Role of Qlin® (Natural cream spray) for external use in treating the patients with first to third degree haemorrhoids
- Conditions
- Health Condition 1: null- hemorrhoids (first, second or third degree
- Registration Number
- CTRI/2017/03/008019
- Lead Sponsor
- Dobra Dela doo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the following symptoms Pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 30 <br/ ><br>Change in the following objective signs <br/ ><br>Congestion, oedema, and exudation as assessed by the investigator <br/ ><br>Change in overall assessment of disease condition as assessed by the subject on a 10 cm Visual Analogue Scale <br/ ><br>Timepoint: Day 1, Day 10, Day 20 and Day 30
- Secondary Outcome Measures
Name Time Method Physical Examination <br/ ><br>Vital Signs: Pulse rate, blood pressure and body temperature <br/ ><br>Urine Pregnancy Test <br/ ><br>Adverse Event Assessments <br/ ><br>Timepoint: Day 1, Day 10, Day 20 and Day 30.