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NCT05045443 Clinical Trial

Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

— CurcumPedALL  

Official title:
Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05045443
Other study ID # FMASU MD 134/2021
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 22, 2021
Est. completion date January 4, 2024

Study information
Verified date January 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of of the biological effects of curcumin on microbiota in children with acute lymphoblastic leukemia

Description:

Assessment of the safety of curcumin, which is the most active constituent of the ground rhizome of the Curcuma longa plant, in children with acute lymphoblastic leukemia patients (ALL) in maintenance phase of chemotherapy through the assessment of the any reported adverse event (AE). And assessment of the curcumin effect on health by eliminating intestinal microflora dysbiosis

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 4, 2024
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: Children aged from 1 year to 18 years Children with proven ALL diagnosed by bone marrow aspirate and immunephenotyping Patients in the maintenance phase week1 Exclusion Criteria: Children with other maliganacies, Current use (past use of these medications is not an exclusion) of medications or over-the-counter treatments including to sulfasalazine, warfarin, clopidogrel, aspirin, antacids, botanical treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula species, and Gaultheria species), essential fatty acids (flax oil and fish oil).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Curcumin
Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement
Dietary Supplement:
• Standard of Care
As per institution protocol for Standard of nutritional Care

Locations
Country Name City State
Egypt Pediatric Hematology Oncology and BMT Unit, Faculty of Medicine Ain Shams University Cairo Non-US

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the Safety of curcumin in pediatric patients with ALL. Percentage of patients who developed adverse event 4 weeks
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