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CTRI Number  CTRI/2019/05/019214 [Registered on: 20/05/2019] Trial Registered Prospectively
Last Modified On: 16/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on Karisalai mathirai for Pitha paandu (Iron deficiency Anaemia) 
Scientific Title of Study   A prospective open labelled , Non-randomized ,phase II clinical trial of Karisalai mathirai in the management of Pitha paandu (Iron deficiency Anaemia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A Karthick 
Designation  PG scholar 
Affiliation  Govt Siddha Medical college  
Address  II year PG Scholar Department of Pothu Maruthuvam Govt Siddha Medical college Palayamkottai Tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9042516331  
Fax    
Email  draskarthick@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Manoharan MD Ph D  
Designation  Professor and HOD 
Affiliation  Govt Siddha Medical college and hospital Palayamkottai Tirunelveli 
Address  Department of Pothu Maruthuvam Govt Siddha Medical college and hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443886700  
Fax    
Email  drmanoharan25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr G SubashChandran MD PhD 
Designation  Lecturer grade II 
Affiliation  Govt Siddha Medical college and hospital Palayamkottai Tirunelveli 
Address  Department of Pothu Maruthuvam Govt Siddha Medical college and hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443358271  
Fax    
Email  siddhadrgs21@gmail.com  
 
Source of Monetary or Material Support  
IPD and OPD facilities and central library of Govt Siddha Medical College and Hospital, Palayamkottai 
 
Primary Sponsor  
Name  Govt Siddha Medical College and Hospital 
Address  Palayamkottai, Tirunelveli Tamil nadu 627002  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
A KARTHICK  Govt Siddha Medical College and Hospital  OP no 10 PG Department of Pothu Maruthuvam Govt Siddha Medical College and Hospital Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU 
9042516331

draskarthick@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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  KARISALAI MATHIRAI  1-2 Tablet BD A/F along With Butter Milk for 45 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Hb level between 7.1 - 10 grams
2. Pallor of skin , mucous membrane, conjuctiva, nailbeds
3. Fatigue, shortness of breath, palpitation
4. Anorexia
5.Blood loss due to menstrual disorders,hemorrhoids and peptic ulcer  
 
ExclusionCriteria 
Details  1. Congenital heart disease
2. Patients with chronic renal disease
3. Liver disease
4.Inherited hemolytic defects
5.Thalassemia
6. Thyroid disease
7.Diabetes mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Relief of clinical symptoms mentioned in inclusion criteria
2. Increase in HB level
3. Improvement in lab parameters 
45 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Evaluation of heamatinic activity of trial drug
2. Evaluation of additional effects and changes of siddha parameters in Pitha Paandu
3.Evaluation of safety profile, Biochemical and pharmacological parameters of trial drug. 
45 days 
 
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 2 
Date of First Enrollment (India)   21/05/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is a prospective open labelled ,non- randomized , phase II clinical study to evaluate the therapeutic efficacy of KARISALAI MATHIRAI in the management of Pitha Paandu(iron deficiency aneamia). The trial drug will be administered at the dose of 1-2 tablets BD A/F along with Butter milk for 45 days in 60 patients . The trial period of 12 months will be carrying out in Govt Siddha Medical College and Hospital,  Palayamkottai , Tirunelveli ,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug KARISALAI MATHIRAI. The secondary outcome will be evaluation of Siddha diagnostic parameters , assessment of safety profile, pharmacological and biochemical parameters of trial drug. 
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