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Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP

Z

Zhejiang Provincial Tongde Hospital

Status and phase

Completed
Phase 4

Conditions

Low Back Pain

Treatments

Drug: Celecoxib
Drug: herbal compound

Study type

Interventional

Funder types

Other

Identifiers

NCT06336993
liuxianguiji

Details and patient eligibility

About

The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally.

Enrollment

71 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • a. Patients with low back pain who were seen between January 1, 2022 and June 16, 2023 were included;
  • b. meet the diagnostic criteria of NSLBP;
  • c. the age range was 20-90 years old;
  • d. agree to participate in the study and sign the informed consent;

Exclusion criteria

  • a. those who are unable to communicate normally, such as those suffering from mental and cognitive diseases, and cannot cooperate with the treatment;
  • b. pregnant or lactating women;
  • c. patients who are allergic to the treatment components or sulfonamides;
  • d. patients with a history of coronary artery bypass grafting;
  • e. patients with active gastrointestinal ulcer or bleeding;
  • f. patients with severe heart failure;
  • g. Patients with hepatic and renal insufficiency.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

71 participants in 2 patient groups

herbal compound
Experimental group
Treatment:
Drug: herbal compound
celecoxib
Active Comparator group
Treatment:
Drug: Celecoxib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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