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A clinical study on the safety and efficacy of a mucoadhesive oral rinse containing Triphala extract for the prevention of oral mucositis in cancer patients at Siriraj hospital

A clinical study on the safety and efficacy of a mucoadhesive oral rinse containing Triphala extract for the prevention of oral mucositis in cancer patients at Siriraj hospital

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260130005
Enrollment
64
Registered
2026-01-30
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Adult cancer patients receiving chemotherapy. Hospitalized patients for bone marrow transplantation mucositis Triphala extract mucoadhesive

Interventions

Mucoadhesive Triphala extract Oral rinse 4 times a day for 21 days ,Betadine oral rinse and oral hygiene
Experimental Other,Active Comparator Other
Triphala extract,Standard of care

Sponsors

Agricultural Research Development Agency
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.18 years old or older 2.multiple myeloma patients receiving high dose melphalan as chemotherapy. 3.Hospitalized patients in the bone marrow transplantation unit. 4.Eastern Co-operation Oncology Group Performance Status (ECOG-PS) from 0-2 5.No history of mucositis 6.Ability to provide informed consent.

Exclusion criteria

Exclusion criteria: 1.Known allergy to herbal products or components of the investigational product. 2.Unable to use products as directed

Design outcomes

Primary

MeasureTime frame
overall incidence of all grade mucositis at 14 days 14 days after intervention number of patients

Secondary

MeasureTime frame
overall incidence of all grade mucositis 7 and 21 days after intervention number of patients ,pain score (if any) day 1-21 pain score from 1-10 ,incidence of oral infection day 1-21 number of patients ,time to mucositis day 1-21 time (days),incidence of adverse reaction day 1-21 number of ADR

Countries

Thailand

Contacts

Public ContactJennis Meanwatthana

Mahidol University

jennis.mea@mahidol.ac.th026448694

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026