The efficacy of " Xuan Yù Hé Jì "combined with Cognitive Behaviour Therapy (CBT) on treating post COVID-19 mild and moderate depressive disorder: a randomized, double-blind, placebo-controlled clinical trial

The efficacy of " Xuan Yù Hé Jì "combined with Cognitive Behaviour Therapy (CBT) on treating post COVID-19 mild and moderate depressive disorder: a randomized, double-blind, and placebo-controlled clinical trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072138

Enrollment

Unknown

Registered

2023-06-05

Start date

2023-02-22

Completion date

Unknown

Last updated

2023-06-12

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

Conditions

Depressive Disorder

Interventions

Experimental Group:Cognitive Behaviour Therapy+“Xuan Yù Hé Jì”

Control group:Cognitive Behaviour Therapy+Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Participant meets the diagnosis of COVID-19 cases and discharge criteria according to China COVID-19 protocol (9th edition),and are within 3 months of discharged. 2. Participant meets the diagnosis of mild and moderate depressive disorder according to the Diagnosis and Treatment Scheme for Depressive Disorder of TCM, consistent with the Traditional Chinese Internal Medicine of the Shanghai Municipal Hospital of Traditional Chinese Medicine. 3. Participant meets the diagnosis of mild and moderate depression disorder according to World Health Organization's International Classification of Diseases (ICD)-11 ,Hamilton Depression Scale (HAMD) score of =7and =17. 4. Aged 18 to 70 years, both male and female, able to express and cooperate during the treatment and survey. 5. Participants who volunteered to be in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Participant who is not applicable to the inclusion criteria 2.Participant who has organic mental disorder, or depression caused by psychoactive substances and non-addictive substances 3.Participant allergic to the medication used in the study 4.Participant who is currently pregnant, lactating or is of childbearing potential and is not willing or unable to cease contraceptive use during the study 5.Participant with obvious heart, liver, kidney, mental or other severe primary disease. 6.Participant who is drug and medicine abuse 7.Participant who has participated in other drug clinical trials within the previous 4 weeks

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Scale;	—

Secondary

Measure	Time frame
TCM symptom score;Metabolite and Metabolism Pathway;	—

Countries

China

Contacts

Public ContactWenjing Zhang

Shanghai Municipal Hospital of Traditional Chinese Medicine

carrie1072@sina.com+86 186 1636 0246

Outcome results

None listed

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