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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT06061666
Eligibility Criteria:
Inclusion Criteria:
* Patients capable of giving informed consent
* Patients undergoing surgery to remove breast tumors and undergoing hormone therapy (any stage)
* Patients who present a score \> 5 on the "Pittsburgh Sleep Quality Index (PSQI)" questionnaire on sleep quality
* Patients aged between 18 and 65 years
Exclusion Criteria:
* Children under 18 and people over 65
* Pregnant or breastfeeding women
* Patients with breast cancer undergoing chemotherapy and/or radiotherapy
* Serious concomitant diseases (other neoplasms, liver failure, renal failure, and hyperthyroidism, ulcerative colitis, Crohn's disease)
* Patients being treated with antibiotics in the month preceding screening
* Patients being treated with drugs that alter the sleep-wake rhythm (anxiolytics, hypnotics, non-benzodiazepine hypnotics, major sedatives, antipsychotics, antiepileptics, opiates)
* Known hypersensitivity to Tilia tomentosa
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06061666
Study Brief:
Protocol Section:
NCT06061666