Salvizan gel effect in prevention of chemotherapy-induced oral mucositis

Evaluation of the effectiveness of Salvizan gel in prevention of chemotherapy-induced oral mucositis (a randomized, double blind, placebo controlled clinical trial)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211029052907N4

Enrollment

Registered

2024-10-22

Start date

2024-10-22

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Oral mucositis. Oral mucositis (ulcerative)

Interventions

Intervention 1: Intervention group: Salvizan gel is produced by Gol Daru pharmaceutical company contains 28% hydroalcoholic extract of Salvia officinalis.The use of the drug will be started from the f

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: age above 18 years diagnosed with colorectal cancer and Planned for receiving 5-Fluorouracil chemotherapy regimens Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2

Exclusion criteria

Exclusion criteria: Know hypersensitivity history to Salvia officinalis or any other ingredients of the gel oral sores or mucositis before chemotherapy initiation using dentures history of infective, systemic or autoimmune diseases with oral lesions

Design outcomes

Primary

Measure	Time frame
Incidence time of oral mucositis. Timepoint: Daily for three weeks from the start of chemotherapy. Method of measurement: the standardized oral assessment questionnaire.;Oral mucositis severity. Timepoint: Daily for three weeks from the start of chemotherapy. Method of measurement: World Health Organization (WHO) grading system.;Pain. Timepoint: Daily for three weeks from the start of chemotherapy. Method of measurement: Visual Analogue Scale.	—

Measure

Time frame

Incidence time of oral mucositis. Timepoint: Daily for three weeks from the start of chemotherapy. Method of measurement: the standardized oral assessment questionnaire.;Oral mucositis severity. Timepoint: Daily for three weeks from the start of chemotherapy. Method of measurement: World Health Organization (WHO) grading system.;Pain. Timepoint: Daily for three weeks from the start of chemotherapy. Method of measurement: Visual Analogue Scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Maham

Zanjan University of Medical Sciences

maham.monireh@gmail.com+98 24 3347 3635

Outcome results

None listed

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