A prospective open labelled non-randomized phaseII clinical trial to evaluate the therapeutic efficacy of the Siddha medicine "Thiripalai Mathirai" (Internal) for the treatment 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
- 40
- 试验地点
- 1
- 主要终点
- Clinical and Therapeutic efficacy of the siddha medicine Thiripalai Mathirai in Pitha Paandu
研究概览
简要总结
The study is A Prospective Open Labelled Non Randomized Phase 2 Clinical trial to evaluate the therapeutic efficacy of THIRIPALAI MATHIRAI 1 with the adjuvant KARISALAI KUDINEER 100ml BD for 30 days in 40 patients during the trial period of 20 months that will be conducted in Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
The primary outcome will be the therapeutic efficacy of trial medicine Thiripalai Mathirai with the adjuvant Karisalai kudineer
The secondary outcome will be the evaluation of siddha diagnostic parameters Safety of trial drug and the adjuvant Pharmacological and Biochemical analysis of trial drug and the adjuvant
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
- •Patients with Hb level between 7 to 10 grams Pallor of skin mucous membrane conjunctiva nailbeds Fatigue Shortness of breath Palpitation Anorexia Worm infestations Blood loss due to Menstrual disorders Hemorrhoids Peptic ulcer Smear showing hypochromic microcytic RBCs.
排除标准
- •Patients with Congenital heart disease Chronic renal disease Liver disease Inherited haemolytic defects Thalessemia Thyroid disorder Diabetes mellitus.
结局指标
主要结局
Clinical and Therapeutic efficacy of the siddha medicine Thiripalai Mathirai in Pitha Paandu
时间窗: 30 days
次要结局
- Evaluation of siddha diagnostic parameters(Safety of trial drug and the adjuvant)