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Usage of turmeric extract to prevent severe oral mucosal ulcerations in children and adolescents with blood cancer receiving chemotherapy medicine named methotrexate

Prophylactic effect of curcumin lozenges on incidence and severity of mucositis in children and adolescents Receiving High-Dose Methotrexate for Hematolymphoid malignancies: A Single Centre - Randomized Double arm study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109521
Enrollment
38
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Interventions

None listed

Sponsors

PHARMANZA HERBAL PVT. LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 3 to 18 years with diagnosis of hematolymphoid malignancy like acute lymphoblastic leukemia, Lymphoblastic Lymphoma and receiving high-dose methotrexate 3 to 5 g/m over 24-hour infusion

Exclusion criteria

Exclusion criteria: Known hypersensitivity to curcumin- by asking if the child is allergic to turmeric Ongoing severe gastrointestinal symptoms or vomiting precluding oral administration Concurrent participation in another mucositis interventional study. Those in whom mucositis of any grade already persists during the start of HDMTX Those in whom consent is denied Patients with Diabetes Mellitus or with prior immunosuppressive disorder of any kind Down syndrome Those who can t tolerate Lozenges

Design outcomes

Primary

MeasureTime frame
To evaluate whether prophylactic curcumin lozenges reduce the incidence of oral mucositis [ Grade I to IV] in children and adolescents receiving high dose methotrexate compared to current standard of careTimepoint: 0- At baseline; Prior to starting of chemotherapy 8 days- After delivery of chemotherapy 14 days- After delivery of chemotherapy—

Secondary

MeasureTime frame
To evaluate the role of curcumin in reducing the severity of oral mucositis- Grade III & above vs Grade III & below Determine the need & duration of TPN due to poor oral intake Whether TPN is required or not- If needed for how many days Assess opioid analgesia requirement & duration in both groups - Whether opioids are required or not- if needed the number of days Evaluate pain scores- Using visual analogue scales Timepoint: 0- At baseline; Prior to starting of chemotherapy 8 days- After delivery of chemotherapy 14 days- After delivery of chemotherapy—

Countries

India

Contacts

Public ContactDr Vasudeva Bhat K

Kasturba Medical College, Manipal

nikithagokiani@gmail.com6364357585

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026