Intervertebral disc degeneration
Conditions
Interventions
Treatment group.:Oral Bushen Huoxue recipe
Group A (control population group):none
Group B (moderate IVDD group):none
Group C (severe IVDD group):none
Sponsors
Wangjing Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria for Group A:(corresponding to parts I and II of the study) 1)Intervertebral disc degeneration MRI grading as Grade I; 2)Gender unrestricted, age between 18 to 65 years; 3)No use of drugs or treatment measures related to lumbar disc herniation within two weeks prior to treatment; 4)No history of severe heart, liver, kidney diseases, or psychiatric disorders; 5)Voluntary participation in this clinical study and agreement to sign the informed consent. 2.Inclusion criteria for Groups B and C:(corresponding to parts I and II of the study) 1)Intervertebral disc degeneration MRI grading as Grade II or higher; 2)Gender unrestricted, age between 18 to 65 years; 3)No use of drugs or treatment measures related to lumbar disc herniation within two weeks prior to treatment; 4)No history of severe heart, liver, kidney diseases, or psychiatric disorders; 5)Voluntary participation in this clinical study and agreement to sign the informed consent. 3.Inclusion criteria for Bushen Huoxue recipe treatment group.(corresponding to partsIII of the study) 1)Meet the Western medicine diagnostic criteria for DLDH, with lumbar disc herniation graded as I-II and disc degeneration graded as II-III; 2)According to Traditional Chinese Medicine's four diagnostic methods, fit the syndrome differentiation of Kidney Deficiency and Blood Stasis; 3)Gender unrestricted, aged between 18 to 65 years; 4)No use of drugs or treatment measures related to lumbar disc herniation within two weeks prior to treatment; 5)No history of serious diseases of the heart, liver, kidneys, or psychiatric disorders; 6)Voluntarily participate in this clinical study and agree to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria for Group A,B,C(corresponding to parts I and II of the study) 1)Pregnant or lactating women; 2)Patients with concomitant cauda equina syndrome or conus medullaris syndrome; 3)Patients with lumbar spine tumors, tuberculosis, or ankylosing spondylitis; 4)Patients with severe conditions such as refractory hypertension, heart disease, other severe primary diseases, or psychiatric disorders. 2.Exclusion criteria for Bushen Huoxue recipe treatment group.(corresponding to partsIII of the study) 1)Do not meet the diagnostic criteria for DLDH; 2)Patients with indications for surgery or recurrent lumbar disc herniation after surgery; 3)Pregnant or breastfeeding women; 4)Patients with concomitant cauda equina syndrome or conus medullaris syndrome; 5)Patients with lumbar spine tumors, tuberculosis, or ankylosing spondylitis; 6)Patients whose evaluation of lumbosacral pain is affected by other chronic pain conditions such as migraine or angina; 7)Patients with severe diseases such as refractory hypertension, heart disease, other serious primary diseases, or psychiatric disorders; 8)Patients allergic to the drugs used in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japanese Orthopaedic Association (JOA) score for lumbar treatment;Radiological diagnosis;Visual analog grading (VAS) scores;General indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| PRO Score;Traditional Chinese Medicine Syndrome Quantification Score.;Efficacy assessment; | — |
Countries
China
Contacts
Public ContactChen Yang
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed