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Clinical efficacy evaluation and mechanism study of Ningxin Tiaoshen acupuncture in treating primary insomnia of phlegm-heat syndrome

Clinical efficacy evaluation and mechanism study of Ningxin Tiaoshen acupuncture in treating primary insomnia of phlegm-heat syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081890
Enrollment
Unknown
Registered
2024-03-14
Start date
2024-04-23
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Phlegm-heat syndrome primary insomnia

Interventions

Experimental group:Ningxin Tiaoshen acupuncture+ Esazolam tablets+ Lifestyle guiding+ Emotional relief
Control group:Sham needling+ Esazolam tablets+ Lifestyle guiding+ Emotional relief

Sponsors

Shenzhen Hospital of Beijing University of Chinese Medicine (Longgang)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. In line with traditional Chinese and western medicine phlegm-heat syndrome insomnia diagnostic criteria; 2. Between 30 and 50 years of age; 3. The woman is not in perimenopause; 4. Pittsburgh Sleep Quality Index (PSQI) =8 points; 5. No Chinese or Western medicines, such as antibiotics, glucocorticoids, immunosuppressants, traditional Chinese medicines, or probiotics and other micro-ecological preparations, were taken at least 1month before entering the study; 6. At least 1 week before entering the study did not take sleep medication, anti-anxiety, antidepressant drugs; 7. Patients sign informed consent to participate in the study voluntarily.;

Exclusion criteria

Exclusion criteria: 1. Less than 30 years old or more than 50 years old; 2. Female patients in perimenopause; 3. Suffering from serious heart, liver, kidney, brain, nervous system diseases; 4. Obvious history of head trauma; 5. Alcohol, psychotropic drug abuse and dependence; 6. Organic lesions in gastroenteroscopy; 7. Pregnant and lactating women; 8. People who are allergic to metal contact such as needles and tools and are not suitable for acupuncture treatment; 9. Insomnia patients in special periods caused by work shifts, time difference adjustment, and recent major changes in family members; 10.The patient is participating in other medical trials;

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Self-Rating Scale of Sleep;Self-Rating Anxiety Scale;Self-rating depression scale;Treatment Emergent Symptom Scale;

Countries

China

Contacts

Public ContactLi Boling

Shenzhen Hospital of Beijing University of Chinese Medicine (Longgang)

emilyruochu@163.com+86 18811574269

Outcome results

None listed

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