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Investigation of Calendula officinalis extract on radiotherapy-induced oral mucositis

Investigation of Calendula officinalis extract on radiotherapy-induced oral mucositis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201106076734N1
Enrollment
40
Registered
2011-06-13
Start date
2008-02-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Oral Mucositis. Other and unspecified lesions of oral mucosa

Interventions

Intervention 1: A gel which was equalized in taste, odor, shape and color to 2% Calendula mouthwash was used as a placebo mouthwash. Patients were instructed to use the mouthwash 3 three times daily f
Placebo
Treatment - Drugs
A gel which was equalized in taste, odor, shape and color to 2% Calendula mouthwash was used as a placebo mouthwash. Patients were instructed to use the mouthwash 3 three times daily from onset of rad
Herbal extract of plant Calendula officinalis was added to a basic gel to make 2% calendula mouthwash. Patients were instructed to use the mouthwash 3 three times daily from onset of radio-therapy for

Sponsors

Vice chancellor for research, Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Minimum accumulative dose of 40 Gy according to treatment protocol; 2) Complete exposure of oral field to x ray; 3) Minimum age of 45; Exclusion criteria were: 1) Pregnancy; 2) Allergy to the mouthwash; 3) Preexisting oral conditions; 4) Use of other medications related to oral mucositis during study period; 5) Any systemic diseases interfering with healing

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Intensity of oral mucositis. Timepoint: at the end of each week for total of 6 weeks for each patient. Method of measurement: Oral Mucositis Assessment Scale (OMAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Babaee

Department of oral diseases, Dental School of Babol University of Medical Sciences

n.babaee@mubabol.ac.ir; dr_nedababaee@yahoo.com+98 11122914089

Outcome results

None listed

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