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IRCT20210110049992N1 IRCT 2025-02-18 barijessence company Anti-fissure cream and diltiazem gel on anal fissure Comparison of The efficacy of Anti-fissure barij cream and diltiazem gel in severity of pain, bleeding and healing of anal fissure 2025-03-09 anticipated 80 Complete https://irct.ir/trial/81798 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block Unit of randomization: Individual Randomization tool: Python software with the randint function, random sequence in blocks of four individuals, considering A as Antifischer cream and B as Diltiazem gel, with sequences such as AABB, BBAA, BABA, ABAB, BAAB, ABBA. Both Antifischer cream and Diltiazem gel are colorless and odorless. Both will be packaged in unmarked, brand-free tubes, Blinding description: Both the Antifischer cream and the Diltiazem gel are colorless and odorless. They will both be contained in tubes that lack any markings or brand identifiers. Clinical evaluators will receive these tubes and administer them to patients according to specified guidelines, while only the researchers are aware of the type of these tubes. Patients are also unaware whether they are receiving Diltiazem gel or Antifischer cream. 1-2 Anal fissure. Intervention 1: Intervention Group A: Receives Barriage Essence company's Antifischer cream, applied twice daily using an applicator at the anal site. The cream will be provided in 50-gram tubes, uniform in color and size, and filled in the formulation section of Barriage Essence pharmaceutical company. Intervention 2: Intervention Group B: Receives 2% Diltiazem gel from Sobhan Darou company. Applied twice daily using an applicator at the anal site. The gel will be provided in 50-gram tubes, uniform in color and size, and filled in the formulation section of Barriage Essence pharmaceutical company. Yes - There is a plan to make this available What will be shared: All information related to the participants will be accessible alongside the study protocol. When: The access period will begin 6 months after the publication of the results. To whom: Academic Researchers Conditions: Only academic researchers will have access by submitting a request to the corresponding author. Where to obtain: By sending an email to the corresponding author of the paper. How to obtain: Emails sent to the corresponding author will be reviewed within 3 weeks, and responses will be sent to the individual via email. Comments:
public Abdolhosein Davoodabadi
Pezeshk Blvd. - Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5547 2939 Davoodabadi-A@kaums.ac.ir Kashan University of Medical Sciences scientific Abdolhosein Davoodabadi
Pezeshk Blvd. - Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5547 2939 Davoodabadi-A@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with acute fissure Age more than 15 years old 15 years no limit Both Hemorrhoid Anal fistula Anal abcess Pregnancy Breastfeeding Malignancy K60.2 Anal fissure, unspecified Treatment - Drugs Treatment - Drugs Intervention Group A: Receives Barriage Essence company's Antifischer cream, applied twice daily using an applicator at the anal site. The cream will be provided in 50-gram tubes, uniform in color and size, and filled in the formulation section of Barriage Essence pharmaceutical company. Intervention Group B: Receives 2% Diltiazem gel from Sobhan Darou company. Applied twice daily using an applicator at the anal site. The gel will be provided in 50-gram tubes, uniform in color and size, and filled in the formulation section of Barriage Essence pharmaceutical company. Anal fissure grade after treatment. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after treatment. Method of measurement: Clinical examination by a physician and decisions based on the following grades:Grade 0: HealedGrade 1: Fissure with visible internal anal sphincterGrade 2: Deeper fissures with more extensive visibility of the internal anal sphincterGrade 3: Fissure with indeterminate depthGrade 4: Accompanied by perianal fistula. Hemorrhage grade. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment initiation. Method of measurement: Asking the patient: Score 0: No bleedingScore I (mild): Presence of blood streaks in stoolScore II (moderate): Intermittent bleeding during defecationScore III (severe): Continuous bleeding during defecation. Pain severity during defication. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment initiation. Method of measurement: Pain Severity: Numeric Rating Scale (NRS-11) - This is a patient-reported scale used for adults and children aged 10 years or older. It is defined as follows:Score 0: No painScore 1-3: Mild pain (annoying but causes little interference with daily activities)Score 4-6: Moderate pain (significantly interferes with daily activities)Score 7-10: Severe pain (disabling and unable to perform daily activities). barijessence company Approved 2022-02-09 Ethics committee of Kashan University of Medical Sciences Pezeshk Blvd. - Qotb Blvd. Kashan Isfehan Iran (Islamic Republic of)