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Comparison the effect of saffron extract with artificial saliva on alleviation of oral mucositis caused by head and neck radiotherapy: a randomized trial

Comparison the effect of saffron extract with artificial saliva on alleviation of oral mucositis caused by head and neck radiotherapy: a randomized trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221207056743N1
Enrollment
62
Registered
2023-03-29
Start date
2023-04-09
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Oral mucositis. ????? ??

Interventions

Intervention 1: Intervention group: the group receiving common treatments to prevent mucositis plus receiving a daily puff of saffron, which is equivalent to 100 milligrams of saffron with a concentra

Sponsors

Ghoum University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: People's satisfaction with the trial Patients with head and neck cancers undergoing radiotherapy Have received at least 36-40 Gy of radiation At least 4 weeks have passed since the start of their radiotherapy treatment. Not allergic to saffron Absence of heart diseases and blood pressure

Exclusion criteria

Exclusion criteria: Suffering from other oral and dental diseases. Long-term use of anti-coagulant and anti-platelet drugs. Systemic conditions such as pregnancy and breastfeeding, diabetes, hypertension, autoimmune diseases, GVHD, use of saliva reducing drugs, alcohol use, drug addiction, bone marrow transplantation, active lesion, oral infection and mucosal wounds before starting radiotherapy Lack of consent to continue the trial and lack of consent to continue the treatment. Performing any surgery and trauma Suffering from any heart, liver and kidney failure and any disease that has manifestations similar to oral mucositis.

Design outcomes

Primary

MeasureTime frame
Oral mucositis score. Timepoint: Start time, day 7?14?21?28. Method of measurement: WHO definition of oral mucositis grading: 0_none 1_pain and redness 2_redness, wound, ability to eat solid foods 3_wound, need for liquid diet 4_feeding impossible.;Pain sevirity. Timepoint: Start time, day 7?14?21?28. Method of measurement: Pain Visual analogue scale.;Teeth color. Timepoint: Starting day and day 28. Method of measurement: Vita shade guide.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Zahra Shafiee

Ghoum University of Medical Sciences

fzshafiee98@gmail.com+98 25 3355 0312

Outcome results

None listed

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