To Assess the Efficacy of Mandurvatak and Panchtiktghrit Matra Basti in Pandu with special reference to Iron Deficiency Anaemia An Open Randomized clinical controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the changes in haemoglobin level by Mandurvatak alone or in combination with panchtiktghrit matra basti in comparison with Ferrous Sulphate.
研究概览
简要总结
The primary purpose of this study is to evaluate and compare the efficacy of Mandurvatak an Ayurvedic herbo-mineral formulation alone and in combination with Panchtiktghrit Matra Basti in the management of Pandu Roga (Iron Deficiency Anaemia). The study aims to assess improvements in haemoglobin levels, iron indices, and clinical symptoms while also monitoring any gastrointestinal side effects in comparison with conventional therapy.
This open randomized controlled clinical trial includes three groups:
- Group A (Control Group): Ferrous Sulphate 200 mg daily.
- Group B (Trial Group 1): Mandurvatak ½ Karsha daily orally.
- Group C (Trial Group 2): Mandurvatak ½ Karsha daily orally combined with Panchtiktghrit Matra Basti (60 ml for 11 days in each month).
Each group will be treated for three months with regular monthly follow-ups to evaluate both clinical and haematological outcomes.
Study Hypothesis: Mandurvatak alone or in combination with Panchtiktghrit Matra Basti significantly improves haemoglobin concentration and iron metabolism in patients with Pandu (Iron Deficiency Anaemia) compared to conventional Ferrous Sulphate therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Hb between 7 to 11.5 mg/dl in female and 7 to 13.5 mg/dl in male.
- •Sr.Ferritin less than 15 ng/ml in female and less than 30 ng/dl in male.
- •Sr.iron less than 50 ug/L TIBC greater than 250 ug/L Pt who withdraw from oral or parental iron therapy.
排除标准
- •K/C/O Thalassemia/Aplastic Anaemia/sickle cell Anaemia/Megaloblastic Anaemia.
- •K/C/O any haemorrhagic disorder i.e. active bleeding.
- •K/C/O any systemic disorder i.e.cardiac/ renal/ hepatic/endocrine disorders.
- •K/C/O Immune compromised patients or subjects of Immune suppressive drug.
- •Helminthic infestation(H/o presence of helminithic in stool routine examination) Pregnancy and Lactation.
- •Acute life threatening condition.
结局指标
主要结局
To assess the changes in haemoglobin level by Mandurvatak alone or in combination with panchtiktghrit matra basti in comparison with Ferrous Sulphate.
时间窗: Assessment on 0th 30th 60th 90th days.
次要结局
- To monitor and compare the gastrointestinal side effects of all three groups.(Assessment on 0th 30th 60th 90th days.)
研究者
Dr Nisha Rathod
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College.