Clinical evaluation of the efficacy of punnarnavashtak kwath in the management of pandu rog w.s.r. to iron deficiency anaemia - a randomized controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement Hb%
研究概览
简要总结
This is a randomized , single blind , parallel group , controlled trial to evaluate punarnavashtak Kwath is more efficative than Vasadi Kwath in the management of Pandu Rog w.s.r. to Iron Deficiency Anemia for 12 months in 60 patients will be conducted in India . The primary outcome measures improvement in Hemoglobin percentage and serum Ferritin level . The secondary outcome measures improvement in subjective parameters such as Panduta , Daurbalya , Aruchi , Aalasya , Shwas , Hridyaspandan , Gatrashoola .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Patients presenting with classical signs and symptoms of Pandu Rog i.e. Panduta, Daurbalya, Aruchi, Aalaysa, Shwas , Hridyaspandan and Gatrashool will be selected . Minimum 4 symptoms from above will be included . 2) Age with age group 18 – 60 yrs. 3) Haemoglobin level.
- •below 12 gm/dl in Female and below 13 gm/dl in Male 4) Serum Ferritin.
- •below 30 ng/ml in Female and below 50 ng/ml in Male 5) Patients will be selected irrespective of Gender , Occupation and Socioeconomic status .
排除标准
- •Age less than 18 yrs and more than 60 yrs.
- •Haemoglobin level below 5 gm/dl 3) Pregnant and lactating mother 4) Any Bleeding Disorders e.g. Haematemesis , Bleeding Piles etc.
- •Anaemia other than Iron Deficiency Anaemia .
- •Severe Renal / Hepatic / Cardiac disease 7) Those Patients not willing for trial and not giving written consent .
结局指标
主要结局
Improvement Hb%
时间窗: 2 months
1. Marked Increased greater than or equal to 1.5 gm/dl
时间窗: 2 months
2. Moderate Increased by 1 to 1.4 gm/dl
时间窗: 2 months
3. Mild Increased by 0.5 to 0.9 gm/dl
时间窗: 2 months
4. Poor Increased by 0 to 0.4 gm/dl
时间窗: 2 months
Improvement Serum Ferritin
时间窗: 2 months
1. Marked Increase greater than 3 ng/dl
时间窗: 2 months
2. Moderate Increase by 2.1 to 3 ng/dl
时间窗: 2 months
3. Mild Increase by 1.1 to 2 ng/dl
时间窗: 2 months
4. Poor Increase by 0 to 1 ng/dl
时间窗: 2 months
次要结局
- Improvement in subjective parameters such as(1) Panduta ( Pallor ) 2) Daurabalya ( Weakness ) 3) Aruchi ( Anorexia ) 4) Aalaysa ( Inactivity) 5) Shwas (Dyspnoea) 6) Hrudyaspandan (Palpitation) 7) Gatrashula ( Bodyache))
研究者
Aniket Purushottam Raut
Radhakisan Toshniwal Ayurved Mahavidyalaya, Akola