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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT00527306
Eligibility Criteria:
Inclusion Criteria:
* Patients willing and able to provide written informed consent for the study
* Patients with a history of at least three episodes of minor recurrent aphthous stomatitis (RAS) within the past one year
Exclusion Criteria:
* Patients with a history of other forms of RAS (major, herpetiform)
* Patients who will be using any other vitamins/supplements during the study or those who have used any vitamins/supplements on a regular basis during the 90 days immediately preceding enrollment onto the study (regular use is defined as continuous daily use for at least a two week period)
* Patients who are under the age of 18
* Women who are pregnant or nursing or those who plan to become pregnant
* Patients with a history of gout, kidney stones or iron overload disease
* Patients who currently smoke tobacco products
* Patients who are former smokers who have quit smoking within the past 30 days
* Patients with sulfite allergy
* Patients with a history of any systemic condition associated with oral ulceration. These include: Behcet's syndrome, Sweet's syndrome, Celiac disease, Crohn's disease, ulcerative colitis, HIV infection/AIDS, cyclic neutropenia and PFAPA syndrome (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis)
* Patients on medications commonly associated with causing oral ulceration. These include nicorandil, methotrexate and chemotherapeutic agents used for cancer.
* Patients using oral topical anti-inflammatory agents during the course of the study
* Patients who plan to use any products specifically for management of RAS lesions
* Patients who are routinely using agents that could have an impact on duration of RAS lesions (e.g., antibacterial mouthrinses)
* Patients receiving any other investigational agent during the course of ths study
* Patients with any other condition that might preclude participation in the study in the opinion of the study investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00527306
Study Brief:
Protocol Section:
NCT00527306