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CTRI Number  CTRI/2024/06/068404 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study on Megarajanga Kirutham in the treatment of Azhal Veluppu Noi ( Iron Deficiency Anaemia) 
Scientific Title of Study   Clinical Evaluation of Siddha Herbal Formulation Megarajanga Kirutham in the treatment of Azhal Veluppu Noi ( Iron Deficiency Anaemia) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JOESHPIN LUIESA MARY A  
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  8524802999  
Fax    
Email  jlmdass1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Lakshmi kantham 
Designation  Associate Professor and Head of the Department  
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr T Lakshmi kantham 
Designation  Associate Professor and Head of the Department  
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha,Tambaram sanatorium,Chennai 600047 
 
Primary Sponsor  
Name  National Institute of Siddha  
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha,Tambaram Sanatorium.  
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 
Dr JOESHPIN LUIESA MARY A  Ayothidoss Pandithar Hospital  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU 
8524802999

jlmdass1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Siddha  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  Megarajanga Kirutham   4ml two times a day(after food) for 90 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 less than normal range,(According to WHO criteria,)
For male:9-12gms/dl(Normal : 13gm/d1]For-female:8-11gms/dl(Normal:12gms/d1]
2.Patient willing to undergo blood investigation.
3.Patients who are willing to participate in the study and signing in informed consent form

 
 
ExclusionCriteria 
Details  1.Patient with Cystic fibrosis
2.Patient with Severe Cardiac Diseases
3.Patient with positive Faecal occult blood and haematochezia
4.Inherited blood disorders(Sickle cell anaemia,Thalassemia)
5.Pregnant/Lactating mother
6.Patients not willing to give blood sample
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Haemoglobin level from the baseline and increase in Hb gm% will be considered as Improvement.  12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
The clinical lab parameters including Complete blood count ,Peripheral blood smear , Serum Ferritin, Serum Transferrin and Total Iron Binding Capacity will be assesed.  12 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/07/2024 
Date of Study Completion (India) 01/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

BACKGROUND: Siddha system of medicine is one of the traditional system originated from South India. .The main aim of this system is Prevention of diseases as it is well said ,”Prevention is better than cure”. Siddhars identified 4448 diseases VELUPPU NOI is one among them. As per Siddha literature YUGI VAITHYA CHINTHAMANI 800, increased consumption of salty and sour foods,Chronic affliction from fever, diarrhoea ,vomitting , menorrhagia, haemorrhoids and diseases that cause excessive loss of blood from the body leads to weakening or defeciency of the RAKTHA THATHU ,one of the seven vital thaathus of the body. It is also mentioned that increased consumption of betal leaf, tobacco and ashes may also cause the diesease.Distruption in the Raktha thaathu further leads to weakness,debility,dyspnoea on exertion, loss of appetite ,nausea, palpitations,weightloss and pallor. VELUPPU NOI is classified into 5 types, AZHAL VELUPPU NOI is one among them. According to WHO anaemia is defined as a condition with haemoglobin level less than 7.7mmol/l(13g/dl) in men and 7.4mmol/l (12g/dl) in women. Prevalence of anaemia globally 56% and in India 52% .According to National family health survey ,Anemia is particularly high (55.3%) in 15 to 49years of age. According to American society of haematology. Anemia remains a major health problem especially in developing countries. It is a major concern for many females reporting at the OPD of National Institute of Siddha, who are unaware of it`s frightening complications in the future.Hence I have chosen MEGARAJANGA KIRUTHAM which is purely polyherbal siddha formulation which is cost effective, easy to administer and contains potent herbs with HAEMATINIC,ANTI ANAEMIC AND ANTIOXIDANT activities cited through various research articles(pubmed,webmed,google scholar etc…)as my study drug for the treatment of anemia.   

PRIMARY OBJECTIVE: Clinical Evaluation of Siddha formulation MEGARAJANGA KIRUTHAM in the treatment of AZHALVELUPPU NOI (Iron Deficiency Anaemia) through haemtological investigation of Haemoglobin in Hb gm% before and after treatment.

 SECONDARY OBJECTIVE : Assessment of improvement through other clinical laboratory blood parameters including Complete blood count, Blood smear study, Serum Ferritin level ,Serum Transferrin and Total Iron Binding Capacity (TIBC).

METHODOLOGY : A Total of 30 diagnosed patients of AZHAL VELUPPU NOI ( IRON DEFICIENCY ANAEMIA ) within the age limit of 18 to 60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria .Patient with Cystic fibrosis ,Severe Cardiac Disease , Positive faecal occult blood, Haematochezia ,Inherited blood diseases ( Sickle cell anaemia , Thalassemia ) Pregnant / Lactating mother ,Patients not willing to blood sample will be excluded.
OUTCOME OF TREATMENT :
PRIMARY OUTCOME: Assessment of Haemoglobin level from the baseline and increase in Hb gm% will be considered as Improvement.

SECONDARY OUTCOME:The clinical lab parameters including Complete blood count, Blood smear study, Serum Ferritin level ,Serum Transferrin and Total Iron Binding Capacity (TIBC) will be assesed.

RESULT AND DISSCUSSION : The result will be statistically analysed.

KEYWORDS : Megarajanga Kirutham, Azhal veluppu noi, Iron Deficiency Anaemia.

 
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