A randomized prospective double blind, two arm, parallel assignment, placebo controlled study to evaluate the safety and efficacy of Qlin® in patients with first to third degree haemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in the following symptoms Pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 30
研究概览
简要总结
This study is designed to be a randomized prospective double blind, two arm, parallel assignment, placebo controlled study to evaluate the efficacy and safety of Qlin® in patients with First, Second or Third degree haemorrhoids. A double blind parallel group randomized placebo controlled study design was chosen as an appropriate study design to achieve unbiased treatment in this clinical trial. This clinical study was planned to be conducted over a period of up to 60 days, of which 30 days before visit 1 was considered to be “Screening Period†and the treatment period starts from Day 1, which visit 1. Visit 1 is followed by three consecutive visits scheduled ay Day 10 (Visit 2), Day 20 (Visit 3) and Day 30 (Visit 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects who are able to give written informed consent.
- •Male or female subjects, at least 18 years of age with a diagnosis of hemorrhoids (first, second or third degree).
- •Except hemorrhoids (first, second or third degree), the subjects are judged to be in good general health, based on medical history, physical examination.
- •If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable since last 3 months prior to baseline and throughout the study.
排除标准
- •Pregnant and lactating women and women in post-partum period of up to 6 weeks.
- •Subjects with a history of permanent anal prolapse and/or anal fistula
- •Subjects with associated anal fissures and/or infective anal pathology.
- •Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photocoagulation, cryotherapy etc) within 2 year of enrolment into the trial.
- •Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
结局指标
主要结局
Change in the following symptoms Pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 30
时间窗: Day 1, Day 10, Day 20 and Day 30
Change in the following objective signs
时间窗: Day 1, Day 10, Day 20 and Day 30
Congestion, oedema, and exudation as assessed by the investigator
时间窗: Day 1, Day 10, Day 20 and Day 30
Change in overall assessment of disease condition as assessed by the subject on a 10 cm Visual Analogue Scale
时间窗: Day 1, Day 10, Day 20 and Day 30
次要结局
- Physical Examination(Vital Signs: Pulse rate, blood pressure and body temperature)