study on siddha medicine manjal noi kudineer for treating anemia in children

Phase 2

Not yet recruiting

Conditions: Iron deficiency anemia, unspecified,

Registration Number: CTRI/2025/05/086495

Lead Sponsor: National Institute of Siddha

Brief Summary: BACKGROUND: Iron deficiency anemia (ICD -11:3A00, ISMT-4.7.40))is a significant public health problem that occurs worldwide in both developedand developing countries. In 1980, the World Health Organization (WHO)estimated that 700 million people worldwide suffered from anemia and more thantwo billion people worldwide have been affected by it. Approximately 50% ofanemia cases are caused by iron deficiency. Iron deficiency anemia (IDA) isthe most frequent hematological disorder of childhood and adolescence and themost common form of anemia, with an incidence in industrialized countries of20.1% between 0 and 4 years of age and 5.9% between 5 and 14 years (39 and48.1%in developing countries) . It is a hypochromic and microcytic anemiacharacterized by Hb values below the normal range for sex and age, reduced MCV,and MCH. Iron is an essential nutrient for the development of the fetus,infant, and child . The body’s iron content is dependent on its intake andabsorption with nutrition. The homeostasis of this nutrient is determined bythe balance between its uptake and release from the cells where it is storedand recycled . Iron is released into the circulation where it is carriedby the plasma protein transferrin, into the duodenum by enterocytes that absorbdietary iron, and by macrophages which recycle senescent erythrocytes and liverreserves. If iron levels in the body are inadequate, its intestinalabsorption is enhanced [6]; In case of excess, it is stored in the enterocytesas ferritin and the liver, spleen, and bone marrow as hemosiderin. Therelease of free iron ions in the plasma, essential for the maintenance of itshomeostasis, is mediated by ferroportin, whose expression is subordinated tothe activity of hepcidin. WHO criteria for diagnosis of IDA: Age 6 months -6 yrs: less than 11 gms, Age 6 yrs - 14 yrs : less than 12 gms. Mild:Hemoglobin 10.0 g/dL to lower limit of normal. Moderate: Hemoglobin 8.0 to 10.9g/dL. Severe: Hemoglobin 6.5 to 7.9 g/dL. According to the Siddhar Yugi munithe diseases are widely classified into 4448 including Veluppu noi also. Theterm Veluppu denots the pallor of the body. Veluppu is described as a diseasedcondition in which the nature of the body including nail beds and conjunctivabecomes pallor. As per siddha concept Veluppu noi occurs due to excessiveintake of salt and sour taste,fever, vomiting, diarrhoea, worms, liver diseasesand intake of unconsumed items such as soil,ash and camphor. Iron deficiencycauses different abnormalities in the three major population groups that are atrisk. In iron-deficient infants and children, there is convincing evidence ofimpaired psychomotor development and cognitive.I have chosen siddha herbalformulation –Manjal noi kudineer contains Keezhanelli (Phyllanthusamarus,Shum&Thonn), karisalai (Eclipta prostrata,Linn), peipudal(Trichosanthes cucumerina,Linn), venmilagu (Piper cubeba,Linn), Sombu(Foeniculum vulgare,Mill), vilvam (Aegle marmelos,Linn). OBJECTIVE: PRIMARYOBJECTIVE: • To evaluate the efficacy of Manjal noi kudineer in the managementof Paandu noi (IDA) in paediatric population.

OBJECTIVE: PRIMARY OBJECTIVE: • To evaluate the efficacy ofManjal noi kudineer in the management of Paandu noi (IDA) in paediatricpopulation.

STUDY DESIGN: This is an interventional study of Non randomizedsampling which will be carried out for 18 months in patients with hemoglobinlevel of 8.0-10.9 gm reporting at OPD ofAyothidoss Pandithar Hospital , National Institute Of Siddha, Chennai-600047with 30 patients as sample size. Patient with age 3-12 years of both sex.

OUTCOME: PRIMARYOUTCOME:- • Primary outcome of the clinical study will be assessed by increaseof hemoglobin (Hb) level in before &after treatment. • For clinicalsignificance defined as the MCID of hemoglobin (Hb) increase from the baseline.SECONDARY OUTCOME: Reduction of clinical symptoms like malaise, headache,palpitation, lack of concentration during before and after treatment.

RESULT AND DISCUSSION: The result will be statisticallyanalysed and reported.

KEYWORDS: anemia, manjal noi kudineer, hemoglobin.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Hemoglobin level within 8.0-10.9gm.

Exclusion Criteria

Patient with chronic disease Known case of any hematological disorder.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clinical study will be assessed by increase of hemoglobin level in before and after treatment	18 months
Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment.	18 months
For clinical significance defined as the MCID of hemoglobin increase from the baseline.	18 months

Secondary Outcome Measures

Name	Time	Method
Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment.	18 months

Trial Locations

Locations (1): Ayothidoss Pandithar Hospital
🇮🇳
Kancheepuram, TAMIL NADU, India
Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Dr N Sabana yasmine
Principal investigator
9600876457
sabanayasmine2020@gmail.com