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CTRI Number  CTRI/2017/12/010846 [Registered on: 12/12/2017] Trial Registered Prospectively
Last Modified On: 25/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of Gandhakadi yoga in the management of Thalassemia major 
Scientific Title of Study   A Further Clinical Study On Beejadushtijanya Pandu Thalassemia Major and Its Management with Gandhakadiyoga An Open Labelled Randomized Controlled Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jigna R kalara 
Designation  MD second year 
Affiliation  IPGT AND RA Jamnagar  
Address  Department Of Kaumarbhritya OPD no 24 IPGT and RA GAU Jamnagar
Department Of Kaumarbhritya OPD no 24 IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9408350303  
Fax    
Email  jignakalara27071992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof K S Patel 
Designation  Professor and HOD Kaumarbhritya department ipgt and ra Jamnagar 
Affiliation  IPGT AND RA JAMNAGAR 
Address  Kaumarbhritya department ipgt and Ra Gujarat ayurved university
Kaumarbhritya department ipgt and Ra Gujarat ayurved university
Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr V K Kori 
Designation  Associate Professor IPGT and RA Gujarat ayurved university 
Affiliation  IPGT AND RA JAMNAGAR 
Address  Kaumarbhritya department ipgt and Ra Gujarat ayurved university
Kaumarbhritya department ipgt and Ra Gujarat ayurved university
Jamnagar
GUJARAT
361008
India 
Phone  9374548475  
Fax    
Email  drvkkori@yahoo.co.in  
 
Source of Monetary or Material Support  
Director IPGT and RA GAU Jamnagar 
 
Primary Sponsor  
Name  Director IPGT and RA GAU JAMNAGAR 
Address  IPGT and RA GAU JAMNAGAR 
Type of Sponsor  Research institution and hospital 
 
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 
Jigna R Kalara  PG Hospital IPGT and RA Jamnagar  PG Hospital Kaumarbhritya Department OPD IPGT and RA Jamnagar Gujarat
Jamnagar
GUJARAT 		 9408350303

jignakalara27071992@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 Teaching And Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 PGT/7/-A/Ethics/2017-2018/2093  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pre Diagnosed patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  in Group A Gandhakadi Yoga prepared with Agastya Patra Swarasa Bhavana and Shigru Patra Swarasa Bhavana   Total 4 drugs in Group A Shuddha Gandhaka Sulphur Vidanga Embelia robusta Burm f Agastya patra Sesbaniya grandifoliya Linn Shigru Patra Moringa Oleifera Lam Age of the child 2 to 5 years 6 to 9 years 10 to 12 years Drug Dose 500 mg 1Tablet 700 mg 1and half Tablet) 1 gm 2 Tablets Duration of the therapy:12 weeks(90 days) Mean of dose 1gm 2 Tablets Duration 90 days  
Comparator Agent  In Group B Gandhakadi Yoga prepared with Agastya Patra Swarasa Bhavana   Total 3 drugs in Group B Shuddha Gandhaka Sulphur Vidanga Embelia robusta Burm f Agastya patra Sesbaniya grandifoliya LinnAge of the child 2 to 5 years 6 to 9 years 10 to 12 years Drug Dose 500 mg 1Tablet 700 mg 1and half Tablet) 1 gm 2 Tablets Duration of the therapy:12 weeks 90 days Mean of dose 1gm 2 Tablets Duration 90 days  
Comparator Agent  In Group C Control group  Modern medical management Blood Transfusion 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Age groups 2 to 12 years of either sex
irrespective Religion Caste
2 Diagnosed cases of Thalassemia major
 
 
ExclusionCriteria 
Details  1 Children below 2 years and above 12 years of
age
2 Cases having HIV HBV infection hepatic
failure DM TB
3 Patient having BT interval for less than 12
days
4 Patient undergone Splenectomy
 
 
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 
To Decrease The Days Of Blood Transfusion  12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To Decrease The Days Of Blood Transfusion  12 Weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   12/02/2018 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No any related publication 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Present clinical trial is randomised clinical trial on Beejadushtijanya Pandu (Thalassemia Major) in children of either sex between 2 to 12 years of age. Study will evaluate the role of Gandhakadi Yoga  prepared with Agastya Patra Swarasa Bhavana and Shigru Patra Swarasa Bhavana  and Gandhakadi Yoga prepared with Agastya Patra Swarasa Bhavana Intervational drug is Gandhakadi Yoga  prepared with Agastya Patra Swarasa Bhavana while comparator agent is  Gandhakadi Yoga prepared with Agastya Patra Swarasa Bhavana Study is going to be conducted with primary aim  To decrease the days of blood transfusion. Till date 60 patients will be registered in clinical trial ,As trial as in progress final conclusion or remarks can be drawn only after the completion of clinical trial.

 
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