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Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair

NCT06384833 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-04-25

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:

Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.

Participants will:

Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests.

Conditions

  • Rotator Cuff Tears

Interventions

DRUG

Ascorbic acid

Vitamin C (solution) 500 mg IV q4h for 4 doses PO d0 Vitamin C (tablet) 100mg 5 tab PO BID for 45 days

DRUG

N-acetyl cysteine

NAC (effervescent) 600mg 1 tab PO OD for 45 days

OTHER

placebo

pharmacologically inactive substance

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-09-01
Completion
2026-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06384833 on ClinicalTrials.gov