Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT02300727
Eligibility Criteria:
Inclusion Criteria:
* ≥ grade 2 oral mucositis related to chemotherapy for cancer
* Ability to understand and the willingness to review and sign a written informed consent document.
* ≥ 18 years of age
* Willingness to use adequate contraception prior to study entry, for the duration of study participation and for 30 days after the last dose for women of child-bearing potential and men
Exclusion Criteria:
* Current use of therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (prophylactic doses and agents are acceptable)
* Biliary tract obstruction or cholelithiasis
* History of gastric or duodenal ulcers or hyperacidity syndromes
* AST or ALT \> 2 x ULN
* Total bilirubin ≥ 2 x ULN
* INR \> 1.5
* Previous stem cell transplant (allogeneic or autologous)
* Preexisting oral disease, such as active oral infection, trauma to the oral mucosa or oral - ulceration prior to chemotherapy
* Known allergy/hypersensitivity to curcumin, yellow food coloring, or other members of the - Zingiberaceae (ginger) family
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02300727
Study Brief:
Protocol Section:
NCT02300727