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The effect of saffron on mucositis

Evaluation of the effectiveness of mucoadhesive mouthwash containing saffron petal extract on prevention and improvement of clinical symptoms of radiotherapy-induced oral mucositis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180103038199N6
Enrollment
40
Registered
2021-06-10
Start date
2024-11-21
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Radiotherapy-induced oral mucositis. Oral mucositis (ulcerative) due to radiation

Interventions

Intervention 1: Control group: Receiving routine treatment (Acetaminophen 500 mg three times a day, Made by Jalinous company) + placebo mouthwash containing distilled water and glycerin twice a day ma

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients treated for head and neck cancer with chemo-radiotherapy Age between 18 and 70 years Absence of serious dental problems Absence of impacted teeth No cusp or sharp filling Total radiation is between 50 and 70 Gy during treatment Exposure of at least half of the oral cavity to radiation Patients should take one of the drugs cisplatin or 5-fluorouracil in their chemotherapy regimen.

Exclusion criteria

Exclusion criteria: Severe infections that require antibiotics. Patients who have been allergic to any of the herbal extracts or previous radiotherapy Inability of the patient to implement the treatment protocol Renal failure (eGFR <50 ml / min) Liver failure (serum level 2 to 3 times higher than normal)

Design outcomes

Primary

MeasureTime frame
Change in mucositis score based on World Health Organization scoring. Timepoint: Every week from the beginning of the drug (week zero) to the end of the study (week seven). Method of measurement: World Health Organization mucositis scoring questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Vahid Reza Askari

Mashhad University of Medical Sciences

askariv@mums.ac.ir+98 915 371 9688

Outcome results

None listed

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