Efficiacy and safety of Yaobitong Capsules for Lumbar Disc Herniation (syndrome of blood stasis and stagnant qi and syndrome of Venation obstruction )-a multicenter, randomized, double-blind, double-blinded clinical study
- Conditions
- umbar disc herniation
- Registration Number
- ITMCTR2200005739
- Lead Sponsor
- Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria of Western medicine;
(2) Meet the TCM syndrome differentiation standard of this disease;
(3) Age range from 18 to 60 years, male or female;
(4) 30% = patients with lumbar functional activity index (ODI) score = 80%;
(5)30mm = Patients with lower back and leg pain score = 80mm;
(6) NSAIDs anti-inflammatory and analgesic drugs and other drugs for the treatment of the disease were not used within 1 week;
(7) Informed consent and sign the informed consent form.
(1) women who are pregnant or lactating
(2) patients with allergic constitution or is allergic to this drug
(3) patients with recurrent lumbar disc herniation after operation
(4) patients with asymptomatic lumbar disc herniation or non discogenic low back pain
(5) patients with lumbar disc herniation combined with cauda equina syndrome and conus medullaris syndrome
(6) patients with lumbar disc herniation with lumbar tumor or tuberculosis, spondylolisthesis above ? 0, lumbar spinal stenosis, ankylosing spondylitis and severe osteoporosis;
(7) patients with lumbar disc herniation complicated with severe hypertension, heart disease and serious primary diseases of other organs or systems, mental patients;
(8) patients whose description of pain were affected due to acute and chronic pain in other parts of the body, such as migraine and bone and joint pain;
(9) patients who have recently received epidural closure, various interventional therapy and surgical treatment;
(10) patients who are allergy to meloxicam tablets;
(11) patients with serious primary diseases such as heart, liver and kidney (alt, AST = upper limit of normal, Cr > upper limit of normal), hematopoietic system and endocrine system, psychosis and epilepsy;
(12) patients who have participated in other clinical trials within three months;
(13) researchers who are not suitable to be selected for this experiment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Oswestry Disability Index;
- Secondary Outcome Measures
Name Time Method TCM Syndrome Integral;Visual Analogue Scale;