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Active and passive intervention conbined with characteristic treatment regimens of traditional Chinese medicine in subliminal depression: a multicentre, randomized controlled study

Research on health state intervention by active and passive ways and management techniques based on the combination of traditional Chinese medicine constitution (subtopic 3) : clinical evaluation of intervention techniques for subthreshold depression, insomnia and mild cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003218
Enrollment
Unknown
Registered
2020-04-17
Start date
2020-05-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Subthreshold depression

Interventions

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of depression under the threshold of Western medicine; Diagnosis standard of subthreshold depression: it has symptoms of depression, but fails to meet the symptom indicators required for diagnosis of depression (more than 5 of 9 items: loss of interest, no pleasure; energy loss or fatigue; psychomotor retardation or agitation; low self-evaluation, self blame, or guilt; difficulty in association or reduction of conscious thinking ability; recurrent thoughts of dying or having self Killing and self injuring behaviors; sleep disorders, such as insomnia, early wake-up, or excessive sleep; loss of appetite or weight; hyposexual desire) or course indicators (duration greater than 2 weeks). 2. The patients with CES-D score >= 16; 3. Hamilton Depression Scale (HAMD-17) score: 7 points <= HAMD total score < 17 points; 4. The patients with qi stagnation as the main constitution were classified and judged by the constitution of traditional Chinese medicine; 5. Patients aged over 18 and under 65, regardless of gender; 6. Patients who can independently complete the questionnaire, use the app, have informed consent and voluntarily fill in the questionnaire; Only those who meet the above six criteria can be selected into the research group.

Exclusion criteria

Exclusion criteria: 1. Patients with clinically confirmed depression, previous mental illness or organic mental disorder; 2. Patients with serious liver and kidney function damage, serious heart rate disorder or cardiac insufficiency; 3. Pregnancy, lactation and objects with pregnancy plan; 4. Patients with depressive episode caused by psychoactive substance and non addictive substance; 5. Patients who used other drugs or therapies to treat depression at the same time during the trial; 6. Known targets of drinking or substance dependence; 7. Patients with strong suicide attempt or behavior; 8. Patients who are participating in other clinical trials; 9. Those who fail to treat according to the specified requirements, fail to judge the curative effect or incomplete data that affect the judgment of curative effect or safety; 10. Patients who had received antidepressant treatment within one week before the trial. Those with one of the above items will not be included in the test.

Design outcomes

Primary

MeasureTime frame
CES-D;

Secondary

MeasureTime frame
HAMD;Constitution scale score;PHQ-9;

Countries

China

Contacts

Public ContactHan Zhenyun

Shenzhen Hospital of Beijing University of Chinese Medicine (Long Gang)

tohanzhenyun@sina.com+86 13581647676

Outcome results

None listed

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