A Clinical evaluation for the effectiveness of Thiripalathy Legium with adjuvant Ayakantha Chenduram in the treatment of Paandu Noi (Iron Deficiency Anaemia) among out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.
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
- Assessment of Haemoglobin level, Red Blood Cell Indices and Peripheral Blood Smear
研究概览
简要总结
BACKGROUND
Siddha medicine is one of the holistic healing system of medicine in southern India. According to derangement of three humours (Vali, Azhal & Aiyam) diseases are classified as 4448 in number. Paandu Noi is one among them and been classified into 5 types in Yugi Vaidhya Chinthamani.
According to WHO, Anaemia is defined as a condition with haemoglobin level less than 7.7 mmol/l (13g/dl) in men and 7.4 mmol/l (12g/dl) in women which has a wide variety of causes. Iron deficiency is considered to be the most common cause of anaemia.
PRIMARY OBJECTIVE
To evaluate the effectiveness of Siddha formulation Thiripalathy Legium with adjuvant Ayakantha Chenduram in the treatment of Paandu Noi (Iron Deficiency Anaemia) through haematological investigation of Haemoglobin in Hb gm%, Red Blood Cell Indices and Peripheral Blood Smear before and after treatment.
SECONDARY OBJECTIVE
Assessment of improvement through other clinical laboratory blood parameters including Serum Ferritin level and Total Iron Binding Capacity (TIBC).
TREATMENT PLAN
Day 1: Arakku Thailam is advised for oil Bath.
Day 2: Agasthiyar Kuzhambu a gentle laxative is advised.
Day 3: Patient is advised to take rest.
Day 4: Thiriphalathy legium will be given as interventional medicine for 90 days.
INTERVENTIONAL DRUG
Internal medicine : THIRIPALATHY LEGIUM
Dosage : Arai Thola (6g), Twice a day
Adjuvant : Aya kantha Chenduram, 65mg
Duration : Orumandalam (90 days)
PRIMARY OUTCOME
Assessment of Haemoglobin level, Red Blood Cell Indices and Peripheral Blood Smear from the baseline and increase in these haematological parameters will be considered as improvement.
SECONDARY OUTCOME
The clinical lab parameters including Serum ferritin and Total iron binding capacity will be assessed.
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 ranging from seven to nine point nine gram per deciliter According to WHO criteria normal range for adult men is greater than or equal to thirteen gram per deciliter and for adult women is greater than or equal to twelve gram per deciliter 2.Patient willing to undergo blood investigation.
排除标准
- •1.Patient with Renal diseases 2.Patient with Diabetes Mellitus 3.Patient with any malignancy 4.Patient with Tuberculosis 5.Patient with Inherited Blood Disorders 6.Patient with occult blood positive 7.Lactating and pregnant women.
结局指标
主要结局
Assessment of Haemoglobin level, Red Blood Cell Indices and Peripheral Blood Smear
时间窗: 90 days
from the baseline and increase in these haematological parameters will be considered as improvement.
时间窗: 90 days
次要结局
- The clinical lab parameters including Serum ferritin and Total iron binding capacity will be assessed.(90 days)