Insomnia
Conditions
Interventions
Research Group:Tianmeng Oral Liquid
Control Group:Wuling Capsule
Sponsors
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–75 years, with no gender restriction. 2.Clinically diagnosed with insomnia. 3.Traditional Chinese Medicine (TCM) syndrome differentiation: deficiency of both heart and spleen, disharmony between heart and kidney, or deficiency of heart-gallbladder qi. 4.Receiving treatment with Tianmeng Oral Liquid or Wuling Capsule. 5.Voluntarily agree to participate in this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications to Tianmeng Oral Liquid or other study medications. 2.Pregnant or lactating women, or women with pregnancy plans. 3.Patients who are currently taking regular medications for insomnia, depression, anxiety, or other central nervous system–acting drugs, or receiving psychological or physical therapy, and cannot discontinue such treatments during the study period. 4.Patients considered ineligible for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PQSI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PQSI score;Clinical response rate;Change in ISI score;Change in individual factor scores of PQSI;Change in sleep diary parameters;Change in TCM syndrome score;Comparison of dosage of rescue medication;Proportion of subjects taking rescue medication; | — |
Countries
China
Contacts
Public ContactWang Jia
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed