Role of QlinÂ® (Natural cream spray) for external use in treating the patients with first to third degree haemorrhoids

Active, not recruiting

Brief Summary: 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 QlinÂ® 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 â€œScreening Periodâ€ 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).

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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 3.
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.

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	Day 1, Day 10, Day 20 and Day 30
Change in the following objective signs	Day 1, Day 10, Day 20 and Day 30
Congestion, oedema, and exudation as assessed by the investigator	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	Day 1, Day 10, Day 20 and Day 30

Secondary Outcome Measures

Name	Time	Method
Physical Examination	Vital Signs: Pulse rate, blood pressure and body temperature

Locations (1): Sapthagiri Institute of Medical Sciences and Research Center
🇮🇳
Bangalore, KARNATAKA, India
Sapthagiri Institute of Medical Sciences and Research Center
🇮🇳Bangalore, KARNATAKA, India
Dr Manjunath BG
Principal investigator
9731799114
dr.bgmanjunath@gmail.com