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Evaluate the Joymain far red insomnia treatment appliances improve the safety and efficacy of sleep a randomized, blank control, double blind, multi-center clinical trial

Evaluate the Joymain far red insomnia treatment appliances improve the safety and efficacy of sleep a randomized, blank control, double-blind, multi-center clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002449
Enrollment
Unknown
Registered
2012-08-16
Start date
2012-08-08
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

Insomnia

Interventions

Sponsors

First Affiliated Hospital of Henan College of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the trial, and signed informed consent; 2. ICSD "International Classification of sleep disorders" the lowest diagnostic criteria for primary insomnia (psychophysiological insomnia); 3. 7 of the Pittsburgh Sleep Quality Index factor component of accumulated points > 7 points; 4. 1 month < Course of disease <=12 month; 5. Aged 18 to 65 years of age, Outpatient cases.

Exclusion criteria

Exclusion criteria: 1. Secondary insomnia (insomnia associated with other mental disorders, sleep disorders - insomnia, substance-induced sleep disorder - insomnia type) due to medical illness, environmental sleep disorder. Sleep apnea syndrome, stroke patients, physical illness caused insomnia. Hamilton Depression Scale score >=8, Hamilton anxiety scale score >=7 points; 2. Within a week using any other drugs for treatment of insomnia; 3. Skin injury healed, bleeding tendencies, surgery or serious trauma stress situation; 4. Patients with severe hypertension [systolic blood pressure >=24KPa (180mmHg) and / or diastolic blood pressure >= 14KPa (105mmHg); 5. Implanted metal objects implanted medical electronic equipment, such as pacemakers and other persons; 6. With severe primary cardiac, liver, lung, kidney, blood, or affect the survival of serious diseases, such as cancer or AIDS; renal dysfunction; 7. Severe hypoproteinemia and serious systemic infection; 8. Mental disorders can not give fully informed consent; 9. Suspect or does have a history of alcohol and drug abuse; 10. According to the investigator's judgment, could easily lead to loss to follow to reduce the possibility of inclusion or so into the complex set of other lesions, such as working conditions change frequently; 11. Pregnancy, breast-feeding women; 12. Allergies, such as two or more drugs or a history of food allergies; or known allergy to the trial medicine; 13. Participated in other clinical trials within three months.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index, PSQ;

Secondary

MeasureTime frame
The daily sleep time improvement;Nocturnal sleep time / day awakening time;Combined with moxa division motor dose;

Countries

China

Contacts

Public ContactJacky Zhang
sqz5259@163.com+86 13666600715

Outcome results

None listed

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