A Prospective Open labelled non randomized phase II clinical trial on MUSUMUSKKAI KUDINEER 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
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the therapeutic efficacy of clinical trial drug in management of Pitha Paandu
研究概览
简要总结
The study is a Prospective Open Labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of MUSUMUSKKAI KUDINEER in the management of PITHA PAANDU (IRON DEFICIENCY ANAEMIA) .The trial drug will be administrated at the dose of 30-60 ml twice a day (orally) A/F 45 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be evaluation of therapeutic efficacy of trial drug MUSUMUSKKAI KUDINEER. The secondary outcome will be the evaluations of siddha diagnostic parameters, assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility.
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 59.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Hb level above 7.0 grams.
- •below 10 grams 2.Patient with the symptoms of Pallor of skin, Mucous membrane, Conjunctiva, Nail beds. Fatigue, shortness of breath, palpitation. Worm infestations. Blood loss due to Menstrual disorders, Hemorrhoids, and Peptic ulcer 3.Clinically diagnosis in Iron Deficiency Anaemia, smear showing hypochromic microcytic anaemia.
排除标准
- •1.Hb levels below 7.0 grams and above 10 grams 2.Congenital heart diseases 3.Patients with chronic renal diseases 4.Liver diseases 5.Inherited hemolytic defects 6.Thalassemia 7.Thyroid disorder 8.Diabetes mellitus 9.Pregnancy and lactating mother.
结局指标
主要结局
To evaluate the therapeutic efficacy of clinical trial drug in management of Pitha Paandu
时间窗: 45 days
次要结局
- 1.To evaluate the biochemical physico-chemical and phytochemical analysis of clinical trial drug(2.To evaluate the antimicrobial activity of trial drug)