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临床试验/CTRI/2024/07/071428
CTRI/2024/07/071428已完成4 期

Efficacy of Sharbat Maweez in the management of soo ul qiniya bawajahe qillat e faulad (Iron deficiency anemia) an open randomised standard control study

Dr Sabeeh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Improvement in Hb% PCV MCH MCHC

研究概览

简要总结

Anemia is the abnormal reduction in the number of circulating RBC, the quantity of hemoglobin, and the volume of packed red cells in a given unit of blood resulting in lower ability for the blood to carry oxygen to body tissues. Iron deficiency is the commonest cause of anemia, especially in developing countries where a sizeable percentage of population is anaemic. Iron is essential for multiple metabolic processes including oxygen transport, DNA synthesis and electron transport. Iron deficiency can also result in diminished growth and learning. According to National Family Health Survey NFHS4 data, the incidence of anemia in urban children is 55.9%, rural is 59.4% and overall is 58.4%. According to WHO definition of anemia, children of 6 months to 5 years with hemoglobin <11 gm/dl, 5 years to 11 years with hemoglobin <11.5gm/dl, 12 years to 14 years with hemoglobin <12gm/dl,15years to 19 years girls with hemoglobin <12gm/dl and boys with hemoglobin <13gm/dl are considered anemic. Pregnant females with hemoglobin <11gm/dl, non pregnant females with hemoglobin <12gm/dl and adult males having hemoglobin <13gm/dl are considered anemic. Iron need is maximum in the period of infancy and childhood. Iron deficiency at this age can result in neurodevelopmental and cognitive deficits which may not be reversible. Iron deficiency also makes the children susceptible for infection, seizures, breath holding spells in children and exacerbations of restless legs syndrome in adults. Iron deficiency can arise either due to inadequate intake, poor bio-availability of dietary iron. Anemic patients particularly children are at high risk of long term impairment of mental or motor development, low IQ level, lack of concentration and decreased physical activity. Iron tablets and syrups have certain side effects such as abdominal cramping, nausea, constipation, dark and hard stool. Now attention is focused on herbal drugs due to their variable role in anemia with no or negligible side effects and cost effectiveness. Therefore the search for efficient and safe medications for the treatment of anemia is of utmost importance.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Hb less than 12g/dl Patients suffering from worm infestation shall be de wormed first after that they will be included in the study.

排除标准

  • Severe anemia Hb less than 6 gm % Indication for blood transfusion Patient with any other type of anemia Thalassemia Sickle cell anemia Patients suffering from internal and external active bleeding chronic or critical illness, any systemic disease e.g. Valvular heart disease Congenital heart disease Renal failure Malignancy Pulmonary Tuberculosis Mental impairment Patients who fail to follow up Patients who fail to give consent.

结局指标

主要结局

Improvement in Hb% PCV MCH MCHC

时间窗: Improvement in Hb% PCV MCH MCHC assess at every 14th day for 8 weeks

次要结局

  • Improvement in decrease appetite weakness palpitation dyspnea on exertion(Improvement in decrease appetite weakness palpitation dyspnea on exertion assess at every 14th day for 8 weeks)

研究者

发起方
Dr Sabeeh
申办方类型
Other [(self)]
责任方
Principal Investigator
主要研究者

Dr Sabeeh

State Unani Medical College and HAHRDM Hospital

研究点 (1)

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