A randomized prospective double blind, two arm, parallel assignment, placebo controlled study to evaluate the safety and efficacy of QlinÂ® in patients with first to third degree haemorrhoids

Dobra Dela doo0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Adult subjects who are able to give written informed consent.
•2. Male or female subjects, at least 18 years of age with a diagnosis of hemorrhoids (first, second or third degree).
•3. Except hemorrhoids (first, second or third degree), the subjects are judged to be in good general health, based on medical history, physical examination.
•4. 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.

•1. Pregnant and lactating women and women in post-partum period of up to 6 weeks.
•2. Subjects with a history of permanent anal prolapse and/or anal fistula
•3. Subjects with associated anal fissures and/or infective anal pathology.
•4. 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.
•5. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
•6. Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.

发起方

Dobra Dela doo