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Alpha-lipoic acid combined with glucosamine hydrochloride in the treatment of early primary osteoarthritis clinical trial protocol

Alpha-lipoic acid combined with glucosamine hydrochloride in the treatment of early primary osteoarthritis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096537
Enrollment
Unknown
Registered
2025-01-24
Start date
2024-12-12
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Osteoarthritis

Interventions

control:Take placebo (1) 1g/tid+ placebo (2) 0.75g/bid at the end of 12 weeks
Experimental Group (1):Alpha-lipoic acid 1g/tid+ placebo 0.75g/bid at the end of 12 weeks
Experimental Group (2):Take glucosamine hydrochloride 0.75g/bid+ placebo 1g/tid at the end of 12 weeks
Experimental Group (3):Take alpha lipoic acid 1g/tid+ glucosamine hydrochloride 0.75g/bid at the end of 12 weeks

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Studies that met the following criteria were included: 1. Randomized controls; 2. Patients with clinically and/or radiographically diagnosed primary hip and/or knee OA; 3. Age between 40 and 80 years old, male or female; 4. Studies covering at least two of the following oral treatments: glucosamine, alpha-lipoic acid, or a combination of both versus placebo and not taking nonsteroidal anti-inflammatory analgesics or other related medications in the two weeks prior to enrollment; 5. Sign the informed consent voluntarily as the subject;

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: 1. non-randomized and/or non-controlled; 2. The treatment is not clearly described; 3. Intervention combined with non-steroidal anti-inflammatory drugs; 4. Treatment dose test group (< 1.5g/d of glucosamine hydrochloride and <3g/d of alpha lipoic acid (according to the European licensed dose); 5. Other osteoarthritis secondary to trauma, inflammation, joint instability, cumulative strain or congenital disease; 6. Patients with serious primary diseases of heart, brain, liver, kidney, lung and hematopoietic system; (7) Allergic persons, mental patients, pregnant or lactating women, those who do not want to take contraceptive measures, late deformity, disability, loss of labor force; 8. Known history of alcohol addiction or drug abuse; 9. Patients with severe metabolic diseases, etc.; 10. End-stage patients with osteoarthritis requiring joint replacement; 11. Participants who participated in other drug clinical trials within three months before enrollment.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;Lequesne Algofunctional Index;Western Ontario and McMaster Universities Osteoarthritis Index;

Countries

China

Contacts

Public ContactYingze Zhang, Tianrui Wang

The Affiliated Hospital of Qingdao University

837870382@qq.com+86 197 1053 7568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026