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A randomized controlled trial protocol for the treatment of high-altitude insomnia with "White + Black" traditional Chinese medicine ointment combined with auricular point patches

A randomized controlled trial protocol for the treatment of high-altitude insomnia with "White + Black" traditional Chinese medicine ointment combined with auricular point patches

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001934
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-10-26
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

High-altitude insomnia

Interventions

White and Black Chinese Herbal Ointment Formula + Sleep Auricular Point Treatment Group:Take two traditional Chinese medicine pastes every day and one during the day (the main ingredients of the white
Sleep Auricular Point Treatment Group:Apply the sleep auricular point to one ear, select an appropriate position, and clean the selected area of the ear with 75% alcohol to remove grease. Apply it to

Sponsors

The 922nd Hospital of the Joint Logistic Support Force of the People's Liberation Army of China/ Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the diagnostic criteria for high-altitude insomnia: residing in an area with an altitude of =2000 meters for =1 month, having difficulty falling asleep (sleep latency =30 minutes), sleep maintenance disorders (awakening at night =1 time or early awakening), total sleep time < 6 hours, and the above symptoms occur =3 times a week for =1 month; (2) The total score of the Pittsburgh Sleep Quality Index (PSQI) is =8 points, and the total score of the Parsons Insomnia Scale (AIS) is =6 points. (3) Age: 18 to 65 years old, gender not limited, clear consciousness, and able to cooperate in completing the scale assessment; (4) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with severe organic diseases of the heart, liver, kidneys, or mental disorders (such as depression, anxiety); (2) Those with other sleep disorders such as sleep apnea syndrome (AHI=5 times per hour); (3) Those who have used sedative-hypnotic drugs, antipsychotic drugs or other drugs that may affect sleep within the past month; (4) Those who are allergic to the components of traditional Chinese medicine pastes; (5) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Scale;

Secondary

MeasureTime frame
Athens Insomnia Scale;Total sleep time at night;The 14-item Hamilton Anxiety Scale;Flinders fatigue scale;Epworth sleepiness score;Adverse Event;

Countries

China

Contacts

Public ContactYan Hongliang/Lv Can

The 922nd Hospital of the Joint Logistic Support Force of the People's Liberation Army of China/Naval Medical University/

jockzyk@126.com15211406620 13671710578

Outcome results

None listed

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