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?Effectiveness of f Colon Specific Oral Formula containing Malva sylvesteris extract on Irritable Bowel Syndrome

Clinical Evaluation of Colon Specific Oral Formula containing common mallow (Malva sylvestris) extract as a supplement for treatment of Irritable Bowel Syndrome in Adults Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120305009204N4
Enrollment
50
Registered
2019-08-24
Start date
2019-07-30
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Ulcerative colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: This group will receive colon specific tablets at the dose of 400 mg dried extract of Malva sylvestris, twice a day for 1 months, in adjunct to the routine treatmen

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Medium or mild left sided colitis

Exclusion criteria

Exclusion criteria: Age under 18 and over 70 years Addiction Unwillingness to attend or continue to study pregnacy history of allergy to common mallow Taking prednisolone above 15 mg daily and/or cyclosporine and/or infliximab within a month before intervention Taking CNi; anti TNF; 6 MP or any antibiotics within a month before intervention suffering from other inflammatory or non-infammatory bowel diseases such as neoplasms (observation of dysplasia in the tissue samples), polyposis, etc.

Design outcomes

Primary

MeasureTime frame
C-reactive protein (C-RP) level. Timepoint: Before intervention and four weeks after intervention initiation. Method of measurement: Laboratory test.;Level of calpertectin in patients stool sample. Timepoint: Before intervention and four weeks after intervention initiation. Method of measurement: EISA Kit.

Secondary

MeasureTime frame
Quality of life. Timepoint: Before and four weeks after intervention initiation. Method of measurement: Through the Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQOL).;Complete blood count (CBC). Timepoint: Before and four weeks after intervention initiation. Method of measurement: Laboratory test.;Level of IL-6 in patients serum. Timepoint: Before and four weeks after intervention initiation. Method of measurement: ELISA Kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Azadeh Hamedi

Shiraz University of Medical Sciences

hamediaz@sums.ac.ir+98 71 3242 4127

Outcome results

None listed

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