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Clinical Study on the therapeutic delay of Acupuncture in Improving Medication Response in Young Adults with Moderate Anxiety with Insomnia

Clinical Study on the therapeutic delay of Acupuncture in Improving Medication Response in Young Adults with Moderate Anxiety with Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001380
Enrollment
Unknown
Registered
2025-07-11
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Generalized anxiety disorder

Interventions

positive control group:sertraline or escitalopram oxalate tablets
experimental group:Acupuncture combined with sertraline or escitalopram oxalate tablets
Placebo control group:Sham acupuncture combined with sertraline or escitalopram oxalate tablets

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 44 Years

Inclusion criteria

Inclusion criteria: 1)Meet diagnostic criteria for Generalized Anxiety Disorder (GAD) and Insomnia Disorder according to both Traditional Chinese Medicine (TCM) and Western medicine standards. 2)Aged 18-44 years both genders eligible. 3)Baseline scores meeting: GAD-7 (Generalized Anxiety Disorder-7): 10-14 points ISI (Insomnia Severity Index): =8 but 5 but <16 points 4)Voluntarily participate in the study by signing informed consent and able to adhere to acupuncture therapy and/or Western medication protocols.

Exclusion criteria

Exclusion criteria: 1)Pregnant or lactating women. 2)Patients diagnosed with: Mild or severe generalized anxiety disorder (GAD-7 3×ULN eGFR <30 mL/min) Malignancies Hematologic disorders Cardiovascular/cerebrovascular diseases (e.g. NYHA Class III/IV heart failure recent stroke). 5)Hypersensitivity or intolerance to: Escitalopram oxalate (or its excipients) Sertraline (or its excipients) Acupuncture therapy. 6)Recent interventions (within 30 days prior to enrollment): Acupuncture treatment Psychotropic medications (e.g. antidepressants anxiolytics) Or failure to complete the 30-day washout period.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Rating Scale;The Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
The Insomnia Severity Index;The Asberg Side Effect Rating Scale;The Generalized Anxiety Disorder Scale;The 36-Item Short Form Health Survey;

Countries

China

Contacts

Public ContactLiu Jianhua

Guangdong Provincial Hospital of Traditional Chinese Medicine

jyhf08@sina.com13729889452

Outcome results

None listed

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