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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain

NCT07058376

Chronic Low-back Pain (cLBP)

ENROLLING_BY_INVITATION NA

The Efficacy and Safety of Herbal Medicine Treatment for Obese Patients With Spinal and Joint Pain

NCT06859697

Obesity and Overweight

ENROLLING_BY_INVITATION NA

Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -

NCT03132974

Chronic Low Back Pain

UNKNOWN PHASE2/PHASE3

Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain

NCT02988232

Low Back Pain Workplace

COMPLETED PHASE4

Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

NCT00755326

Osteoarthritis of the Knee

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

herbal compound

Group Type EXPERIMENTAL

herbal compound

Intervention Type DRUG

patients were instructed to take the herbal compound twice a day for 3 weeks, 200 to 300ml each time, composition of herbal compound of BSTL was BaiShao 9g, ChuanNiuXi 15g, DanShen 15g, DiLong 9g, DuHuo 9g, DuZhong 15g, GouJi 15g, QinJiao 9g, SangJiSheng 15g, XiXianCao 9g, XuChangQin 9g and YanHuSuo 9g, and herbs were provided by the Traditional Chinese Medicine pharmacy of Tongde Hospital in Zhejiang Province.

celecoxib

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Celecoxib (Ouyi Pharmaceutical Co., LTD., H20203296) was used twice a day for 3 weeks, 200mg/ time, to treat NSLBP;

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

herbal compound

patients were instructed to take the herbal compound twice a day for 3 weeks, 200 to 300ml each time, composition of herbal compound of BSTL was BaiShao 9g, ChuanNiuXi 15g, DanShen 15g, DiLong 9g, DuHuo 9g, DuZhong 15g, GouJi 15g, QinJiao 9g, SangJiSheng 15g, XiXianCao 9g, XuChangQin 9g and YanHuSuo 9g, and herbs were provided by the Traditional Chinese Medicine pharmacy of Tongde Hospital in Zhejiang Province.

Intervention Type DRUG

Celecoxib

Celecoxib (Ouyi Pharmaceutical Co., LTD., H20203296) was used twice a day for 3 weeks, 200mg/ time, to treat NSLBP;

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No