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A Randomized Controlled Trial of Arginine Hydrochloride Injection in the Treatment of Lumbar Intervertebral Disc Degeneration

A Randomized Controlled Trial of Arginine Hydrochloride Injection in the Treatment of Lumbar Intervertebral Disc Degeneration

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123651
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Lumbar intervertebral disc degeneration

Interventions

Experimental group (Arginine group):Intravenous infusion of arginine hydrochloride injection (initiated within 3–7 days after baseline assessment, once weekly for 4 consecutive weeks, 4 infusions in t
Control group (Placebo group):An equal volume of 1000?mL 0.9% sodium chloride injection (normal saline) was administered intravenously, initiated within 3–7 days after baseline assessment, once weekly

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with disc degenerative low back pain admitted between April 2026 and December 2026, with symptom duration >= 3 months, Visual Analogue Scale (VAS) score >= 2 in the past week, and who have signed the informed consent form. 2.Aged 18 to 65 years.

Exclusion criteria

Exclusion criteria: 1. Age under 18 or over 65 years; 2. Individuals with medical contraindications to research-use arginine; 3. Those with severe liver or kidney dysfunction, coagulation disorders, anuria, or hyperchloremic acidosis; 4. History of gastrointestinal ulcer bleeding or intracranial hemorrhage within the past 3 months, or currently taking anticoagulant medications (such as warfarin or rivaroxaban); 5. Individuals with mental illness, malignant tumors, or other severe systemic diseases who cannot tolerate interventions or follow-up; 6. Pregnant or breastfeeding women, or those planning to become pregnant during the follow-up period; 7. Other situations that, after physician assessment, are considered high-risk for medication and should be excluded.

Design outcomes

Primary

MeasureTime frame
The difference between groups in the proportion of patients showing improvement in disc imaging within 90 days of pre-treatment;

Countries

China

Contacts

Public ContactFuxin Wei

The Seventh Affiliated Hospital, Sun Yat-sen University

weifuxin@mail.sysu.edu.cn+86 135 6017 0686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026