A Phase 4 interventional study of Nifedipine 20 Mg and Placebo in Hemorrhoids, Postoperative Pain and Wound Healing, sponsored by Sana'a University. Not yet recruiting at 1 site in Yemen. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Sana'a University · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to evaluate whether oral nifedipine reduces postoperative pain and improves wound healing after hemorrhoidectomy in adult patients aged 18-65 years undergoing elective surgery for grade III or IV hemorrhoids in Sana'a, Yemen.
The main questions it aims to answer are:
Researchers will compare the nifedipine group to the placebo group to see if there is a significant reduction in pain scores, faster wound healing, lower analgesic consumption, and fewer complications.
Participants will:
Hemorrhoidal disease affects approximately 4.4% of the global population and is one of the most common anorectal conditions. Post-hemorrhoidectomy pain remains the most significant complaint and barrier to recovery, often exceeding patient expectations and delaying return to daily activities. The pathophysiology involves tissue trauma, inflammation, and internal anal sphincter spasm, which creates a cycle of pain and impaired healing. Calcium channel blockers such as nifedipine reduce smooth muscle tone and improve local microcirculation, suggesting benefit in this context. While topical calcium channel blockers have been studied, oral nifedipine offers advantages in compliance, predictable systemic delivery, and suitability for resource-limited settings such as Yemen. This trial addresses a specific gap in evidence for oral nifedipine after hemorrhoidectomy.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral nifedipine 20 mg capsule twice daily (every 12 hours) for 14 consecutive days. First dose administered 6 hours after surgery.
Drug: Nifedipine 20 Mg
Identical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery.
Drug: Placebo
Nifedipine 20 mg immediate-release oral capsule, twice daily for 14 days. First dose 6 hours after surgery. L-type calcium channel blocker causing internal anal sphincter smooth-muscle relaxation, reduced resting pressure, improved local blood flow, and potential anti-inflammatory/analgesic effects.
Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.
Visual Analogue Scale (VAS) Pain Score
Pain intensity measured on a 0-10 Visual Analogue Scale. Higher scores indicate worse pain. Assessed at rest and with defecation.
Time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing.
Time frame: Day 7, Day 14, Day 28
Time to Complete Wound Healing
Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination.
Time frame: Up to Day 28 (censored if not healed by Day 28)
Rescue Analgesic Consumption
Total number of paracetamol and diclofenac doses consumed during the 14-day study period.
Time frame: Day 0 through Day 14
Postoperative Complications
Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.
Time frame: Day 7, Day 14, Day 28
Return to Normal Daily Activities
Number of days until patient reports return to normal daily activities (self-reported).
Time frame: Day 28
Return to Work
Number of days until return to employment or usual occupational duties (self-reported).
Time frame: Day 28
Patient Satisfaction
Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied.
Time frame: Day 28
Adverse Events - Cardiovascular
Incidence of hypotension (systolic blood pressure \[SBP\] \< 90 mmHg), dizziness, flushing, headache, tachycardia.
Time frame: Throughout 14-day treatment and Day 28
Adverse Events - General
Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms.
Time frame: Throughout 14-day treatment and Day 28
Plan to share: No — The study team does not plan to share individual participant data with other researchers. This is a single-center thesis study with limited data management infrastructure, and the dataset contains identifiable clinical information that cannot be sufficiently de-identified for broad sharing under local ethical guidelines.
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nifedipine
Sana'a University