primary outcome measures will be relief in sign and symptoms of pandu roga. The secondary outcome will be  maintain of normal haemoglobin level.
Group categorization-
Group- A
Group- B
Each group having 20 patient.
 
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