A Prospective,open labelled, Single arm, Non-randomized, Single centric, Phase II clinical trial to determine the effectiveness of Lavangapattai Kudineer in the management of Raththa Moolam( Bleeding Hemorrhoids)
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
- The outcome will be aimed at reducing the symptoms of Raththa Moolam(Bleeding Hemorrhoids) and to determine the therapeutic efficacy of clinical trail drug ( Lavangapattai Kudineer)
研究概览
简要总结
This is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF LAVANGAPATTAI KUDINEER IN THE MANAGEMENT OF RATHTHA MOOLAM( BLEEEDING HEMORRHOIDS ). After purification of the trial drug ,LAVANGAPATTAI KUDINEER is prepared and administered at the dosage of 110ml trice a day for 10 days, which is given to 40 Raththa moolam patients (20 OP and 20 IP Patients). The primary outcome will be to determine the therapeutic efficacy of LAVANGAPATTAI KUDINEER in the management of RATHTHA MOOLAM( BLEEDING HEMORRHOIDS). The secondary outcome is to collect various siddha literatures and modern journals, to evaluate Physiochemical, Phytochemical, Bio Chemical analysis, to evaluate safety profile for acute and sub-acute toxicity of trial drug LAVANGAPATTAI KUDINEER, to study anti-microbial activity for selected micro-organism to the LAVANGAPATTAI KUDINEER, to evaluate siddha parameter and compare the (including Envagai thervu) changes in RATHTHAMOOLAM during trial period, to evaluate modern parametric changes in Raththa Moolam patients, to evaluate the Bio statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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.Patients who will be having classical symptoms of bleeding piles (1st degree Internal Hemorrhoids) i.e. constipation, Bleeding per anus, Itching in the perianal region.
- •2.Patients who are all willing to give blood samples at subsequent visit are involved in this study.
排除标准
- •1.Patient having 2nd, 3rd degree internal haemorrhoids.
- •2.Pregnancy.
- •3.Fissure in ano.
- •4.Fistula in ano 5.Rectal Malignancy.
结局指标
主要结局
The outcome will be aimed at reducing the symptoms of Raththa Moolam(Bleeding Hemorrhoids) and to determine the therapeutic efficacy of clinical trail drug ( Lavangapattai Kudineer)
时间窗: The outcome will be aimed at reducing the symptoms of Raththa Moolam(Bleeding Hemorrhoids) and to determine the therapeutic efficacy of clinical trail drug ( Lavangapattai Kudineer)
次要结局
- 1. To collect various siddha literatures and modern journals.(2.To evaluate Physiochemical, Phytochemical, Bio Chemical analysis.)
研究者
R SATHIYASEELAN
Government Siddha Medical College and Hospital palayamkottai