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A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of Qili Dingxuan tablets in treating dizziness caused by cervical spondylosis (liver yang hyperactivity syndrome)

A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of Qili Dingxuan tablets in treating dizziness caused by cervical spondylosis (liver yang hyperactivity syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001182
Enrollment
Unknown
Registered
2025-06-15
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Dizziness caused by cervical spondylosis

Interventions

Experimental group:Strong Dizziness Relief Tablets (6 tablets per dose, 3 times a day)
control group:Strong Dizziness Relief Tablets (6 tablets per dose 3 times a day)

Sponsors

Wangjing Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 75 years old (including 18 and 75), with no gender restrictions; meeting the diagnostic criteria for vertebral artery type cervical spondylosis according to Western medicine; meeting the diagnostic criteria for hyperactive liver yang syndrome according to Traditional Chinese Medicine; showing degenerative changes in cervical spine on X-ray examination; willing to participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Dizziness caused by extracranial, cardiac, cerebral, or ear-related conditions (such as diagnosed cases of benign paroxysmal positional vertigo, encephalitis, acute cerebral hemorrhage or infarction, intracranial tumors, trauma, atrial or ventricular fibrillation, eye diseases, etc.); 2. Neck and shoulder pain due to non-cervical disc degenerative changes, upper limb pain primarily caused by lesions outside the cervical spine, such as amyotrophic lateral sclerosis, spinal cord lesions, acute spinal cord injury, subacute combined degeneration of the spinal cord, syringomyelia, chronic multiple peripheral neuropathy, cervical infection, spinal vascular disease, spinal cord tumors, etc.; 3. Presence of spinal cord type, nerve root type cervical spondylosis, and severe osteoporosis; 4. History of spinal trauma or spinal nerve damage, presence of tumors, carotid artery stenosis, or recent trauma within the brain; 5. Hypotension; 6. Known allergy or sensitivity to any component of the test drug; 7. History of epilepsy, schizophrenia, psychosis, moderate to severe depression or anxiety, intellectual disability, etc.; 8. Renal function Scr above the normal upper limit or liver function ALT and/or AST > 1.5 times the normal upper limit; 9. Severe diseases affecting major organs or systems such as the heart, brain, liver, kidneys, or hematopoietic system; 10. Drug abuse history within six months before informed consent, or use of drugs within three months before informed consent; 11. Use of anti-dizziness medications, antihistamines, anxiolytics, corticosteroids, benzodiazepines, or other drugs that may affect efficacy evaluation (such as diphenhydramine, flunarizine, promethazine, chlorpromazine, diazepam, dexamethasone, betahistine, etc.) within two weeks before informed consent; 12. Participation in other clinical trials within three months before informed consent; 13. Pregnant or lactating women, or those with plans for pregnancy during the trial period or three months after discontinuation of the study, or refusal to use contraception during the research period; 14. Subjects deemed unsuitable by the investigator (such as critically ill patients who make it difficult to accurately evaluate the drug's efficacy and safety).

Design outcomes

Primary

MeasureTime frame
Symptoms and functional scores of cervical vertigo;

Secondary

MeasureTime frame
Symptoms and functional scores of cervical vertigo;SF-12 Health Survey Score;Disappearance Rate of Individuai Symptoms;Traditional Chinese Medicine symptom scoring;

Countries

China

Contacts

Public ContactYang Kexin

Wangjing Hospital of China Academy of Chinese Medical Sciences

13611261137@163.com010-84739194

Outcome results

None listed

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