A clinical evaluation of siddha drug "Chitramutti Nei" (Internal) in the treatment of Azhal Pandu (Iron deficiency anemia)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome is mainly assessed by comparing the pre and post treatment Hemoglobin level, of the trial patient.
研究概览
简要总结
It is a single non randomized open - label trial to determine the efficacy and safety of Chitramutti nei in patients with Azhal Pandu (Iron deficiency Anemia). In this trial 40 Iron deficiency Anemia patients will be recruited and the trial drug will be administered 4 ml twice a day along with hot water for a period 45 days. During the study period all the study related data will be recorded and documented in a separate trail master file for each patients. During the trial period if any adverse effect will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD and IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in Indian Journal of Medical Research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Hb level less than normal range, For male : 7-12gms/d1{13-18gms/d1}.
- •For female :7-11gms /d1{11.5-16.5gms/d1}.
- •Patient willing to undergo blood investigation.
- •Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48days but can opt out of the trial of his/her own conscious discretion.
排除标准
- •Hypertension.pregnancy and lactation.
- •presence of any associated severe systemic illness.(e.g. CA,RA) Endocrine disorder(Thyroid abnormality,Diabetes mellitus) Cardiac disease.Renal disease.Inherited defects (sickle cell anemia, Thalassemia,Aplastic anemia) Patient not willing to give blood sample.
- •Epilepsy.Worm infestation.
结局指标
主要结局
Primary outcome is mainly assessed by comparing the pre and post treatment Hemoglobin level, of the trial patient.
时间窗: 45 days
次要结局
- Secondary outcome is assessed by comparing the following parameters,before and after the treatment.reduction of clinical symptoms.changes in complete blood count.changes in serum ferritin level(45 days)