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Clinical Trial on Herbal Treatment of Primary Insomnia - a randomized placebo-controlled study

Clinical Trial on Herbal Treatment of Primary Insomnia - a randomized placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000668
Enrollment
Unknown
Registered
2005-10-12
Start date
2006-01-01
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

Primary insomnia

Interventions

Two groups:A Chinese herbal formula 4 weeks versus Placebo

Sponsors

Hong Kong Consortium for Globalization of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Chinese aged 18-65; 2. Meet the diagnosis of primary insomnia

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Participation in other clinical trial within 30 days of the first visit; 2. With severe incapacitating medical illnesses, recent CVA, myocardinal infarction within 6 months; 3. Any psychiatric disorders; 4. Pregnancy; 5. Intake of any benzodiazepines or other psychotropics during the 2 weeks period prior to entry; 6. Current treatment with Chinese herbal medication; 7. Any disease state which, judged by the investigator, could interfere with study evaluation

Design outcomes

Primary

MeasureTime frame
Subjective sleep recording (sleep log, fatigue questionnaire, sleep symptoms), Objective measurement (Actiwatch, polysomnography);—

Secondary

MeasureTime frame
Clinical global impression, psychiatric assessment (SCID, HADS, BDI);—

Countries

China

Contacts

Public ContactMandy Yu
mandyyu@cuhk.edu.hk+852 2636-7593

Outcome results

None listed

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