- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01732393
Effect of Quercetin in Prevention and Treatment of Oral Mucositis
December 4, 2012 updated by: Pegah Mosannen Mozafari, Mashhad University of Medical Sciences
Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias
The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Khorasan Razavi
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MAshhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-498
- Oral Medicine Department of Mashhad dental School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patient under chemotherapy
- for a hematologic malignancy
- the hematologist permits the trial on the patient
- agreement of patient for participating in the trial
Exclusion Criteria:
- presence pf ANY oral lesion at the beginning of the trial
- loss of follow up
- use of digoxin and cyclosporine
- patient death
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: oral quercetin capsules
Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks
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10 cases in case group and 10 cases in control group.
Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks.
Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.
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Placebo Comparator: oral placebo capsules
Patients in the placebo group received two placebo capsules containing lactose .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lower grade of mucositis
Time Frame: 3 weeks
|
grade of mucositis due to WHO criteria
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of mucositis
Time Frame: 3 weeks of study tiem span and after trial
|
duration of mucositis due to Who criteria
|
3 weeks of study tiem span and after trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Pegah Mosannen Mozafari, assistant professor, Mashhad University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 19, 2012
First Submitted That Met QC Criteria
November 21, 2012
First Posted (Estimate)
November 22, 2012
Study Record Updates
Last Update Posted (Estimate)
December 5, 2012
Last Update Submitted That Met QC Criteria
December 4, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 89470
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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