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Clinical study protocol of Jieyu pill on the rehabilitation of patients with COVID-19

Clinical study protocol of Jieyu pill on the rehabilitation of patients with COVID-19

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000736
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-02-06
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Insomnia and anxiety

Interventions

Group 1 :Jieyu pills plus escitalopram oxalate tablets
Group 2:Escitalopram oxalate tablets alone

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Insomnia and anxiety after COVID-19 infection. (2) Male and female aged 18-65 years. (3) The symptoms of the patient appeared after COVID-19 infection including sleep mood disorders depression anxiety insomnia and fatigue as the main clinical symptoms. (4) HAMA score > 14 indicating mild to moderate anxiety. (5) Consistent with the diagnosis of TCM liver depression and qi stagnation. (6) Patients were informed signed the informed consent and could be followed up with good compliance. (7) No other other anti-anxiety and depression drugs in the past 4 weeks.

Exclusion criteria

Exclusion criteria: (1) Patient with serious heart brain respiratory digestive endocrine blood liver and kidney diseases; (2) Patients with a history of mental illness disturbance of consciousness cognitive impairment or other reasons were unable to cooperate with the researcher; (2) Pregnant or lactating women; (3) Long-term alcoholism and drug dependence; (4) Ppatients with allergic constitution or allergic to drug components.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale (HAMA);

Secondary

MeasureTime frame
Insomnia Severity Index (ISI);Hamilton Depression Scale (HAMD);Quantitative criteria for TCM syndrome grading;Quality of life Scale;Health Questionnaire-15 Somatic Symptom Cluster Scale (PHQ-15);Polysomnography was performed;

Countries

China

Contacts

Public ContactXu Liran

The First Affiliated Hospital of Henan University of Chinese Medicine

xuliran666@sina.com+86 13633818030

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026