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CTRI Number  CTRI/2019/09/021397 [Registered on: 24/09/2019] Trial Registered Prospectively
Last Modified On: 15/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Research study in Amravati Municipality school going children of age 12 to 14 to assess the effect of an Ayurvedic Herbo-mineral formulation in Anemia.  
Scientific Title of Study   Evaluation of Efficacy of Charakokta Ksharagad by Open Labelled Randomized Controlled Clinical Trial in the Management of Pandu (Iron Deficiency Anemia) in Municipality School Going Adolescents in Amravati City.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krantikumar D Amaley 
Designation  Associate Professor 
Affiliation  Vidarbha Ayurved Mahavidyalaya, Amravati 
Address  Vidarbha Ayurved Mahavidyalaya, Dhanwantari nagar, Chhatri Talao road, Amravati

Amravati
MAHARASHTRA
444606
India 
Phone  9923757231  
Fax    
Email  krantikumar.amaley@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay H Patkar 
Designation  Professor and Head 
Affiliation  ASS Ayurved Mahavidyalaya Nashik 
Address  ASS AyurveD Mahavidyalaya Ganeshwadi Panchavati Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8007431099  
Fax    
Email  drabhaypatkar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Krantikumar D Amaley 
Designation  Associate Professor 
Affiliation  Vidarbha Ayurved Mahavidyalaya, Amravati 
Address  Vidarbha Ayurved Mahavidyalaya, Dhanwantari nagar, Chhatri Talao road, Amravati

Amravati
MAHARASHTRA
444606
India 
Phone  9923757231  
Fax    
Email  krantikumar.amaley@yahoo.com  
 
Source of Monetary or Material Support  
ASS AYURVED COLLEGE GANESHWADI PANCHAVATI NASHIK 422003 
 
Primary Sponsor  
Name  ASS Ayurved College 
Address  Ganeshwadi Panchavati Nashik 422003 
Type of Sponsor  Other [[Grant in aid Ayurveda 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 Krantikumar D Amaley  VIDARBHA AYURVED RUGNALAYA, AMRAVATI  OPD No. 11, Department of Kaumarbhritya, Dhanwantari nagar, Chhatri Talao road, Amravati-444606
Amravati
MAHARASHTRA 		 9923757231

krantikumar.amaley@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of ASS Ayurved College Nashik  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 
Comparator Agent  Ferrous Sulphate  60 mg elemental iron daily before meal with water for 45 days.  
Intervention  ksharagad   2 pills of 250 mg twice daily before meal with water for 45 days.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  subjects having classical symptoms of pandu that is iron deficiency anemia and hemoglobin level ranging from 8 to 11.9 g/dl at the time of screening After obtaining written informed consent from the parents/guardian subjects will be included in the study.
 
 
ExclusionCriteria 
Details  1. Subject Age less than 12 yrs and greater than 14 yrs.
2.Hemoglobin less than 8g/dl that is of severe anemia.
3.known cases of Anemia due to excessive blood destruction e.g. Thalassaemia, Sickle cell anemia and haemolytic anemia.
4.known case of Megaloblastic anemia.
5.known cases of Anemia due to blood loss such as menorrhagia, GI loss etc.
6.known cases of Anemia secondary to chronic systemic disorders e.g. due to infection, rheumatoid arthritis, chronic renal & liver disease and widespread malignant disease.
7.Any critical illness.
8.Subjects and their parents not willing to participate in the study.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increase in Hemoglobin %  at the end of 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of the disease described in ayurvedic classics & modern literature.  after every 15 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 3 
Date of First Enrollment (India)   18/11/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Current study is open labeled, two arms, Randomized Controlled Clinical Trial. Purpose of the Study: Nutritional anemia is a major public health problem in India and is primarily due to iron deficiency. Anemia especially affects women of reproductive age and young children. Adolescents (age 10–19 years) are at high risk of iron deficiency and anemia. Especially girls, particularly those between the age of 12–15 years, are more vulnerable to iron deficiency mainly because requirements are at a peak. As Iron deficiency anemia is a very common prevalent disease in the society and the side effects of oral allopathic iron preparations are very common, therefore to get a better alternative, it is a need of hour to gather a clinical data regarding the efficacy of an ayurvedic herbo-mineral medicine ‘ksharagad’ vati in Pandu(iron deficiency anemia). With the aim that herbo-mineral medicine Ksharagad vati may be effective to manage iron deficiency anemia in adolescents without any side effects.
 As the previous researcher establishes that some of the content of ksharagad isolately shows hematinic actions, therefore we have decided to study the properties of herbo-mineral compound ‘Ksharagad’ as a whole by using both Ayurvedic parameters and principles as well as Modern parameters (laboratory analysis) to evaluate its efficacy in other disorders like anemia and effective, strong and potent drug to be used by physician in future in the specialty other than its ancient use in toxicology on the basis of its newly defined properties. Hence it is decided to evaluate the effect of Ksharagad vati in the management of iron deficiency anemia in adolescents.

 
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