Effect of new combination gel in the treatment of acute anal fissures

Comparison of the effectiveness of combination gel (diltigel2%-ureacolchicine) with diltigel 2% in the treatment of acute anal fissures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221203056698N1

Enrollment

Registered

2023-10-11

Start date

2023-12-10

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Condition 1: Acute anal fissures. Condition 2: Acute anal fissures. Anal fissure, unspecified Anal fissure, unspecified

Interventions

Intervention 1: Intervention group: For the patients of this group, 2% Diltigel gel will be administered externally once every twelve hours. Intervention 2: Intervention group: For the patients of the

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age over 18 years Consent to participate in the study Suffering from acute anal fissure as diagnosed by a specialist doctor

Exclusion criteria

Exclusion criteria: Having IBD Receiving chemotherapy drugs Being under radiotherapy History of Fisher and hemorrhoid surgery Receiving medicine and herbal gel for the treatment of fissure Receiving Diltigel before entering the study Receiving lidocaine and tetracycline before entering the study Having gout History of uncontrolled blood pressure Allergy to the drugs used in this study

Design outcomes

Primary

Measure	Time frame
The amount of pain in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of pain will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin. The intensity of pain will be checked with the help of visual pain scale (VAS).;The amount of itching in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of itching will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin.and all the datas will be collected by the same person.;The amount of bleeding in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of bleeding will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duratio	—

Measure

Time frame

The amount of pain in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of pain will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin. The intensity of pain will be checked with the help of visual pain scale (VAS).;The amount of itching in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of itching will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin.and all the datas will be collected by the same person.;The amount of bleeding in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of bleeding will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duratio

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Azhugh

Tabriz University of Medical Sciences

danesh@tbzmed.ac.ir+98 41 3335 6047

Outcome results

None listed

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