Effect of Maqliasa capsule on ulcerative colitis

Phase 2

Conditions: lcerative colitis.
Ulcerative colitis

Registration Number: IRCT2017042719489N2

Lead Sponsor: Barij Essence Pharmaceutical Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 15

Inclusion Criteria

1- The study is accomplished in patients suffer from ulcerative colitis confirmed by colonoscopy
2- Age limit between 18 to 70 y/o
3- No pregnancy
4- No breastfeeding
5- No history of peptic ulcer
6- No history of toxic megacolon
7- No history of colon cancer
Exclusion criteria:
1- Appearance of peptic ulcer manifestations
2- Emergence of severe drug complications

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diarrhea (Number of daily stools). Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Patient statements.;Nocturnal diarrhea. Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Patient statements.;Fecal incontinence. Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Patient statements.;Abdominal pain or cramping. Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Patient statements.;General well-being. Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Patient statements.;Abdominal tenderness. Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Physical exam.;Need for anti-diarrhea drugs. Timepoint: Onset of intervention, 14 and 28 days later. Method of measurement: Patient statements.

Secondary Outcome Measures