?lumbar disc herniation
Conditions
Interventions
Experimental group:TakeYishen Zhuanggu Tongluo Pills, 6.16g per dose, three times daily, for a continuous period of 6 weeks.
Control group:TakeYishen Zhuanggu Tongluo Pills Simulator, 6.16g per dose, three times daily, for a continuous period of 6 weeks.
Sponsors
Xinjiang Uygur autonomous region hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Patients aged 18-65 years, no gender restrictions. 2)Meet Western medical diagnosis criteria for lumbar disc herniation and Traditional Chinese Medicine (TCM) syndrome classification standards, with physical examination symptoms localized to the herniated disc segment. 3)No history of surgical treatment for lumbar disc herniation within the past year, and not indicated for lumbar surgery. 4)Visual Analogue Scale (VAS) score =4 and <7. 5)If previously treated with other medications for LDH (e.g., corticosteroids, NSAIDs, ion channel modulators, opioids, central muscle relaxants, Chinese patent medicines, topical agents), a washout period of at least 10 days is required. 6)Major organ function meets the following requirements: Absolute neutrophil count (NEUT) = 1.5 × 10^9/L, absolute lymphocyte count (LYMPH) = 0.8 × 10^9/L, hemoglobin (HGB) = 90 g/L, platelet count (PLT) = 100 × 10^9/L Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) = 2.5 × ULN, total bilirubin (TBIL) = 2.5 × ULN, albumin (ALB) = 30 g/L, alkaline phosphatase (ALP) = 2.5 × ULN Creatinine (Cr) = 1.5 × ULN or creatinine clearance = 60 mL/min (calculated using the Cockcroft-Gault formula) No significant abnormalities on electrocardiogram (ECG). 7)Trial participants must consistently comply with requirements, actively participate in follow-up, and undergo regular testing and evaluation at the study center throughout the trial period. 8)Voluntary participation and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with inadequate response to rigorous conservative treatment. 2) Patients with concomitant conditions that may cause lumbar spinal dysfunction, such as lumbar spinal stenosis, spinal tumors, spinal tuberculosis, fractures, or lumbar spondylolisthesis. 3) Patients exhibiting cauda equina syndrome or progressive motor nerve damage symptoms and signs. 4) Patients with any contraindications to MRI scanning (e.g., implanted cardiac pacemakers); 5) Uncontrolled systemic diseases: including cardiovascular disease (decompensated heart failure [NYHA Class III and IV], unstable angina, acute myocardial infarction), liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, hematologic disorders, gastrointestinal disorders, organ failure, diabetes, arterial/venous thrombosis, and uncontrolled hypertension. 6) History of severe allergies or highly allergic constitution. 7) Participants who have participated in or are currently participating in other clinical trials within the preceding 4 weeks. 8) Pregnant or lactating women. 9) History of neuropsychiatric disorders diagnosed per ICD-11 criteria or neuropsychiatric conditions requiring exclusion at investigator discretion, including but not limited to epilepsy, schizophrenia, dementia, and substance/alcohol-induced addictive behaviors. 10) Irreversible electrolyte imbalance. 11) Participants deemed by the investigator to have any other factors rendering them unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index (ODI) scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) scores;Roland Morris Disability Questionnaire (RMDQ) scores;Japanese Orthopaedic Association (JOA) Scores;symptom recurrence rate;The proportion of resumed work;Absorption rate of herniated nucleus pulposus;Relative signal intensity of degenerated nucleus pulposus;Relative signal intensity ratio of degenerated nucleus pulposus;Dosage of analgesic drugs;One-year surgical rate;Quality of life; | — |
Countries
China
Contacts
Public ContactHuang Yifei
Xinjiang Uygur Autonomous Region Academy of Traditional Chinese Medicine
Outcome results
None listed