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CTRI Number  CTRI/2018/05/014111 [Registered on: 25/05/2018] Trial Registered Prospectively
Last Modified On: 21/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of safety and therapeutic efficacy of siddha drug "KANDAAMALAGA ILAKAM" in the treatment of Iron deficiency anaemia. 
Scientific Title of Study   Evaluation of safety and therapeutic efficacy of a siddha herbomineral formulation "KANDAAMALAGA ILAKAM" (Internal) in the treatment of AZHAL VELUPPU NOI (Iron deficiency anaemia)  
Trial Acronym  KANDAAMALAGA ILAKAM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTNivetha 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Maruthuvam National Institute of siddha Tambaram Sanatorium
Department of Maruthuvam National Institute of siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  8883176663  
Fax  04422381314  
Email  nivetha888666@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKManickavasagam 
Designation  Head of the department 
Affiliation  National Institute of Siddha 
Address  Department of Maruthuvam National Institute of siddha Tambaram Sanatorium
Department of Maruthuvam National Institute of siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9444249798  
Fax  04422381314  
Email  dr.kmvm@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrHVetha Merlin Kumari 
Designation  Lecturer 
Affiliation  National Institute of Siddha 
Address  Department of Maruthuvam National Institute of siddha Tambaram Sanatorium
Department of Maruthuvam National Institute of siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax  04422381314  
Email  dr.vetha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha Tambaram Sanatorium Chennai 47 
 
Primary Sponsor  
Name  Ayothidoss Pandithar Hospital 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 47 
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 
DrTNivetha  Ayothidoss Pandithar Hospital  Room No 1 Department of Maruthuvam National institute of siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU 		 8883176663
04422381314
nivetha888666@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee National Institute of Siddha Tambaram Sanatorium  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients complaints with pallor of skin and mucus membrane, fatigue, lassitude,chest discomfort, breathlessness,pica,giddiness,dizziness,angular stomatitis, pungent or bitter taste.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  kandaamalaga ilakam  4 gms of kandaamala ilakam will be given thrice a day along with warm water for a period of 45 days  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Hb level less than normal range, For male:7-10gms/dl(normal:13-18gms/dl),For female:7-10gms/dl(normal:11.5-16.5), patient willing to undergo blood investigation, patient who are willing to participate in study and signing in informed consent form.  
 
ExclusionCriteria 
Details  Hypertention, presence of any associated severe systemic illness (Eg.cancer, rheumatoid), Endocrine disorder( thyroid abnormality, diabetes mellitus), severe cardiac disease,Inherited defects(sickle cell Anemia, Thalassemia, Aplastic anaemia), patient not willing to give blood sample  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is mainly assessed by comparing the pre, mid and post treatment heamoglobin level of the study patient.  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
secondary outcome is assessed by comparing the following parameters, before and after the treatment, Reduction of clinical symptoms, changes in complete blood count, changes in iron supply studies.  45 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/07/2018 
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="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   It is a single non randomized open - label trial to evaluate the safety and therapeutic efficacy of kandaamalaga ilakam (internal) in Azhal veluppu noi( Iron deficiency anaemia) patients. In this trial 30 Iron deficiency  anaemia patients will be recruited and the trial drug will be administered 4 gms thrice a day along with warm water for 45 days. During the study period all the study related data will be recorded and documented in a separate trial  master file for each patients. During the trial period if  any adverse effect will be noticed and referred to pharmacovigilance department in National institute of siddha and further management will also be given in national institute of siddha OPD and IPD. The entire trial will be monitored by the research monitoring committee of national institute of siddha. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. the outcome of this trial will be published in the Indian  journal of medical research.    
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