Acupuncture combined with Chinese medicine in the treatment of insomnia with mixed depression and anxiety disorder: A multicenter, randomized, double-blind, placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083313

Enrollment

Unknown

Registered

2024-04-22

Start date

2024-04-24

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

insomnia+ mixed depression and anxiety disorder

Interventions

A(Xuan-Yu granule + acupuncture):Xuan-Yu granules, 8g per bag, 1 bag per day, 56 bags in total. Acupuncture: Participants will receive 21 sessions of acupuncture over 8 weeks. Acupuncture will be comp

B (Xuan-Yu granule + placebo acupuncture): Xuan-Yu granules, 8g per bag, 1 bag per day, 56 bags in total. Placebo acupuncture: Acupuncture at non-acupoints will be used with blunt placebo needles of s

C (placebo Xuan-Yu granule + acupuncture):Placebo Xuan-Yu granule, 8g per bag, 1 bag per day, 56 bags in total. Acupuncture: Participants will receive 21 sessions of acupuncture over 8 weeks. Acupun

D(placebo Xuan-Yu granule + placebo acupuncture):Placebo Xuan-Yu granule, 8g per bag, 1 bag per day, 56 bags in total. Placebo acupuncture: Acupuncture at non-acupoints will be used with blunt placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Meet the diagnostic criteria for insomnia disorder in DSM-5 and the diagnostic criteria for mixed anxiety and depression disorder in ICD-11. (2)Pittsburgh Sleep Quality Index score =8 points, Insomnia Severity Index score =8 points, 17-item Hamilton Depression Rating Scale (HAMD-17) scoring 17-24 points, Hamilton Anxiety Rating Scale(HAMA) scoring 14-28 points. (3)18= age =65 years old. (4)Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Have insomnia, depression, and anxiety disorders caused by organic diseases or use of psychotropic substances; (2)Have bipolar affective disorder, schizophrenia, and/or other severe mental and sleep disorders; (3)Allergy to the drugs used in this trial; (4)Have skin damage near acupoints or is inability to receive acupuncture due to other reasons; (5)Pregnant or lactating women; (6)Participant with severe diseases such as respiratory, cardiovascular, endocrine, hematological disorders, liver or kidney dysfunction, or tumors; (7)Alcohol and drug abusers; (8)Participant who have participated in other clinical trials in the past 3 months; (9)Participant with suicidal tendencies or history of suicide attempts; (10)Other conditions unsuitable for participation in this trial.

Design outcomes

Primary

Measure	Time frame
Insomnia Severity Index scale;Hamilton Depression Scale-17;Hamilton Anxiety Scale;	—

Secondary

Measure	Time frame
Pittsburgh Sleep Quality Index;sleep diary;actigraphy;	—

Countries

China

Contacts

Public ContactWenjing Zhang

Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine

zhangwenjing@shutcm.edu.cn+86 186 1636 0246

Outcome results

None listed

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