Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP (NCT06336993) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP
China71 participantsStarted 2022-01-01
Plain-language summary
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.
Who can participate
Age range
20 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale
Timeframe: baseline, 1 week, 2 week, 3 week after treating
2
Oswestry disability index
Timeframe: baseline, 1 week, 2 week, 3 week after treating
3
Japanese Orthopaedic Association Scores
Timeframe: baseline, 1 week, 2 week, 3 week after treating