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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT04980703
Eligibility Criteria:
Inclusion Criteria:
1. Meet the diagnostic criteria of insomnia;
2. TCM syndrome differentiation belongs to deficiency of both heart and spleen;
3. Male or female participants aged 18-75;
4. Participants whose PSQI score is 5-15;
5. The course of disease is more than 3 months;
6. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
Exclusion Criteria:
1. Participants with mental retardation;
2. Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;
3. Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);
4. Female participants who is pregnant or lactating;
5. Participants with diabetes and sensory dysfunction.
6. Participants with skin diseases of acupoints;
7. Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;
8. Participants with dependence on sleeping drugs;
9. Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04980703
Study Brief:
Protocol Section:
NCT04980703