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estimation of the efficacy and adverse effect of daflon when it is added to the conventional treatments in patients with acute hemorrhoids

The Efficacy of Adding Daflon to the Conventional Treatment on the Improvement of Symptoms and Health-Related Quality of Life in the Patients with Acute Hemorrhoids: A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141201020178N9
Enrollment
50
Registered
2019-05-24
Start date
2018-03-16
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hemorrhoidal disease. Hemorrhoids and perianal venous thrombosis

Interventions

Intervention 1: Control group: topical anti-Hemorrhoid ointment, Sitz bath and lifestyle modifications. Intervention 2: Intervention group
Daflon 1500 mg twice in a day orally in the first four days and 1000 mg twice in a day for three days later, added to the conventional treatment.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age more than 18 years acute hemorrhoid crisis(anal pain and anal bleeding)

Exclusion criteria

Exclusion criteria: Grade I and IV of hemorrhoid previous history of surgery related to the anorectal or hemorrhoid disease lactation Patients with the history of other chronic systemic diseases, such as heart, kidney, or liver disease, hypertension, seizure pregnancy cancer history medications such as anti-depressant and flavonoid drugs non-cooperative sleep disorders allergy to daflon

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: Before and two weeks after starting treatment. Method of measurement: VAS.;Bleeding. Timepoint: Before and two weeks after starting treatment. Method of measurement: No bleeding / with every defication / daily / weekly / monthly.;SF-12V1 Health Survey Questionnaire. Timepoint: before and 2 weeks after the starting the treatment. Method of measurement: SF-12V1 questionnaire.

Secondary

MeasureTime frame
Patient compliance rate. Timepoint: two weeks after starting treatment. Method of measurement: Data gathering sheet.;Adverse effect rate. Timepoint: 2 weeks after the beginning of the treatment. Method of measurement: patients data gathering sheets.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Mokhtare

Iran University of Medical Sciences

mokhtare.m@iums.ac.ir+98 21 6655 4790

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026