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A clinical trial of Wei Bi Formula for treating "Wei Zheng Syndrome" cervical spondylotic myelopathy.

A clinical trial of Wei Bi Fang for treating "Wei Zheng type" cervical spondylotic myelopathy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000334
Enrollment
Unknown
Registered
2025-02-18
Start date
2024-02-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

cervical spondylotic myelopathy

Interventions

comparison group: Placebo treatment 4 sachets/dose, 2 times/day, taken orally after breakfast, lunch and dinner for 8 weeks.
treatment group:Wibi Formula 4 sachets/times 2 times/day taken orally after breakfast lunch and dinner for a treatment period of 8 weeks.

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. those who met the diagnostic criteria of western medicine; 2. Mild and moderate patients (mJOA score =12); 3. Those who are recognized as "Wibi Syndrome" in Chinese medicine; 4. Voluntary acceptance of Chinese medicine treatment; 5. Age =18 years =75 years; 6. Those who have not used other treatments within 2 weeks before the screening; 7. Those who agreed to participate in the trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with obvious concurrent evidence or comorbidities (e.g. patients with hypertension systolic blood pressure =160mmHg and diastolic blood pressure =100mmHg after taking antihypertensive drugs and diabetes mellitus fasting blood glucose =7.0mmol/L after taking hypoglycemic drugs); 2. Women who are breastfeeding pregnant or preparing for pregnancy; 3. Those with other types of cervical spondylosis such as nerve root type cervical spondylosis and vertebral artery type cervical spondylosis; 4. The sagittal diameter of the spinal canal is less than 11mm and the Pavlvo ratio is less than 0.75 (the ratio of the mid-sagittal diameter of the cervical spinal canal to the mid-sagittal diameter of the cervical vertebral body) or vertebral instability (the vertebral body sliding forward or backward by a distance of more than or equal to 3.5mm or the vertebral body angle of more than or equal to 11°) is seen; 5. MRI with T2-weighted high signal suggestive of spinal degeneration or MRI with spinal stenosis up to 1/2 or spinal cord compression up to three segments; 6. those who see positive dynamic Hoffman's sign on physical examination or atrophy of hand muscles or spasticity difficulty in walking independently or dysfunction of urination; 7. with cervical spine fracture congenital malformation of cervical vertebrae cervical spinal canal bony stenosis ossification of posterior longitudinal ligament multiple sclerosis; 8. Postoperative patients with spinal cord cervical spondylosis; 9. Allergic body and people who are allergic to many kinds of drugs; 10. patients with combined liver kidney hematopoietic system endocrine system and other serious primary diseases tumors and mental illness; 11. Those who have participated or are participating in other drug clinical trials 3 months before enrollment; The existence of other reasons that the investigator believes that it is inappropriate to enroll in this trial.

Design outcomes

Primary

MeasureTime frame
mJOA score;

Secondary

MeasureTime frame
Changes in clinical symptoms signs and points of spinal cervical spondylosis;Chinese Medicine Disease Treatment;Quality of life (using SF-36 scale) scores;Nurick score;

Countries

The People's Republic of China

Contacts

Public ContactXuejun Cui

Longhua Hospital Shanghai University of Traditional Chinese Medicine

13917715524@139.com+86 189 1776 3017

Outcome results

None listed

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