Health Condition 1: null- Haemorrhoids Health Condition 2: K649- Unspecified hemorrhoids
Conditions
Interventions
Intervention1: Comfort (P) Gel: extracts and oils of Cypress, Frankincense, Juniper Berry in a synergetic blend with white sesame.
Comfort (P) Gel should be applied locally in the anal area twice a da
Sponsors
GODS OWN STORE
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. Timepoint: At day 7±2, 15±2 and 30±2 following therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactDr Anit Singh MD
Clinical Research Network India
Outcome results
None listed