A prospective open labelled , Non-randomized ,phase II clinical trial of Karisalai mathirai in the management of Pitha paandu (Iron deficiency Anaemia)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Relief of clinical symptoms mentioned in inclusion criteria
研究概览
简要总结
The study is a prospective open labelled ,non- randomized , phase II clinical study to evaluate the therapeutic efficacy of KARISALAI MATHIRAI in the management of Pitha Paandu(iron deficiency aneamia). The trial drug will be administered at the dose of 1-2 tablets BD A/F along with Butter milk for 45 days in 60 patients . The trial period of 12 months will be carrying out in Govt Siddha Medical College and Hospital, Palayamkottai , Tirunelveli ,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug KARISALAI MATHIRAI. The secondary outcome will be evaluation of Siddha diagnostic parameters , assessment of safety profile, pharmacological and biochemical parameters of trial drug.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Hb level between 7.
- •Pallor of skin , mucous membrane, conjuctiva, nailbeds
- •Fatigue, shortness of breath, palpitation
- •Anorexia 5.Blood loss due to menstrual disorders,hemorrhoids and peptic ulcer.
排除标准
- •Congenital heart disease
- •Patients with chronic renal disease
- •Liver disease 4.Inherited hemolytic defects 5.Thalassemia
- •Thyroid disease 7.Diabetes mellitus.
结局指标
主要结局
1. Relief of clinical symptoms mentioned in inclusion criteria
时间窗: 45 days
2. Increase in HB level
时间窗: 45 days
3. Improvement in lab parameters
时间窗: 45 days
次要结局
- 1. Evaluation of heamatinic activity of trial drug(2. Evaluation of additional effects and changes of siddha parameters in Pitha Paandu)