Efficacy of NAC for intervertebral disc degeneration.

JRCT ID: jRCTs031180436

Registered date:27/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients judged by heavy doctors to be difficult to continue
• Date of first enrollment: 10/03/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

NAC 1800mg group: Take NAC (300 mg / tablet) 2 tablets plus take 1 placebo tablet, total 3 tablets once 3 times a day for 24 weeks
NAC 2700mg group: Take NAC (300 mg / tablet) 3 tablets once 3 times a day for 24 weeks
Placebo group: Take 2 placebo tablets once 3 times a day for 24 weeks

Outcome(s)

• Primary Outcome: MRI image (T1, T2 in Q-space imaging) Initial value, change in brightness after 24 weeks
• Secondary Outcome: Pain VAS, SF-36, Pain DE-TECT Score, JOABPEQ, Amount of analgesic drug used

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

1) Patients with lumbar disc degeneration based on images(Pfirrmann grade: 3, 4) and neurological findings
2) Age From 20 years old to less than 65 years old
3) During the study period, anti-inflammatory / analgesic agents (NSAIDs including COX-2 inhibitors, an extract from Inflamed cutaneous tissue of rabbits inoculated with Vaccinia Virus (neurotropin), antioxidant vitamin E formulation(yubera), as well as steroidal agents (oral preparation and injection)), those who agree to discontinue the use.

Exclude criteria

1) Patients with complications such as severe heart, lung, liver, and blood diseases
2) Patients who received surgical treatment judged by the attending physician to affect the exam
3) Patients whose ALT / AST values before administration exceed 3 times the institution standard value
4) Currently, supplements containing NAC or NAC or supplements with antioxidant action (vitamin E) ingested
5) Patients who are allergic to drugs including NAC
6) Women who are pregnant, nursing, maybe pregnant or prefer pregnant during treatment
7) Patients who have undergone spinal surgery in the past
8) Others, patients who are judged to be unacceptable as subjects of this study by the investigator or shared medical doctor

Related Information

• Primary Sponsor: Watanabe Kota
• Source(s) of Monetary Support: AYUMI Pharmaceutical Corporation,Kanagawa Prefectural Government