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RECRUITING
NCT07339631
PHASE1

Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the clinical efficacy and safety of sodium aescinate in treating low back pain (LBP) in adult participants.

Official title: The Safety and Clinical Efficacy of Sodium Aescinate: A Double-Blind, Randomized Controlled Trial for the Treatment of Low Back Pain (LBP) in Adults

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2029-09-01

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Sodium Aescinate Tablets

This intervention is an oral sodium aescinate tablets. Each tablet contains 30mg of sodium aescinate as the active ingredient. Eligible participants will take 2 tablets per dose, twice daily (bid), for a continuous 6-week treatment period. The drug is provided by Shandong Luye Pharmaceutical Co., Ltd. and is administered in a double-blind manner, with the placebo control having identical appearance, dosage form, and administration route to ensure masking. The intervention aims to improve pain, disability, and functional status in adult patients with chronic low back pain by exerting anti-inflammatory, detumescent, and microcirculation-improving effects.

DRUG

Placebo

The intervention dosage is 2 tablets (30mg/tablet) per administration, twice daily (bid), for a continuous 6-week treatment period. During the study, participants will complete follow-up visits at baseline (week 0), week 1, week 3, and week 6 for efficacy assessments (VAS, ODI, JOA, SF-36 scores) and undergo lumbar MRI scans at baseline and week 6 to measure paraspinal muscle cross-sectional area and fat infiltration rate. All adverse events experienced during the treatment period will be recorded in detail.

Locations (1)

Xjing hospital

Xi'an, Shaanxi, China