Internal hemorrhoids. Other hemorrhoids
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age between 18 to 75 years Diagnosed with acute uncomplicated grade I or II internal hemorrhoids Presence of hemorrhoidal symptoms at the time of enrollment Willingness to participate and providing informed consent
Exclusion criteria
Exclusion criteria: History of contact allergic reactions to herbal medicines Presence of severe anorectal pain at baseline Pregnancy or breastfeeding Previous history of anorectal surgery Presence of liver cirrhosis Presence of malignancy Coexisting anorectal diseases (inflammatory bowel disease, anal fissure, proctitis, perianal abscess, perianal hematoma, rectal prolapse, rectal varices) Presence of bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of anal pain. Timepoint: Before the intervention and 3, 10 and 30 days after starting to use suppositories. Method of measurement: Visual analogue scale (VAS) (0 to 10) by patient.;Bleeding severity. Timepoint: Before the intervention and 3, 10 and 30 days after starting to use suppositories. Method of measurement: Based on physician assessment using Proctologic Numeric Rating scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction with treatment. Timepoint: On day 10 and 30 days after starting suppository use. Method of measurement: Five-choice questionnaire (scale 1 to 5).;Quality of life. Timepoint: Before the intervention and 10 and 30 days after starting suppository use. Method of measurement: The 5-level version of the EuroQol 5-Dimension instrument (five domains, with Likert scoring).;Number of hemorrhoidal columns involved. Timepoint: Before the intervention and 10 days after starting suppository use. Method of measurement: Based on physician assessment using Proctologic Numeric Rating scale.;Prolapse. Timepoint: Before the intervention and 10 days after starting suppository use. Method of measurement: Proctologic Numeric Rating scale.;Discomfort during defecation. Timepoint: Before the intervention and 3, 10 and 30 days after starting suppository use. Method of measurement: Visual Analogue Scale (VAS) (0 to 10) by the patient.;Severity of anal itching. Timepoint: Before the intervention and 3, 10 and 30 days after starting suppository use. Method of measurement: Visual Analogue Scale (VAS) (0 to 10) by the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Shahid Beheshti University of Medical Sciences