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A randomized, double-blind, placebo-controlled trial for Yi-Qi Hua-Yu Tong-Sui granule in the treatment of mild or moderate cervical spondylotic myelopathy

A randomized, double-blind, placebo-controlled trial for Yi-Qi Hua-Yu Tong-Sui granule in the treatment of mild or moderate cervical spondylotic myelopathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002836
Enrollment
Unknown
Registered
2019-12-15
Start date
2020-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Mild or moderate cervical spondylotic myelopathy

Interventions

Sponsors

Department of orthopedics, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form; 2. The patients who meet the diagnostic criteria belong to mild or moderate cervical spondylotic myelopathy; 3. Male or female aged 40-75 years; 4. The course of disease is more than 3 months; 5. Volunteer to receive the treatment(Yiqi Huayu tongsui granules or placebo drugs combined with Bokebao). 6. The patients didn't received glucocorticoids orally, intravenously, intramuscularly or in soft tissue 4 weeks before accepting the test drug.

Exclusion criteria

Exclusion criteria: 1. Those who have participated in or are participating in other clinical researches in the past 3 months; 2. The patients who had been treated with regular non-surgical treatment for at least 6 months to no avail and had more severe symptoms; 3. The muscle strength decreased significantly in a short period of time, and the muscle strength was lower than grade III; 4. Patients with history of severe cervical trauma and cervical surgery; 5. Pregnant women, lactating women and psychopaths; 6. Patients with heart, liver, kidney or hematopoiesis impairment; 7. People who are allergic to various drugs; 8. Mentally or legally disabled; 9. Those who have a history of opioid analgesics, sedative hypnotics and alcohol abuse; 10. Patients with serious primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardio cerebrovascular system, nervous system, tuberculosis, vertebral deformity, malignant tumor and psychosis; 11. Those who do not read or write in Chinese.

Design outcomes

Primary

MeasureTime frame
VAS;JOA;NDI;

Secondary

MeasureTime frame
electromyogram;MRI Pfirrmann classification of cervical spine;

Contacts

Public ContactWen Mo
mowen@126.com+86 13801968271

Outcome results

None listed

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