Use of Curcumin to Reduce ulcers in Gut in patients undergoing Autologous Bone Marrow Transplant

A Phase III Randomized DoubleBlind Placebo Controlled Study of Curcumin to Reduce Mucositis in Autologous Transplant Setting

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015846

Enrollment

190

Registered

2018-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K123- Oral mucositis (ulcerative) Health Condition 2: D70-D77- Other disorders of blood and blood-forming organs

Interventions

Intervention1: curcumin: one group of patients through randomization will receive curcumin lozenges Control Intervention1: curcumin and placebo: Curcumin lozenges will be given to one group of patient

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients 18 years and above Patients who give written informed consent Patients with performance status â?? 0,1 or 2 (ECOG scale) Patients requiring autologous transplant for any malignant disease with any of the following high dose chemotherapy regimens Melphalan- 200 mg/m2 or more (MEL-200 mg/m2) Busulfan and Melphalan (BuMEL) Carmustine (BCNU), Etoposide, Cytosine Arabinoside and Melphalan ( BEAM) Patients who have creatinine clearance > 50 ml/min Patients with serum bilirubin levels < 2mg/dl. and serum liver enzymes (ALT or AST or both) lesser than 5 times the upper limit of normal value

Exclusion criteria

Exclusion criteria: Patients who are on NSAIDs, aspirin, antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week. Patients being treated for active infection at the time of starting high dose chemotherapy.

Design outcomes

Primary

Measure	Time frame
Incidence of grade 3 and 4 oral mucositis in both groupsTimepoint: from day of transplant to 28 days post transplant	—

Secondary

Measure	Time frame
Incidence of any grade of oral mucositis. Duration of grade 3 and 4 oral mucositis in both groups. Incidence and duration of use of Total Parenteral Nutrition in both groups. Levels of salivary and serum cytokines at different time points in both groups. Duration of use of analgesics for pain due to oral mucositis in both groups. Incidence of grade 3 and 4 nausea and vomiting in both groups. Incidence of grade 3 and 4 diarrhea in both groups. Duration of hospital stay in both groups. Timepoint: from day of transplant to 28 days post transplant	—

Measure

Time frame

Incidence of any grade of oral mucositis. Duration of grade 3 and 4 oral mucositis in both groups. Incidence and duration of use of Total Parenteral Nutrition in both groups. Levels of salivary and serum cytokines at different time points in both groups. Duration of use of analgesics for pain due to oral mucositis in both groups. Incidence of grade 3 and 4 nausea and vomiting in both groups. Incidence of grade 3 and 4 diarrhea in both groups. Duration of hospital stay in both groups. Timepoint: from day of transplant to 28 days post transplant

—

Countries

India

Contacts

Public ContactDr Navin Khattry

Professor Department of Medical Oncology BMT Unit

nkhattry@gmail.com02227405000

Outcome results

None listed

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