A randomized standard control clinical study to evaluate the efficacy of Mandura Vajra Vataka versus oral iron supplementation in Iron deficiency anemia Vis-A-Vis Pandu Roga in children.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. comparative reduction in the clinical signs & symptoms of Pandu Roga & IDA at the end of 8 weeks
研究概览
简要总结
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 body’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 – 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. comparative reduction in the clinical signs & symptoms of Pandu Roga & IDA at the end of 8 weeks
时间窗: 90 days
2.comparative changes in the values of Hb %, Peripheral smear, serum ferritin & TIBC at the end of 8 weeks
时间窗: 90 days
次要结局
- Not applicable(Not applicable)
