Skip to content

Clinical Evaluation of Sub-health insomnia treated by comprehensive intervention of Traditional Chinese Medicine

Clinical Evaluation of Sub-health insomnia treated by comprehensive intervention of Traditional Chinese Medicine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001138
Enrollment
Unknown
Registered
2010-11-28
Start date
2008-05-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Sub-health insomnia

Interventions

Experimental Group:sleep hygiene instruction + balance acupuncture (insomnia points, chest pain points, shoulder pain points) + Chinese herbal drug (Bupleurum chinense and fossil fragment and shellfis
Control Group:sleep hygiene instruction + minor acupuncture (insomnia points, chest pain points, shoulder pain points) + placebo

Sponsors

The Second Hospital Affiliated to Guangzhou University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) To be diagnosed by the standard of insomnia in "Guideline on Clinical Research of Chinese Medicine Sub-health (try Line)" published by China Associetion of Chinese Medicine Sub-health Branch in December 10th, 2006 and ICD-10-CM (the Clinical Modification of the International Classification of Diseases,10th edition); (2) With age of 18-55; (3) Have a proper education backgroung: beyond Middle-school; (4) 15 marks>PSQI Score >7 marks; (5) not used of benzodiazepine, non-benzodiazepine sedative-hypnotic drugs, anti-anxiety, anti-depressive agents more than two weeks before intervention; (6) the results of routine physical examination matches existing selection criteria (see 4.4 subjects of routine physical examination); (patients with formal PE report no further than 3 months can identified accordingly, while without it, PE is required); (7) Signed an informed consent.

Exclusion criteria

Exclusion criteria: (1) Secondary insomniacs; (2) serious chronic insomniacs who is difficult to continue the normal work for failure of sleep all night long, which lasts 6 months; (3) 15 marks < PSQI Score < 7 marks; (4) SAS standard score<=59, SDS standard score<=62; (5) with the kidney, liver heart and lungs physical diseases, and the endocrine diseases (diabetes, hyperthyreosis) which are not under Control; (6) Drinking and or mental activity material and drug abuse, beside sleeping pills; (7) Serious mental mental illnesses; (8) Pregnancy or suckling period or perimenopause syndrome; (9) poor compliance; (10) have involved in another clinical trials within the past three months; (11) have accepted a proper sleep mental health guidance before Included.

Design outcomes

Secondary

MeasureTime frame
Psycho-statement;Insomnia Severity Index;Quality of Life;Objective sleep indicator;

Primary

MeasureTime frame
Pittsburge Sleep Quility Index, PSQI;

Countries

China

Contacts

Public ContactYan Li
janeliyan2002@yahoo.com.cn+86 13556054660

Outcome results

None listed

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