Effect of an product derived from plantago ovata in the treatment of radiotherapy induced diarrhea
Phase 2
- Conditions
- radiotherapy induced diarrhea.Gastroenteritis and colitis due to radiation
- Registration Number
- IRCT2015083123823N1
- Lead Sponsor
- Shiraz University Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Patients with Grade 1 to Grade 3diarrhea, as described in Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 and experienced during the 24-h period after a fraction of radiotherapy ;All patients had a histologically confirmed cancer ;age>18 years; absence of fever with white blood cell count of over 3,000/mm3.
exclusion criteria: Patients with Grade 4 diarrhea; diarrhea or stool incontinence before the beginning of irradiation; renal failure; past history of gastrointestinal
disorder known to cause diarrhea ;presence of an active intraluminal gastrointestinal tumor
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of loose bowel movement (stool). Timepoint: daily. Method of measurement: visual by paitent.
- Secondary Outcome Measures
Name Time Method Duration of diarrhea therapy. Timepoint: daily. Method of measurement: Recorded by patients in a special card.;Side effects. Timepoint: daily. Method of measurement: Recorded by patients in a special card.