A study on the efficacy and safety of Ruyi Zhenbao tablets for patients with lumbar disc herniatio

Not Applicable

• Conditions: umbar disc herniation; Musculoskeletal Diseases

• Registration Number: ISRCTN20449157
• Lead Sponsor: Tibet Cheezheng Tibetan Medicine Co., Ltd (china)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-30
• Last Update Posted: 9 September 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patient who meets the diagnostic criteria for lumbar disc herniation: with the guidance from the diagnostic criteria for lumbar disc herniation as outlined in the following guidelines: an evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy from the North American Spine Society (NASS, 2014), Clinical practice guideline for diagnosis and treatment of lumbar disc herniation(2020) from Chinese Orthopaedic Association of Spinal Surgery Group and Chinese Orthopaedic Association of Orthopaedic Rehabilitation Group, and the Chinese Pain Expert Consensus on the Diagnosis and Treatment of Lumbar Disc Herniation (2020). The diagnostic criteria for this study require that patients meet at least three of the first six criteria listed below, in combination with the seventh criterion (If the patient has had a CT or MRI within the past three months that provides sufficient information for a clinical diagnosis, further imaging is not required. However, if the previous imaging report is insufficient, a repeat examination is necessary). The criteria for diagnosing lumbar disc herniation are as follows:
1.1. Low back pain
1.2. Radiating pain in the lower limbs, corresponding to the distribution of the affected nerve
1.3. Sensory disturbances in the lower limbs, with decreased superficial sensation in the skin areas corresponding to the affected nerve
1.4. Positive Straight Leg Raise (SLR) test, Positive SLR enhancement test, Positive Contralateral SLR test, or Positive Femoral Nerve Stretch test
1.5. Diminished tendon reflexes compared to the healthy side
1.6. Decreased muscle strength
1.7 MRI or CT of the lumbar spine showing a herniated disc with nerve compression and symptoms and signs consistent with those of the involved nerve
2. Patients must present with symptoms of pain, numbness, or muscle tension in the lower back and/or lower limbs.
3. Patients must exhibit limited lumbar mobility, such as inability to bend forward, difficulty turning over in bed, or inability to sit for more than one hour.
4. Patient's Visual Analog Scale (VAS) score for pain: 30 mm = VAS < 70 mm
5. Oswestry Disability Index (ODI) Score: 20% < ODI = 80%
6. 18-65 years old
7. Patients must voluntarily agree to participate in the study and sign the informed consent form

Exclusion Criteria

1. Patients with combined spondylolisthesis or severe nucleus pulposus protrusion causing significant cauda equina nerve compression, or substantial and progressive loss of motor function, or those with clear surgical indications who are unsuitable for conservative treatment
2. Patients suffering from other diseases with symptoms of lower back and leg pain, such as lumbar spinal stenosis, spondyloarthritis, ankylosing spondylitis; other possible diseases include but are not limited to osteoporosis, tumors, or herpes zoster virus infection, visceral diseases (such as pelvic inflammatory disease, appendicitis, or cholecystitis), gynecological diseases, muscle or ligament strains
3. Patients allergic to the study drug or with an allergic constitution, or those with contraindications to drug use
4. Patients with severe cardiovascular, cerebrovascular, liver, kidney diseases, or severe primary systemic diseases
5. Patients with mental disorders or dementia who are unable to cooperate in completing the clinical study
6. Pregnant or breastfeeding women
7. Patients who are simultaneously participating in other clinical trial studies
8. Patients involved in litigation or legal claims

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Lower back and leg pain assessed using a Visual Analogue Scale (VAS) at baseline, and at the end of the 1st, 2nd and 4th weeks of treatment, as well as during the 2nd and 4th weeks of follow-up after the treatment concludes.<br>2. Lumbar function and symptoms evaluated using the Japanese Orthopaedic Association (JOA) score at baseline, after the 2nd and 4th weeks of treatment, and during the 2nd and 4th weeks of follow-up post-treatment.