Clinical Trial of Comfort (P) gel Efficacy and Safety in the Management of Haemorrhoids.

Phase 4

• Conditions: Health Condition 1: null- HaemorrhoidsHealth Condition 2: K649- Unspecified hemorrhoids

• Registration Number: CTRI/2018/04/013439
• Lead Sponsor: GODS OWN STORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either gender, aged >=18 years, with haemorrhoids (Grades 1, 2 or 3) confirmed by proctoscopy, visiting the OPD will be enrolled in the study.

2.Female subjects must have a negative pregnancy test. Pregnant patients will be excluded from the study.

3.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.

4.Participants must be willing to commit to medication dosing and assessment visits for evaluation.

5.Participants must be willing to refrain from taking any other medications for treatment of haemorrhoids, including pain-killer, laxatives or stool softener, from the outset of the study until final evaluation (if patient force to take above said medicine, subject will be dropped from the study).

6.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications without prior approval of the research team.

7.Participants must agree to take healthy diet and life style.

Exclusion Criteria

1.Patients with Grade 4/prolapsed haemorrhoids,

2. subjects who are pregnant or lactating mothers.

3.Patients currently using other anti-haemorrhoidal drugs or having taken any herbal medications in the last 30 days or planning to undergo any surgical procedure for haemorrhoids will be excluded from the study.

4.Patients with major hepatic, renal, or cardiovascular ailments will also be excluded from the study.

5.Participants with evidence or history of significant systemic, immunological, gastro-enteric or gastrointestinal disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).

6.Patients reporting use of laxative or stool softener during the study period.

7.Any participant who is not able to give adequate informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Number of patients achieving a composite score of 0 (indicative of the absence of all rectal symptoms and signs) at the end of day 30. <br/ ><br>2.Increase in total number of patients with a lower score, indicative of reduction in severity of the disease, for a given particular rectal symptom/sign at day 7±2, 15±2 and 30±2 following therapy. <br/ ><br>Timepoint: At day 7±2, 15±2 and 30±2 following therapy. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and/or severe adverse events observed throughout the study and spontaneously reported reactions after each application will be recorded during each visit.Timepoint: at day 7±2, 15±2 and 30±2 following therapy. <br/ ><br>