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Observation on the Efficacy of Modified Hanzheng Formula in Treating Obstructive Sleep Apnea Syndrome of Qi Deficiency and Phlegm-Stasis Type

Clinical Study of Hanzheng Formula for Moderate Obstructive Sleep Apnea Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001156
Enrollment
Unknown
Registered
2026-05-07
Start date
2022-08-02
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Obstructive sleep apnea syndrome

Interventions

Control Group:Basic treatment + Nasal Continuous Positive Airway Pressure (CPAP)
Observation Group:Basic treatment + Nasal Continuous Positive Airway Pressure (CPAP) + Modified Hanzheng Formula

Sponsors

Fangta Traditional Chinese Medicine Hospital of Songjiang District of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Western medicine diagnostic criteria and the TCM diagnostic criteria for Qi deficiency and phlegm stasis syndrome; (2) Age 35-65 years, body mass index 24-32 kg/m²; (3) Has not received nasal continuous positive airway pressure ventilation, TCM or other targeted treatments for obstructive sleep apnea syndrome within the past month; (4) Expected survival = 6 months, able to cooperate to complete 4 weeks of treatment and follow-up; (5) Voluntarily participates in this study and signs informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with central or mixed sleep apnea syndrome; (2) Patients with combined upper airway organic lesions such as nasal polyps, laryngeal cancer, etc., requiring surgical treatment; (3) Patients with severe heart failure, liver and kidney failure or coagulation disorders; (4) Patients allergic to or intolerant to nasal continuous positive airway pressure ventilation for the TCM components studied in this study; (5) Pregnant or lactating women or patients with mental illness.

Design outcomes

Primary

MeasureTime frame
Overall Clinical Effectiveness;

Secondary

MeasureTime frame
Nocturnal Polysomnography Indicators;Traditional Chinese Medicine Syndrome Score;Epworth Sleepiness Scale Score;Complete Blood Count Indicators;Adverse Reaction Rate;

Countries

China

Contacts

Public ContactZheng Yuxin

Fangta Traditional Chinese Medicine Hospital of Songjiang District of Shanghai

398697264@qq.com13816107473

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026