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CompletedNCT01732393Updated Dec 5, 2012

Effect of Quercetin in Prevention and Treatment of Oral Mucositis

A Phase 1/2 interventional study of oral quercetin capsules and Placebo in Chemotherapy Induced Oral Mucositis, sponsored by Mashhad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-12-05.

Sponsored by Mashhad University of Medical Sciences · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
15 Years to 40 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chemotherapy Induced Oral Mucositis

Keywords

  • Quercetin
  • Chemotherapy
  • Mucositis
  • Hematologic Malignancies
03

In context

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 394 interventional studies indexed under Mucositis.

Browse Mucositis studies →

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • presence pf ANY oral lesion at the beginning of the trial
  • loss of follow up
  • use of digoxin and cyclosporine
  • patient death
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    oral quercetin capsules

    Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks

    Drug: oral quercetin capsules

  • Placebo comparator
    oral placebo capsules

    Patients in the placebo group received two placebo capsules containing lactose .

    Drug: Placebo

Interventions

  • Drugoral quercetin capsules

    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.

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. lower grade of mucositis

    grade of mucositis due to WHO criteria

    Time frame: 3 weeks

Secondary outcomes

  1. duration of mucositis

    duration of mucositis due to Who criteria

    Time frame: 3 weeks of study tiem span and after trial

07

Study locations

1 site
  • Oral Medicine Department of Mashhad dental School
    MAshhad, Khorasan Razavi 91735-498, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01732393
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
Pegah Mosannen Mozafari (assistant professor of oral medicine, Mashhad University of Medical Sciences) — Principal investigator
First posted
Nov 22, 2012
Start date
Jan 2010
Primary completion
Oct 2011
Completion
Jan 2012
Last update
Dec 5, 2012

Study contacts

Pegah Mosannen Mozafari, assistant professor
study director · Mashhad University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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