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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07306494
Eligibility Criteria:
Inclusion Criteria:
1. Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition \[DSM5\]);
2. self-reported history of disturbed sleep (i.e, all the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, and self-reported total sleep time of ≤6·5 h) on at least three nights per week for at least 3 months before screening;(3) diagnosis of "deficiency of the heart and the spleen pattern" or "Qi deficiency of the heart and gallbladder pattern" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023;
(4) baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.
Exclusion Criteria:
1. self-reported allergy symptoms to any of the ingredients;
2. serious physical sickness;
3. a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy;
4. baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;
5. pregnant women;
6. history of drugs or alcohol abuse/dependence;
7. presence of other sleep disorders including sleep apnoea, restless legs syndrome;
8. night, morning or rotating shift work;
9. participation in concurrent clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT07306494
Study Brief:
Protocol Section:
NCT07306494