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A randomized parallel controlled non-inferiority clinical study on ShenXie Zhitong Capsule in the treatment of chronic nonspecific low back pain

A randomized parallel controlled non-inferiority clinical study on ShenXie Zhitong Capsule in the treatment of chronic nonspecific low back pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000520
Enrollment
Unknown
Registered
2024-10-09
Start date
2024-04-10
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Chronic nonspecific low back pain

Interventions

Intervention group:ShenXie Zhitong Capsule
control group:Flurbiprofen patch

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1) Age 18-70 years old male or female; 2) Patients who meet the diagnosis of non-specific low back pain; 3) Patients who exclude specific LBP before treatment; 4) ODI dysfunction score higher than 12% before treatment; 5) VAS visual pain simulation score higher than 30 points and lower than 70 points before treatment; 6) Voluntary participation in this trial and signing of informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients with severe primary diseases such as cardiovascular liver kidney and hematopoietic system; 2) Patients with clear allergies to the test drugs or with a history of drug allergies; 3) Patients with mental illness or Alzheimer's disease; 4) Pregnant and lactating women with positive urine HCG; 5) Patients who do not cooperate with treatment and do not take medication as prescribed; 6) Patients who are receiving other treatments.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index;

Secondary

MeasureTime frame
Japanese Orthopaedic Association Disability Index;Visual Analogu Scale;Range of Motion;

Countries

China

Contacts

Public ContactWang Xiang

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

w8x@163.com13816985219

Outcome results

None listed

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