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Efficacy and safety of Danlu Tongdu tablets on cervical spondylosis and degenerative lumbar spondylolisthesis

Efficacy and safety of Danlu Tongdu tablets on cervical spondylosis and degenerative lumbar spondylolisthesis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074560
Enrollment
Unknown
Registered
2023-08-09
Start date
2023-08-10
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Spondylosis And Degenerative lumbar spondylolisthesis

Interventions

High-dose group for cervical spondylosis:High-dose group: Danlu Tongdu tablets (Henan Lingrui Biopharmaceutical Co., Ltd., Sinopharm Z20050085), 6 tablets/time, 3 times/d. 15d?
Low-dose group for cervical spondylosis:Low-dose group: Danlu Tongdu tablets (Henan Lingrui Biopharmaceutical Co., Ltd., Sinopharm Z20050085), 3 tablets/time, 3 times/d. 15d?
Control group for cervical spondylosis:Placebo control group: oral Danlu Tongdu tablets placebo (provided by Henan Lingrui Biopharmaceutical Co., Ltd.), the same method of use Before, the course of tr
Lumbar spondylolisthesis Danlu Tongdu film group:Danlu Tongdu Group: Danlu Tongdu tablets (Henan Lingrui Biopharmaceutical Co., Ltd., Sinopharm Z20050085), 6 tablets/time, 3 times/d. 15d?
Danlu Tongdu tablets placebo control group:Placebo control group: oral Danlu Tongdu tablets placebo (provided by Henan Lingrui Biotechnology Pharmaceutical Co., Ltd.), the method of use is the same as

Sponsors

Gansu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 65 Years

Inclusion criteria

Inclusion criteria: Cervical spondylosis:(1) Meet the diagnostic criteria; (2) chronic pain in the neck that is not easily relieved, or accompanied by numbness or pain in the upper extremities (one or both sides); tendon reflexes and weakened muscle strength of the upper extremities on the affected side; Decreased sensation in the skin; (3) Cervical spinous process and para-opening 0.5 inch tenderness; intervertebral foramen squeeze test positive Sex; (4) CT or MRI examination of cervical spine showed that cervical intervertebral disc herniation may be accompanied by nerve root compression. Spondylolisthesis: (1) Low back and leg pain, intermittent claudication, may be accompanied by cauda equina nerve symptoms. (2) There is a "step" change in the middle of the back of the waist, and the straight leg elevation test is positive or negative; There are no positive signs of lower extremity ischaemia. (3) Auxiliary examination: lumbar spine X-ray examination can show abnormal curvature of the lumbar spine, degeneration or rupture of the corresponding segment of the vertebral pedicle isthmus, vertebral body displacement, and nerve compression.(4) Age 41-75 years old. (5) Voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Cervical spondylosis:(1) Protrusion greater than 1/3 of the diameter of the spinal canal, with bifecal incontinence or lower limb paralysis; (2) The protrusion is free in the lumens of the spinal canal; (3) With spinal canalStricture or spondylolisthesis; (4) Patients with cervical spondylolisthesis, osteoporosis, tuberculosis and tumors; (5) Those who withdraw midway or use drugs to affect the results;(6) Combined with severe heart, cerebrovascular, liver and kidney, hematopoietic system and endocrine system diseases; (7) Patients with mental illness or Alzheimer's disease. Spondylolisthesis: patients with surgical indications for degenerative lumbar spondylolisthesis (indications for surgery: a with radiation pain in the lower extremities b After strict systematic treatment for more than 3 months ineffective c Progressive worsening of symptoms) (2) Slippage caused by spinal infection, trauma fracture, tumor, tuberculosis, osteoporosis (3) Combined with severe heart, cerebrovascular, liver, kidney, hematopoietic system, endocrine system diseases (4) Patients with mental illness or Alzheimer's disease (5 )Patients with peptic ulcers

Design outcomes

Primary

MeasureTime frame
visual analogue scale,VAS;

Countries

China

Contacts

Public ContactZhangYanjun

Gansu Provincial Hospital of Traditional Chinese Medicine

17730565587@163.com+86 1773065587

Outcome results

None listed

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