Hemorrhoids Grade I and II
Conditions
Brief summary
Post market, single arm, clinical investigation to assess safety and performance of the product.
Interventions
DEVICEHemoclin Gel
Non sterile gel for intra-rectal use
Sponsors
Karo Pharma AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects. 2. Sex: male or female. 3. Age: more than 18 years old. 4. Symptomatic haemorrhoids stage 1 and 2 (Goligher classification). 5. Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study. 6. Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day). 7. Able and willing to provide informed consent and comply with study procedures
Exclusion criteria
1. Pregnant or nursing woman or planning a pregnancy during the study. 2. Subject not able or not willing to provide informed consent and comply with study procedures 3. Subject who had been deprived of their freedom by administrative or legal decision. 4. Major subject who is under guardianship or who is not able to express his consent. 5. Subject in a social or sanitary establishment. 6. Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology 7. Grade III or IV haemorrhoids (Goligher classification). 8. Other pre-existing anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections. 9. Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment 10. Any anal topical medication applied in last 7 days. 11. Known or suspected sensitivity or allergy to ingredients of the investigational product. In terms of COVID pandemic 12. Subject who was abroad in a country with higher incidence rate of Covid-19 than Poland within 14 days before the beginning of the study. 13. Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°C. 14. Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study. 15. Subject who is currently during home quarantine recommended by the Sanitary Inspection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II. | 2 weeks | Severity of itch will be evaluated by the patient with a 6 point structured scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate by the patient the efficacy of tested product on the severity of bleeding | 2 weeks | Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant. |
| To evaluate by the patient the efficacy of tested product on the sense of discomfort | 2 weeks | Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant. |
| To evaluate the overall satisfaction of the patient according to | 2 weeks | Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant. |
| To evaluate the instant cooling effect, less painful toilet visit each day using a daily log, | 2 weeks | Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant. |
Countries
Poland
Outcome results
None listed