No study to date has compared topical DTZ to MEBO ointment in the treatment of anal fissure. Therefore, the present study aims to compare the efficacy and safety of DTZ to MEBO in the treatment of acute anal fissure. The investigators propose to conduct a comparative randomized clinical study. In this study, the investigators will compare patients with acute anal fissure receiving MEBO ointment vs Topical DTZ ointment vs a combination of MEBO and DTZ ointment.
Hypothesis:
MEBO in combination with DTZ is more effective than DTZ or MEBO alone in the treatment of acute anal fissure.
Subjects must be 18 years and above.
Subjects with 3 months (90 days) or less history of painful anal fissure (AF), prior to screening, where AF-related pain-associated with, or following, defecation is experienced at least twice a week during the symptomatic phase, with pain scores at an average of ≥ 3 on an 11-point NRS (Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable).
Subjects with an average of ≥4 on an 11-point NRS during the screening phase for worst anal pain associated with, or following, defecation for the most recent 3 days on which the subject has defecated.
Subjects with evidence of a radial fissure, with induration at the edges, seen on anal examination.
Subjects unwilling to be examined for AF.
Lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region (hemorrhoidectomy, anal fistula surgery).
Incision of perianal abcess.
Subjects who have had sub-fissure injection of botulinum toxin within 6 months period prior to screening, or have used glyceryl trinitrate (GTN) ointment for >1 week in the 4 weeks prior to the screening visit.
Parallel
Diltiazem
DrugDTZ is a calcium channel blocker for the treatment of chronic anal fissure
Mebo
DrugMoist exposed burn ointment (MEBO) is a tropical Chinese medicine composed of sesame oil and herbal plants that is clinically used for the treatment of burn wound.
Change in Pain Score
Pain is evaluated through the Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable
Wound Healing
Wound healing is assessed through physical examination: digital rectal examination is not done in case of painful anal fissure. Assessment for wound healing will be performed by the treating physician of the patient. The patient will be asked to strain to make the anal fissure more visible. If it is difficult to see on physical examination, digital rectal exam is done carefully. The degree of healing will be reported as none, partial or complete.
Change in Pain Score
Pain is evaluated through the Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable
Wound Healing
Wound healing is assessed through physical examination: digital rectal examination is not done in case of painful anal fissure. Assessment for wound healing will be performed by the treating physician of the patient. The patient will be asked to strain to make the anal fissure more visible. If it is difficult to see on physical examination, digital rectal exam is done carefully.
Defecation Strain Score
Level of strain during defecation is graded on a four-point scale: serious strain was scored as 3, moderate strain as 2, mild strain as 1, and defecation without strain as 0
Global Impression of Improvement
The patient's global impression of improvement will be measured on a 7-point Likert scale where 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse.
Incidence of Treatment-Related Adverse Events
Incidence of Headache, Itching, Dizziness, Hypersensitivity reactions or Critical Change in Vital Signs.
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