Evaluating effects of Sodium Hyaluronate and four amino acids in oral mucositis prevention

Evaluating the effects of a combined product of Sodium Hyaluronate, Glycine, L-Proline, L-Leucine, L-Lysine in preventing the occurrence of Oral Mucositis in pediatric Hematopoietic Stem Cell Transplant patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190917044805N1

Enrollment

Registered

2019-12-05

Start date

2019-12-21

Completion date

Unknown

Last updated

2019-12-17

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), unspecified

Interventions

Intervention 1: Intervention group: patients in this group will receive topical mucosamine spray manufactured by Professional Dietetics Italy, four times daily 7 days before receipt of hematopeitic st

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age below 18 years old Undergoing allogenic hematopeitic stem cell transplantation

Exclusion criteria

Exclusion criteria: Patients with active oral mucositis at the time of admission History of hypersensitivity reactions to mucosamine spray or any of its ingreedients Patients with the diagnosis of fanconie's anemia

Design outcomes

Primary

Measure	Time frame
Oral mucositis severity. Timepoint: every other day, since the day of admission till the day of discharge. Method of measurement: National Cancer Institute Common Terminology of Adverse Events criteria version 5.	—

Secondary

Measure	Time frame
Mucositis incidence. Timepoint: Every other day. Method of measurement: Observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactkurosh sadeghi

Tehran University of Medical Sciences

sadeghi_k@tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 17, 2026