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Evaluation of the efficacy of Maa-al-shaeer (product based on barley seeds) on radiotherapy induced dysuria

Phase 3
Recruiting
Conditions
Prostate Cancer, Radiotherapy-induced dysuria, Urogenital radiotherapy complications.
C61
Malignant
Registration Number
IRCT20190608043840N1
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
70
Inclusion Criteria

Over 18 years old
Prostate cancer
Candidate for radiation therapy (at the Radiotherapy Center of Shohada-e-Tajrish Hospital)
Consciousness

Exclusion Criteria

Unconsciousness or unable to report dysuria
Urinary catheter
Urinary tract infection
Diabetes Mellitus
Dysuria
A history of drug sensitivity
Metastasis
Chemotherapy at the same time
Hematuria
Severe Cardiovascular, Pulmonary, Hepatic and Kidney diseases that need some medical treatments
Not participating in the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dysuria. Timepoint: Before intervention and 2, 4, 6, 8 weeks after intervention. Method of measurement: IPSS (International prostate symptom score) questionnaire.
Secondary Outcome Measures
NameTimeMethod
Quality of Life. Timepoint: Quality of life score before the intervention (week 0) 4 and 8 weeks after the intervention. Method of measurement: EORTC QLQ-PR25 Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Prostate Cancer).;The number of phenazopyridine tablets which was used. Timepoint: 2, 4, 6 and 8 weeks after the intervention. Method of measurement: Asking the participants.;Treatment satisfaction. Timepoint: 8 weeks after the intervention. Method of measurement: It is measured by asking 1 Likert scale question (very high, high, medium, low and very low).
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