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The effect of topical nitroglycerin 0.2% on anal pain reduction

Comparing the effect of topical nitroglycerin 0.2% with placebo on pain severity reduction in patients with proctalgia fugax

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015122212789N12
Enrollment
40
Registered
2016-02-08
Start date
2014-05-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Proctalgia fugax. Anal spasm

Interventions

Intervention 1: Intervention Group: To use nitroglycerin 0.2% ointment as much as a cherry core 3 times a day (every 8 hours) on pain site and intra anal for 2 weeks. Intervention 2: Control Group: T
Treatment - Drugs
Intervention Group: To use nitroglycerin 0.2% ointment as much as a cherry core 3 times a day (every 8 hours) on pain site and intra anal for 2 weeks.
Control Group: To use the eucerin (placebo) as much as a cherry core 3 times a day (every 8 hours) on pain site and intra anal for 2 weeks.

Sponsors

Vice Chancellor for Research ,Kurdistan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria including: 1. Consent to participate in the study 2. Patients with recurrent episodes of severe pain localized in the lower rectum and anus area, and the episodes of pain lasting a few seconds up to 20 minutes and there was no pain between episodes. Exclusion criteria including: 1. Any proved pathology during clinical history, physical examination and rectosigmoidoscopy in anorectal including (Hemorrhoids, ischemia, anal abscess, anal fissure, rectocele, malignancy, inflammation, anal prolapsed). 2. History of trauma, urinary tract infection, surgery and hysterectomy in recent 6 months 3. Associated symptoms (fever, change in stool consistency, anemia, anal secretions, abdominal pain, weight loss and rectal bleeding). 4. History of heart and neurological disease and aortic stenosis 5. History of hypotension 6. Chronic proctalgia 7. Unwillingness to continue participating in the study 8. Single rectal ulcer

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain severity. Timepoint: The second week, three months and six months after treatment. Method of measurement: Visual Analog Scale.

Secondary

MeasureTime frame
The repetition of pain. Timepoint: The second week, three months and six months after treatment. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasomeh Allahmoradi

Kurdistan University of Medical Sciences

masuume1633@gmail.com+98 87 3323 1754

Outcome results

None listed

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