| 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
|
|
|
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
|
|
|
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 ,â€Prevention is better than cureâ€. 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. |