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临床试验/CTRI/2024/06/068404
CTRI/2024/06/068404已完成2 期

Clinical Evaluation of Siddha Herbal Formulation Megarajanga Kirutham in the treatment of Azhal Veluppu Noi ( Iron Deficiency Anaemia)

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Assessment of Haemoglobin level from the baseline and increase in Hb gm% will be considered as Improvement.

研究概览

简要总结

**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 NOIis one among them. As per Siddha literature YUGI VAITHYA CHINTHAMANI800, 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 NOIis classified into 5 types, AZHAL VELUPPU NOIis 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 KIRUTHAMwhich 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 Siddhaformulation MEGARAJANGA KIRUTHAMin 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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Assessment of Haemoglobin level from the baseline and increase in Hb gm% will be considered as Improvement.

时间窗: 12 Months

次要结局

  • 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)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

JOESHPIN LUIESA MARY A

National Institute of Siddha

研究点 (1)

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