An Open-label, Single-arm Clinical Study to Evaluate the Efficacy and Safety of Arshtab-h70 in the Management of Primary Hemorrhoids
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Bleeding per rectum, Size of pile mass.
研究概览
简要总结
This is a single-Arm, prospective study involving patients with primary hemorrhoids. Adult male and female participants, aged 18 to 75 years, diagnosed with primary hemorrhoids, will be selected for the study. Eligible participants, based on inclusion and exclusion criteria, will provide written informed consent during the screening visit. during which laboratory reports will be reviewed to confirm eligibility. Following this assessment, patients who meet all criteria will be randomly assigned to study group consisting of patients with primary hemorrhoids without secondary complications, the patient physical examination, DRE, and basic blood investigation like CBC and RBS will be performed.
The safety of the treatment will be assessed by monitoring adverse events, conducting routine hematological and biochemical tests, performing physical exams, and recording vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Symptomatic primary hemorrhoids, Grades I-II by direct anoscopic visualization (anoscopic visualization not required if Grade determined by colonoscopy within 21 days prior to Day 1).
- •2 Bleeding from hemorrhoids for two consecutive days prior to randomization (Day 1).
- •3 The patient having Bleeding hemorrhoids, Pain in anal region due to piles complication (i.e. Inflammation, thrombosis), prolaps, itching, constipation two days prior to randomization (Day 1) will be selected for this clinical study.
- •4 For female patients cause of bleeding due to menses should be ruled out.
- •5 Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily) 6 Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- •7 Capable of and freely willing to provide written informed consent prior to participating in the study.
- •8 Signed informed consent prior to any study-mandated procedure.
- •9 Willing to comply with daily protocol.
排除标准
- 未提供
结局指标
主要结局
Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Bleeding per rectum, Size of pile mass.
时间窗: Follow-up visits will be scheduled on the 7th, 15th, and 21st days after enrollment. A window period of ± 2 days will be allowed for each follow-up visit.
次要结局
- Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Protrusion of mass, Constipation, Tenderness, Pain.(Follow up visits will be scheduled at 7th, 15th, & 21st days after enrollment. A window period of ± 2 days will be allowed for each follow up visit.)
研究者
Dr Amit A Paliwal
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune