Efficacy of Herbo-mineral tablet in Iron deficiency anemia in children of 6 to 14 years

Phase 2

Completed

Conditions: Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,

Registration Number: CTRI/2023/09/057763

Brief Summary: Nutritional deficiencies are primarily caused by inadequate dietary intake, increased nutrient loss, impaired absorption, and altered nutrient metabolism. When the concentration of hematopoietic nutrients like iron involved in RBC production or maintenance becomes insufficient to meet the bodyâ€™s needs, nutritional anemia occur. Majority of anemia exists in the form of Iron deficiency anemia (IDA) associated with poor cognitive, physical growth and motor development which affects the school performance in children. Infants, preschool children and adolescents are at greater risk of developing iron deficiency. According to The Fifth National Family Health Survey the prevalence of anemia in 6 to 59 months age group children is 67.1% (Rural -68.3%, Urban â€“ 64.2%) in India and in Karnataka it is 65.5% while that in Mysore and Chamarajanagara district it is 27.6% .The prevalence of anemia is significant in India because the majority of IDA patients come from lower-or middle-class families, particularly in areas where nutrient deficits i.e. diet is predominantly carbohydrate (wheat, rice) based and vegetarian. Worm infestations and infection are frequently encountered in such population too. Clinical manifestations of IDA include pallor, fatigue, dizziness, reduced exercise capacity, irritability, pica and adverse effects on neurodevelopment, growth and immunity. The nearest correlation of Iron deficiency anemia in Ayurveda can be made with Pandu Roga, because of the predominance of Panduta or pallor in the whole body. Pandu is a Pitta Pradhana and Rasa-Raktapradoshaja Vyadhi manifested in five types as per predominance of Dosha.Samanya Lakshana of Pandu as per Kashyapa Samhita are, Nabhyam Samantat Shotha (swelling around umbilicus), Shwetakshi (pallor of eyes), Nakhavakrata (deformity of nails), Agnisada, Nashtagni (loss or reduced digestive capacity), Akshikuta Shotha (Periorbital edema) and Rudhiraspruha (desires for blood as in pica).Line of treatment in Pandu Roga is Samshodhana, Samshamana and Pathya palana. In the contemporary system of medicine, oral iron supplementation is recommended in children suspected with iron deficiency anemia. Ferrous sulphate continues to be the gold standard and the preparation of choice. Acceptable alternatives include ferrous fumarate, gluconate, or ascorbate.Although effective, poor drug compliance stands as a hurdle in continuation of modern treatment. As adverse reactions, gastrointestinal symptoms like nausea, vomiting, abdominal pain, constipation, black feces and diarrhea are also reported frequently. Mandura Vajra Vataka is the drug selected for the present clinical study which has been mentioned in the treatment of Pandu in Chakradatta.It contains herbal drugs which act as Agni Deepana and Pachana due to their hot potency enhances digestion and natural absorption of Iron, Vidanga acts as Krimighna and Musta, Devdaru does Raktaprasadana. Mandura helps in restoring Iron in the body which helps in the management of Pandu roga. Thus, the trial drug concentrates on proper functioning of Agni which is very important for digestion, absorption and assimilation of nutrients to meet the demand of body, and also there is supplementation of Iron (Mandura) in the deficiency state. Hence based upon above references the following study has been designed to understand the role of Mandura Vajra Vataka in Pandu Roga

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Children between the age group of 6 to 14 years irrespective of the gender, caste & socioeconomic status 2.Children having Hb % of 7-10.9 gm% 3.Children presenting with clinical signs and symptoms of Pandu roga and Iron deficiency anemia 4.Peripheral smear showing hypochromic, microcytic anemia 5.Parents /guardians ready to sign informed written consent.

Exclusion Criteria

1.Other known types of anemia like sickle cell anemia, megaloblatic anemia.
2.Other diagnosed severe systemic illness like Severe Acute Malnutrition (SAM), Cerebral palsy, obesity.
3.Known case of Hemorrhagic diathesis like hemophilia, ITP, Vitamin K deficiency.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. comparative reduction in the clinical signs & symptoms of Pandu Roga & IDA at the end of 8 weeks	90 days
2.comparative changes in the values of Hb %, Peripheral smear, serum ferritin & TIBC at the end of 8 weeks	90 days

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (1): JSS Ayurveda Medical College & Hospital,Lalithadripura road, Alanahalli,Mysuru, Karnataka
🇮🇳
Mysore, KARNATAKA, India
JSS Ayurveda Medical College & Hospital,Lalithadripura road, Alanahalli,Mysuru, Karnataka
🇮🇳Mysore, KARNATAKA, India
Dr Gore Snehal Pandurang
Principal investigator
7219183611
snehalgoreayu75@gmail.com