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A multicenter, randomized, double-blind, placebo-controlled clinical study of Jianwa Qiangji Formula for the treatment of intervertebral discogenic low back pain.

A multicenter, randomized, double-blind, placebo-controlled clinical study of Jianwa Qiangji Formula for the treatment of intervertebral discogenic low back pain.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001567
Enrollment
Unknown
Registered
2026-06-23
Start date
2025-10-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

discogenic low back pain

Interventions

Treatment group:Strengthening Waist and Spine Formula Pills
Control Group:Strengthening Waist and Spine Formula Simulated Pills

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) It conforms to the diagnostic criteria of Western medicine and the syndrome differentiation criteria of traditional Chinese medicine; 2) Age: 30 to 70 years old (including 30 and 70); 3)VAS=4 points and =7 points; 4) A lumbar MRI examination has been performed and a complete and clear MRI can be obtained. The MRI shows the presence of Modic changes. 5) Those who did not receive any therapy that would affect the results of this study within two weeks prior to the treatment; 6) Voluntarily participate in this study, be able to understand the research content and cooperate with the treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1) Low back pain caused by tumors, infections, metabolic diseases, rheumatic immune diseases, and fractures; 2) There are spinal deformities (spondylolisthesis, isthmus or scoliosis); 3) Has a history of lumbar spine surgery; 4) Suffering from neurological diseases (such as amyotrophic lateral sclerosis, Guillain-Barre syndrome, myasthenia gravis); 5) Combined with severe primary diseases of the heart, liver, kidneys, hematopoietic system, digestive system and endocrine system, etc. 6) Patients with tuberculosis and malignant tumors; 7) Those with chronic diseases such as hypertension and diabetes and whose conditions are not well controlled; 8) Patients with opioid analgesics, sedative-hypnotic drugs and mental illness; 9) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale (VAS);

Secondary

MeasureTime frame
Roland-Morris Disability Questionnaire;Multifidus muscle fat infiltration rate;Paraspinal muscle endurance;Short Form Health Survey SF-36;Traditional Chinese Medicine Clinical Efficacy Evaluation;

Countries

China

Contacts

Public ContactLi Xiaofeng

Shanghai Municipal Hospital of Traditional Chinese Medicine

lixiaofeng0409@163.com13816504131

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026