Evaluation of safety and therapeutic efficacy of a siddha herbomineral formulation "KANDAAMALAGA ILAKAM" (Internal) in the treatment of AZHAL VELUPPU NOI (Iron deficiency anaemia)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome is mainly assessed by comparing the pre, mid and post treatment heamoglobin level of the study patient.
研究概览
简要总结
It is a single non randomized open - label trial to evaluate the safety and therapeutic efficacy of kandaamalaga ilakam (internal) in Azhal veluppu noi( Iron deficiency anaemia) patients. In this trial 30 Iron deficiency anaemia patients will be recruited and the trial drug will be administered 4 gms thrice a day along with warm water for 45 days. During the study period all the study related data will be recorded and documented in a separate trial master file for each patients. During the trial period if any adverse effect will be noticed and referred to pharmacovigilance department in National institute of siddha and further management will also be given in national institute of siddha OPD and IPD. The entire trial will be monitored by the research monitoring committee of national institute of siddha. 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 the 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
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Hb level less than normal range, For male:7-10gms/dl(normal:13-18gms/dl),For female:7-10gms/dl(normal:11.5-16.5), patient willing to undergo blood investigation, patient who are willing to participate in study and signing in informed consent form.
排除标准
- •Hypertention, presence of any associated severe systemic illness (Eg.cancer, rheumatoid), Endocrine disorder( thyroid abnormality, diabetes mellitus), severe cardiac disease,Inherited defects(sickle cell Anemia, Thalassemia, Aplastic anaemia), patient not willing to give blood sample.
结局指标
主要结局
Primary outcome is mainly assessed by comparing the pre, mid and post treatment heamoglobin level of the study 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 iron supply studies.(45 days)