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Real-world study on anti-depressive effects of Chinese medicine classic compound prescriptions based on the theory of Qi-Yu and Qi-Xu leading to depression.

Real-world study on anti-depressive effects of Chinese medicine classic compound prescriptions based on the theory of Qi-Yu and Qi-Xu leading to depression.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000210
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Depression

Interventions

Experimental Group I:Anshen Jieyu Granules + Real-World Treatment
Control group 1:Placebo plus real-world treatment
Experimental Group 2:Yiqi Jieyu Granules + Real-World Treatment
Control Group 2:Placebo plus real-world treatment

Sponsors

Nanjing Neurological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: a. Meets the Western medical diagnostic criteria for depression; conforms to the Chinese medicine diagnostic criteria for qi stagnation or qi deficiency. b. Stable vital signs; normal cognitive ability, language communication, and expression. c. Age between 18 and 80 years, gender (unrestricted). d. Voluntarily participates in this trial, willing to comply with the treatment, and signs the informed consent form.

Exclusion criteria

Exclusion criteria: a. Severe primary diseases of the liver, kidney, heart, brain, or other systems; b. Pregnant or breastfeeding women; c. Organic mental disorders and depression or epilepsy caused by psychoactive substances or non-addictive substances; d. History of neurotic or mental diseases, suicidal tendencies, and deemed ineligible for inclusion by the investigator; e. Currently participating in other clinical trial projects; f. Currently using traditional Chinese medicine formulations or acupuncture and other non-drug therapies of traditional Chinese medicine outside of the study drugs.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale-17;

Secondary

MeasureTime frame
HAMA;Patient Health Questionnaire-9;Patient Health Questionnaire-15;Somatization Symptom Self-Rating Scale;The World Health Organization Quality of Life Assessment Scale (WHOQOL-BREF);Short Form 36 Health Survey;Efficacy Index;Efficient;Depression and Qi stagnation in Traditional Chinese Medicine;Qi Deficiency Syndrome Evaluation Scale;Integrated Traditional Chinese and Western Medicine Treatment Satisfaction Scale;

Countries

China

Contacts

Public ContactQiao Huifen

Nanjing Neurological Hospital

huifenaqiao@163.com13951771613

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026