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Safety and efficacy of Tiaoshen Tongbi granules in the treatment of non-specific low back pain

Safety and efficacy of Tiaoshen Tongbi granules in the treatment of non-specific low back pain

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088757
Enrollment
Unknown
Registered
2024-08-26
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Nonspecific low back pain

Interventions

Granule group:Tiaoshen Tongbi granules
Decoction group:Tiaoshen Tongbi formula + core function exercise
Control group:Jinwu Gutong capsule + core function exercise

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: ? Patients who meet the diagnostic criteria and TCM syndrome criteria; ? Patients who voluntarily accepted the treatment protocol of this study; ? Between the ages of 18 and 60; ?VAS score =4, =7; ? Informed consent and signed the informed consent.

Exclusion criteria

Exclusion criteria: ? Patients who do not meet the diagnostic criteria, are under 18 years of age or over 60 years of age; ? Patients who refused the treatment of this subject; ? Patients with cardiovascular and cerebrovascular diseases and mental illness, suspected to have a history of alcohol and drug abuse; (4) Patients with concomitant diseases such as fractures and bone diseases through imaging examination; ? The pain is particularly severe, accompanied by cauda equina syndrome; ? Patients who have already received other treatments that may affect the observation of therapeutic effect indicators in this study; Patients with skin diseases and infectious diseases; ? Female patients during pregnancy.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale score;(Japan Orthopaedic Association) Efficacy evaluation of low back pain disorders;Health Survey 12-item short form scores;

Secondary

MeasureTime frame
TCM syndrome score; Lumbar motion;Safety index;

Countries

China

Contacts

Public ContactMo Wen

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

mw2218@126.com+86 189 1776 3080

Outcome results

None listed

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