A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KUPPAIMENI CHOORANAM 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
- Of during and after treatment and reduction in clinical symptoms of bleeding during defecation, constipation after defecation, pruritus ani.
研究概览
简要总结
The study is a prospective open labelled phase II non-randomized clinical trial to evaluate the therapeutic efficacy of KUPPAIMENI CHOORANAM in the management of RATHA MOOLAM (BLEEDING HAEMORRHOIDS). The trial drug will be administered orally at the dose of 1gm twice a day A/F for 45 days along with water as adjuvant in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug KUPPAIMENI CHOORANAM. The secondary outcome will be the evaluation 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 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.Patients of age below 18 years and above 60 years.
- •2.Patient having 2nd, 3rd degree internal haemorrhoids,Pregnancy,Fissure in ano,Fistula in ano,Diabetes mellitus,Systemic Hypertension.
- •Rectal Malignancy.
结局指标
主要结局
Of during and after treatment and reduction in clinical symptoms of bleeding during defecation, constipation after defecation, pruritus ani.
时间窗: 45 days
次要结局
- 1.To evaluate the pharmacological activities of(trial drug.)