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:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT04292704
Eligibility Criteria:
200 RVVC patients will be eligible for the trial if they fulfil the following criterion:
1. women aged 18 to 60;
2. chief complaint: vulvar itching, burning pain, sexual intercourse pain and urine pain, leucorrhea increased, occurring 4 or more times a year;
3. gynecological examination: vulvar erythema, edema, often accompanied by scratches, vaginal mucosa red and swollen, the inside of the labia minor and vaginal mucosa with white lumps, curd or bean curd-like, red and swollen mucous membrane exposed after erasure;
4. laboratory examination: microscopic examination of vaginal secretions to find the spores or hyphae of Candida albicans;
5. sign the informed consent form voluntarily.
5 healthy volunteers as the normal control group will be eligible for the trial if they fulfil the following criterion:
1. women aged 18 to 60;
2. no clinical symptoms;
3. vaginal cleanliness grade Ⅰ \~ Ⅱ;
4. laboratory examination: Candida spores or hyphae were not found in vaginal secretions;
5. menstruation was normal;
6. voluntary informed consent was signed.
Exclusion criteria:
1. those who did not meet the above inclusion criteria;
2. those with autoimmune or immunodeficiency diseases;
3. those who received antibiotics or antifungal therapy (including systemic and topical);
4. and special drugs and foods within 1 month;
5. women during lactation and pregnancy;
6. patients with liver insufficiency, neutropenia, adrenocortical dysfunction and diabetes;
7. those who are mentally abnormal and can not cooperate normally;
8. those who are allergic to clotrimazole vaginal tablets or other imidazole drugs.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04292704
Study Brief:
Protocol Section:
NCT04292704