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Zhuang Yao Tong Luo Fang for the treatment of lumbar disc herniation: a randomized controlled trial assessing efficacy and safety.

A Randomized Controlled Trial of Zhuang Yao Tong Luo Fang for the Treatment of Lumbar Disc Herniation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000165
Enrollment
Unknown
Registered
2026-01-24
Start date
2021-04-20
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Lumbar Disc Herniation

Interventions

Treatment group:Waist-Strengthening and Luo-Connecting Formula for Oral Use
Control Group:Celecoxib Capsule orally

Sponsors

China Academy of Traditional Chinese Medicine Wangjing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.2 Diagnostic Criteria 1.2.1 diagnostic criteria: Refer to the North American Spine Society's "Guidelines for the Diagnosis and Treatment of Lumbar Disc Herniation Radiculopathy" (2013) for the development . 1) Low back pain may radiate to the buttocks and lower extremities, with sensory abnormalities in the areas innervated by the affected nerve in the lower extremities; 2) Positive straight leg raise test or; 3) Lumbar CT or MRI indicates lumbar disc herniation. 1.2.2 diagnostic criteria: Based on the "Guidelines for Clinical Research of New Traditional Chinese Medicine" [8] and the "Diagnostic and Efficacy Criteria for Traditional Chinese Medicine Diseases and Syndromes" [9], the diagnostic criteria for the TCM syndrome of liver and kidney deficiency with blood stasis obstructing the meridians were established. 1) Principal symptoms: 1) Low back pain; 2) Radiating pain in the lower extremities; 2) Secondary symptoms: 1) Weakness in the waist and knees; 2) Limited lumbar mobility; 3) Numbness in the lower extremities; 4) Fatigue while walking; 3) Tongue appearance: Pale or dark tongue with ecchymoses, scanty coating, thin white or greasy coating; 4) Pulse appearance: Deep, thready, or wiry and fine. Patients with symptoms meeting 2 principal symptoms and any 2 secondary symptoms, combined with tongue and pulse findings, can be diagnosed accordingly. 1.3 Inclusion Criteria 1) diagnostic criteria; 2) Age between 25 and 75 years; 3) Have received other conservative treatments and undergone a washout period of more than 7 days; 4) Voluntarily agree to participate as subjects and sign the informed consent form; 5) Visual Analog Scale (VAS) score between 3 and 7 points. Subjects meeting all the above conditions are eligible to be included as qualified participants in this stud

Exclusion criteria

Exclusion criteria: 1) Presence of spinal infections, tumors, tuberculosis, fractures, etc. 2) Presence of cauda equina symptoms (bowel and bladder dysfunction) or muscle weakness consistent with surgical indications. 3) Pregnant or breastfeeding women. 4) Individuals with mental disorders or other reasons for non-cooperation. 5) Severe diseases of the liver, kidneys, digestive system, cardiovascular system, or hematological system. 6) Individuals with a history of allergies or known hypersensitivity to drugs used in this trial, including sulfonamide drugs.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index scoring;

Secondary

MeasureTime frame
Visual Analogue Scale score;Japanese Orthopaedic Association Score score;

Countries

China

Contacts

Public ContactGao Chunyu

China Academy of Traditional Chinese Medicine Wangjing Hospital

870717325@qq.com18270757983

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026