A real-world study to evaluate the efficacy and safety of Tianmeng Oral Liquid in the treatment of insomnia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026001005

Enrollment

Unknown

Registered

2026-04-17

Start date

2024-06-17

Completion date

Unknown

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Research Group:Combined therapy of Tianmeng Oral Liquid and conventional Western medicine

Control Group:conventional Western 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 other conventional Western medicines. 5.Voluntarily agree to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Subjects with contraindications to Tianmeng Oral Liquid and other study medications. 2.Pregnant or lactating women, or women planning pregnancy. 3.Subjects deemed ineligible 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;	—

Countries

China

Contacts

Public ContactGuo Rong Juan

Dongfang Hospital, Beijing University of Chinese Medicine

dfguorongjuan@163.com18611377633

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026