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Efficacy and safety of Yaobitong capsule for acute lumbar disc herniation: a protocol for a multi-center randomized controlled trial

Efficacy and safety of Yaobitong capsule for acute lumbar disc herniation: a protocol for a multi-center randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038405
Enrollment
Unknown
Registered
2020-09-22
Start date
2021-11-08
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Lumbar disc herniation

Interventions

Sponsors

Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Medical history: with or without a definite history of lumbar injury. 2.Symptoms and signs: low back pain radiates to buttocks and lower limbs, abdominal pressure increases, such as cough, sneezing, etc; There was tenderness and radiation to the lower limbs, and the lumbar movement was limited; There may be hypersensitivity or dullness in the affected innervated area of the lower limbs. Muscle atrophy may occur in patients with a long course of the disease. Tendon reflex and dorsiflexion of the toe may be weakened. 3.Physical examination: positive muscle strength and sensation test; Straight leg raising or strengthening test was a positive result. 4.Auxiliary examination: MRI showed lumbar disc herniation. 5.The patient was aged between 18 and 70 years old. The clinical symptoms were leg pain extending below the knee, which was consistent with the corresponding nerve root distribution area of the MRI. 6.The first course of low back pain or leg pain was less than 3 months, or the latest acute recurrence time was less than 3 months. 7.This study will compare the efficacy and safety of Chinese patent medicine and Western medicine in the treatment of lumbar disc herniation. 8.The VAS scores of lumbocrural pain were more than or equal to 4.0.

Exclusion criteria

Exclusion criteria: 1. The patient had a history of lumbar surgery; 2. Patients have received oral or epidural steroid therapy in recent 3 months; 3. Severe diabetes with peripheral neuropathy, severe osteoporosis, gastric ulcer, gastrointestinal bleeding, spinal tumor, spinal tuberculosis, spinal compression fracture; 4. Allergic to non-steroidal drugs; 5. There are symptoms of cauda equina nerve damage or parenchymal and progressive loss of motor function; 6. Patients with litigation or legal claims.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS);

Secondary

MeasureTime frame
Japanese Orthopaedic Association (JOA);Oswestry Disability Index (ODI);The 12-item short-form health survey (SF-12);

Countries

China

Contacts

Public ContactLeng Xiangyang

Affiliated Hospital of Changchun University of traditional Chinese Medicine

Lengxy@163.com+86 15948000708

Outcome results

None listed

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