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Analysis of Luohua Anshen oral Liquid combined with Ciying minimally invasive acupuncture in the treatment of comorbidized insomnia and sleep apnea:a randomized double-blind placebo-controlled study

Analysis of Luohua Anshen oral Liquid combined with Ciying minimally invasive acupuncture in the treatment of comorbidized insomnia and sleep apnea:a randomized double-blind placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000742
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Co-morbid insomnia and obstructive sleep apnea

Interventions

Control group:Placebo combined with Ciying minimally invasive acupuncture treatment
Experimental group:Luohua Anshen oral liquid combined with Ciying minimally invasive acupuncture treatment

Sponsors

Shanghai Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above diagnostic criteria for obstructive sleep apnea syndrome and insomnia; (2) Age 18-80 years old; (3) Did not receive standardized OSA treatment; (4) No sleeping pills have been taken and no sleeping or psychotropic drugs have been taken in the past 2 weeks; (5) Those who can independently cooperate with each scale assessment; (6) Volunteer for participating in this study and sign informed consent and agree to accept follow-up observers.

Exclusion criteria

Exclusion criteria: (1) Patients with severe upper airway anatomical abnormalities including nasal septum deviation turbinate hypertrophy nasal polyps and nasal tumors tonsil hypertrophy above degree ? pharyngeal stenosis pharyngeal tumor pharyngeal mucosa hypertrophy tongue hypertrophy posterior root of tongue fall mandibular retraction and micrognathia; (2) Patients with a history of respiratory surgery and diabetes; (3) Patients who have been taking psychotropic drugs that affect the function of the central nervous system for a long time before screening such as antidepressants anti-schizophrenia drugs sedative hypnotics etc. and have not maintained a stable dose of medication for at least 4 weeks before screening in this experiment; (4) Patients with serious diseases of cardiovascular lung liver kidney or hematopoietic system endocrine system mental disorders brain organic diseases drug abuse or visual and hearing impairment; (5) Pregnant or lactating women; (6) alcoholics or drug addicts; (7) Those who have mental and consciousness disorders and are unable to communicate; (8) Patients who are allergic to the experimental drug or the ingredients contained in this protocol; (9) Participants who are participating in clinical trials of other drugs or who have participated in clinical trials of any drug (excluding vitamins and minerals) in the month prior to screening; (10) Unable to complete for other reasons considered by the experimenter or researcher.

Design outcomes

Primary

MeasureTime frame
Minimum oxygen saturation at night;Scores of Pittsburgh Sleep Quality Index Scale ;Apnea - hypopnea index;

Secondary

MeasureTime frame
Scores of Insomnia Severity Index Scale;Scores of Epworth Sleepiness Scale;Scores of TCM symptom scale ;

Countries

China

Contacts

Public ContactSun Yanjun

Shanghai Hospital of Traditional Chinese Medicine

1915734861@qq.com16622809395

Outcome results

None listed

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