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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201412153106N20 |
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Date of registration:
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2014-12-30 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assesment of Satureja khuzestanica topical preparation chemotherapy-induced Mucositis
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Scientific title:
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Assesment of Satureja khuzestanica topical preparation chemotherapy-induced Mucositis |
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Date of first enrolment:
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2014-12-22 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/3125 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr. Mehdi Rajabi
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Address:
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No.99, Yakhchal street, Dr. Shariati Avenue
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 2246 0056 |
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Email:
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mehdirj@aol.co.uk |
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Affiliation:
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Pharmaceutical Sciences branch of Islamic Azad University |
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: consciousness; being literate; chemotherapeutic management with drugs which induce mucositis; no stomatitis; no oral disease; no renal & liver disorders; no auto immune disease and diabetes; no fever and neutropenia; no recieved antibiotic & narcotic analgesic.
Exclusion criteria:
Age minimum:
20 years
Age maximum:
77 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Other diseases of lip and oral mucosa
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Mucositis.
Other diseases of lip and oral mucosa
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Intervention(s)
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Control group: standard drug therapy recommended by the physician
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Treatment - Drugs
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Intervention 1: Intervention group: general oral care with Satureja Khuzestanica oral gel, from the first day up the end of cycle for 3 cycles. Intervention 2: Control group: standard drug therapy recommended by the physician.
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Intervention group: general oral care with Satureja Khuzestanica oral gel, from the first day up the end of cycle for 3 cycles.
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Primary Outcome(s)
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Mucositis. Timepoint: At the end of cycle for 3 cycles. Method of measurement: PROMS and OMAS questionnaires.
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Secondary Outcome(s)
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Mucositis. Timepoint: At the end of cycle for 3 cycles. Method of measurement: PROMS and OMAS questionnaires.
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Source(s) of Monetary Support
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Pharmaceutical Science branch of Islamic Azad University
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Ethics review
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Status: Approved
Approval date:
Contact:
Pharmaceutical Sciences Branch of Islamic Azad University
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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