A multi-centric, randomised, comparative, clinical study for evaluation of herbal capsule in patients suffering from hemorrhoids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Assess the efficacy of herbal capsules (HILO) compared to Daflon in patients with Hemorrhoids.
研究概览
简要总结
Hemorrhoids are a very common anorectal condition affecting millions of people worldwide. Low compliance associated with non-pharmacological treatment along with adverse effects or complications associated with other therapeutic modalities renders use of herbal medicines as an important therapeutic option for management and treatment of hemorrhoids.
The present study is conducted to compare the efficacy and safety of herbal medicines Hilo and Daflon, the treatment of hemorrhoids.
Primary study objective is to assess the efficacy of herbal capsule (HILOTM) compared to Daflonin patients diagnosed with Hemorrhoids.
Secondary objectives : 1. Global assessment of efficacy by investigators and patients.
- To evaluate the safety of the investigational drug in Indian patients.
研究设计
- 研究类型
- Observational
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 of either gender, aged ≥18 years, with hemorrhoids confirmed by proctoscopy 2.Patients able to give signed informed consent before examination.
排除标准
- •1.Hypersensitivity to any of the ingredients of the formulation 2.Patients currently using other antihemorrhoidal drugs or planning to undergo any surgical procedure for hemorrhoids 3.Pregnant women, or lactating mothers 4.Patients otherwise judged to be inappropriate for inclusion in the study by the investigator.
结局指标
主要结局
Assess the efficacy of herbal capsules (HILO) compared to Daflon in patients with Hemorrhoids.
时间窗: Proportion of patients showing improvement in clinical symptoms
次要结局
- To evaluate the safety of the investigational product in Indian patients