Clinical evaluation of siddha herbal formulation Aswathy Chooranam in the treatment of Pitha Paandu (Iron Deficiency Anaemia)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy of Aswathy chooranam through the change in the Haemoglobin
研究概览
简要总结
BACKGROUND: Anaemia refers to the state in which the level of haemoglobin in blood is below the normal range appropriate for the age and sex . Iron is an essential mineral needed to form haemoglobin , an oxygen carrying protein inside red blood cells .Iron deficiency anaemia is characterised by deficiency of haemoglobin in RBC ( low MCH and MCHC ) with low colour index and in many cases the RBC’s are smaller than normal.According to Siddha there are 7 important constituents namely saaram , seneer , oon ,kozhupu , enbu , majjai , sukkilam / suronitham also known as sapthathaathu in which anemia occurs due to the deficiency of the rakthadhatu in the body. According to Yugi Vaithiyasinthamani 800, the symptoms of Pitha paandu coorelates with symptoms of iron deficiency anaemia. This is an open clinical trial that evaluates the effectiveness of Siddha formulation Aswathy chooranam in the treatment of Pitha Paandu (Iron Deficiency Anaemia).
OBJECTIVE:
PRIMARY OBJECTIVE : Evaluation of Siddha formulation Aswathy chooranam in the treatment of Pitha Paandu (Iron Deficiency Anaemia) through improvement in Haemoglobin level of the study patients before and after the treatment.
SECONDARY OBJECTIVE : 1.To evaluate the clinical lab parameters including CBC as per outcome before and after treatment
2.To study the cofactors related to the disease (i.e., age, sex, socio economic status, family history, occupation, habits) etc., and to study the siddha basic principles like Envagaithervu, neerkuri and Neikuri, Udalthathukal, Uyirthathukal, Kaalam, Nilam(Thinai) etc., in PithaPaandu patients.
3.Smear study and Serum ferritin levels, TIBC before and after treatment
METHODOLOGY: A total of 30 diagnosed patients of Pitha Paandu (Iron Deficiency Anaemia) within the age limit of 18 to 60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Known case of Malignancy, Chronic Kidney Disease, Severe Cardiac Disease (or) IHD, Severe systemic illness, Tuberculosis, Inherited blood disorders ( Sickle cell anaemia, Thalassemia), Patients not willing to give blood sample, Pregnant / Lactating mother will be excluded.
OUTCOME:
PRIMARY OUTCOME: Evaluation of the efficacy of Aswathy chooranam through the change in the Haemoglobin level of the study patients before and after treatment
SECONDARY OUTCOME: 1.Reduction of clinical symptoms before and after treatment
- Assessment of the clinical laboratory parameters like Total RBC, PCV, MCV, MCH, MCHC before and after treatment
3.Smear study and Serum ferritin levels, TIBC before and after treatment
RESULTS AND DISCUSSION : The result will be statistically analysed
KEYWORDS: Aswathy chooranam, Pitha Paandu, Iron Deficiency Anaemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Hb level less than normal range, (According to WHO criteria) For male: 9-11gms/d1 ( normal: 13 gms/d1] For female: 8-10gms /dl (normal: 12 gms/d1] 2.Patient willing to undergo blood investigation.
- •3.Patients who are willing to participate in study and signing in informed consent form.
排除标准
- •1.K/C/O Malignancy 2.K/C/O Chronic Kidney Disease 3.K/C/O Severe Cardiac Disease (or) IHD .
- •4.Severe systemic illness 5.K/H/O Tuberculosis 6.Patients not willing to give blood sample.
- •7.Pregnant / Lactating mother 8.K/C/O Inherited blood disorders ( Sickle cell anaemia, Thalassemia.
结局指标
主要结局
Evaluation of the efficacy of Aswathy chooranam through the change in the Haemoglobin
时间窗: 18 MONTHS
level of the study patients before & after treatment
时间窗: 18 MONTHS
次要结局
- 1.Reduction of clinical symptoms before & after treatment(2.Assessment of the clinical laboratory parameters like Total RBC, PCV, MCV, MCH, MCHC)