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Clinical efficacy and mechanism of Xiaoyao San-partitioned moxibustion at navel on subthreshold depression

Clinical efficacy and mechanism of Xiaoyao San-partitioned moxibustion at navel on subthreshold depression

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085846
Enrollment
Unknown
Registered
2024-06-19
Start date
2024-06-11
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

subthreshold depression

Interventions

Part 1: Subthreshold depression group::not treated
Part 1: Healthy control group:not treated
Part 2: Observation Group:Xiaoyao San-partitional Moxibustion on Navel
Part 2: Control Group:Placebo moxibustion

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Part1: Subthreshold depression group: (1) aged 18-75 years; (2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for SD: at least two depressive symptoms persisting for no less than two weeks but not meeting the criteria for major depression; (3) Center for Epidemiologic Studies Depression Scale (CES-D) score =16; (4) right-handed. Healthy control group (1)There is no evidence of clinical psychological disorders based on a history of mental health and clinical interviews; (2) Epidemiological Research Center Depression Scale (CES-D) <16; (3) Not suffering from any disease (excluding psychological disorders) that meets the clinical diagnostic level; (4) Age range from 18 to 75 years old; (5) Right handedness. Part2: (1) aged 18-75 years; (2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for SD: at least two depressive symptoms persisting for no less than two weeks but not meeting the criteria for major depression; (3) Center for Epidemiologic Studies Depression Scale (CES-D) score =16; (4) no intervention received within one month prior to enrollment; (5) right-handed.

Exclusion criteria

Exclusion criteria: Part1: Subthreshold depression group: (1)those who have/had any mental disorder other than SD; (2) those who have/had severe suicidal tendencies, previous suicide attempts, or a history of suicide; (3) those who have/had current drug or alcohol dependence. Part2: (1)those who have/had any mental disorder other than SD; (2) those who have/had severe suicidal tendencies, previous suicide attempts, or a history of suicide; (3) those who are pregnant or during lactation, or women planning pregnancy; (4) those who have/had medically significant conditions rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure, etc.); (5) individuals with unstable work or living environments who are likely to be lost to follow-up; (6) those who have/had current drug or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
Part 1: Attention bias;

Secondary

MeasureTime frame
Part 2: Center for Epidemiologic Studies Depression Scale;Part 2: Ruminative Response Scale;Part 2: Brief Version of Connor-Davidson Resilience Scale;Part 2: Regulatory Emotional Self-Efficacy;Part 2: Pittsburgh Sleep Quality Index;Part 2: Quality of Life Enjoyment and Satisfaction Questionnaire-short form;Part 2: Attention bias;

Countries

China

Contacts

Public ContactLiu Feilai

The First Affiliated Hospital of Henan University of Chinese Medicine

feilai851211@163.com+86 189 3711 1624

Outcome results

None listed

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