Clinical evaluation of siddha drug Vallarai Nei in the treatment of Pitha Pandu (Iron Deficiency anemia)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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 Haemoglobin 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 VALLARAI NEI(Prepared from 20 herbal constituents and cow ghee and rock sugar) in patients with Pitha pandu (IRON DEFICIENCY ANAEMIA).In this trial 40 patients will be recruited and before starting the treatment ,purgation will be given with OP medicine Meganatha kuligai 2 pills with ginger juice at early morning at empty stomach for one day.Then the trial drug VALLARAI NEI will be administrated 4ml twice a day after food for a period of 48 days.During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in OPD /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
- 13.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Hemoglobin level less than normal range For male 7 to 12gms/dl For female 7 to 11gms/dl 2)Patient blood smear shows Microcytic Hypochromic RBC 3)Patient willing to undergo blood investigation 4)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
- •Parasitic infection 2)Pregnancy and lactation 3)History of bronchial asthma 4)History of sinusitis 5)Presence of any severe illness(CA,RA) 6)Endocrine disorder( thyroid abnormality diabetes mellitus) 7)History of cardiac disease 8)History of renal disease 9)Inherited defects like sickle cell anemia thalassemia aplastic anemia 10)Patient not willing to give blood sample 11)Epilepsy.
结局指标
主要结局
Primary outcome is mainly assessed by comparing the pre and post treatment Haemoglobin level of the trial patient
时间窗: Prestudy screening and after treatment
次要结局
- It is assessed by comparing following parameters before and after treatment(1)Reduction of clinical symptoms)