Health Condition 1: null- hemorrhoids (first, second or third degree
Conditions
Interventions
Intervention1: Qlin natural: Qlin® product consist of following natural plant extracts Alantoin, Quercus alba bark extract, Hamamelis virginiana bark/leaf extract, and Aesculu hipocastanum seed extra
Sponsors
Dobra Dela doo
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the following symptoms Pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 30 Change in the following objective signs Congestion, oedema, and exudation as assessed by the investigator Change in overall assessment of disease condition as assessed by the subject on a 10 cm Visual Analogue Scale Timepoint: Day 1, Day 10, Day 20 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination Vital Signs: Pulse rate, blood pressure and body temperature Urine Pregnancy Test Adverse Event Assessments Timepoint: Day 1, Day 10, Day 20 and Day 30. | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
Bio Agile Therapeutics Pvt. Ltd.
Outcome results
None listed