The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05091775

Collaborator

(none)

140

Enrollment

Location

Arms

7.3

Actual Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase.

The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing.

This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.

Condition or Disease	Intervention/Treatment	Phase
Fissure in Ano Diarrhea	Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease	Phase 1/Phase 2

Detailed Description

The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)

Masking:

Single (Care Provider)

Masking Description:

Double blind

Primary Purpose:

Treatment

Official Title:

The Evaluation of the Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure in Post-Chemotherapy Cancer Patients - A Randomized Controlled Trial

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Aug 2, 2020

Actual Study Completion Date :

Jan 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath) Patients in the first group underwent for 14 consecutive days treatment with diltiazem gel 2 times a day, a basin of warm water 2 times a day and drink daily 8-12 a glass of water will be placed with a placebo suppository.	Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms. Other Names: Mesalazine is used to treat and prevent mild to moderate acute fissure disease
Experimental: Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath) Patients in the second group or treatment group will be treated with diltiazem gel topically 3 times a day for 14 consecutive days, pelvis of warm water 2 times a day and drink daily 8-12 glasses of water plus Asacol anal suppository (mesalazine) are taken 1 piece every night.	Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms. Other Names: Mesalazine is used to treat and prevent mild to moderate acute fissure disease

Arm

Intervention/Treatment

Placebo Comparator: Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath)

Patients in the first group underwent for 14 consecutive days treatment with diltiazem gel 2 times a day, a basin of warm water 2 times a day and drink daily 8-12 a glass of water will be placed with a placebo suppository.

Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.

Other Names:

Mesalazine is used to treat and prevent mild to moderate acute fissure disease

Experimental: Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)

Patients in the second group or treatment group will be treated with diltiazem gel topically 3 times a day for 14 consecutive days, pelvis of warm water 2 times a day and drink daily 8-12 glasses of water plus Asacol anal suppository (mesalazine) are taken 1 piece every night.

Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Other Names:

Mesalazine is used to treat and prevent mild to moderate acute fissure disease

Outcome Measures

Primary Outcome Measures

Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath) [2 weeks]
bleeding anal fissure. After 2weeks the patients will visit. The score of pain, burning sensation, bleeding and improvement will be recorded in two groups. Score of pain with visual analog scale (VAS) is a tool widely used to measure pain; Scale (0-10) that higher grade means higher pain. Burning sensation (yes, no) and bleeding (yes, no) and improvement (yes, no) will be recorded

Secondary Outcome Measures

Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath) [3 months]
need surgery or botox injection. Both group including 70 patients that will visit after 2 weeks for evaluating heading acute fissure by history and physical examination. Bleeding(decrease/increase) Pruritus(decrease/increase) Wound healing (according to surgeon evaluation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For age between 18 and 65 years are the presence of acute anal fissure (with symptoms less than 6 weeks) following chronic diarrhea and subsequent fissure.