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Effect of an product derived from plantago ovata in the treatment of radiotherapy induced diarrhea

Clinical evaluation of an Iranian traditional product (derived from plantago ovata) in the treatment of radiotherapy induced diarrhea Grade 1 to Grade 3

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015083123823N1
Enrollment
62
Registered
2015-10-25
Start date
2015-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

radiotherapy induced diarrhea. Gastroenteritis and colitis due to radiation

Interventions

Intervention 1: samples select from target population that assign at least 31patients to each of two treatment arms. Patients in interventional group receive traditional drug ,paste product,12.5 gr tw
Treatment - Drugs
samples select from target population that assign at least 31patients to each of two treatment arms. Patients in interventional group receive traditional drug ,paste product,12.5 gr two times daily fo
Patients in control group receive loperamide in a standard dosage(2 mg per every bowel habit with maximum daily dose12 mg) for one week.

Sponsors

Shiraz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Number of loose bowel movement (stool). Timepoint: daily. Method of measurement: visual by paitent.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTavakoli Ali

Shiraz University Of Mdical Sciences

tavakkolia@sums.ac.ir+98 71 3233 1028

Outcome results

None listed

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