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Evaluation of N-acetylcysteine in treatment of chronic hemodialysis patients

Evaluation of N-acetylcysteine in reduction of serum total oxidative stress in comparison with placebo in chronic hemodialysis patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201201108679N1
Enrollment
40
Registered
2013-05-17
Start date
2013-01-04
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Hemodialysis patients. Condition 2: Hemodialysis patients. Condition 3: Hemodialysis patients. Renal failure Renal failure Renal failure

Interventions

Intervention 1: Control Group: Placebo as 600 milligram tablet, twice daily, every 12 hours, per oral for 6 weeks, made from micro-crystalline cellulose, lactose, corn starch, sorbitol, talk (2% of to
Placebo
Treatment - Drugs
Control Group: Placebo as 600 milligram tablet, twice daily, every 12 hours, per oral for 6 weeks, made from micro-crystalline cellulose, lactose, corn starch, sorbitol, talk (2% of total tablet weigh
Intervention Group: N-acetylcysteine with trade name A.C.C, as 600 milligram tablet, made by Hexal company, given twice daily (every 12 hours), per oral for 6 weeks.

Sponsors

Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all of the chronic hemodialysis patients due to end stage renal disease more than 18 years old and at least three months has been past from starting of hemodialysis. Exclusion criteria: 1) Every acute disease leads to hospitalization from one month before trial 2) Allergy to N-acetylcysteine 3) Hepatic cirrhosis 4) Using vitamin E or C or every known antioxidant from 2 weeks before until 2 weeks after treatment with N-acetylcysteine 5) Congestive heart failure or ejection fraction less than 35% 6) Non using of N-acetylcysteine or placebo more than 20% of total drug 7) Normal basal serum total oxidative stress level.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum Level of Total Oxidative Stress. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: With ELISA method, micromol/liter with (T.A.C) Kit made by Glory company.

Secondary

MeasureTime frame
Urticaria. Timepoint: before intervention and 6 weeks after intervention. Method of measurement: Visual.;Itching. Timepoint: before intervention and 6 weeks after intervention. Method of measurement: Visual.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShokouh Shayanpour

Ahvaz Jondishapour University of Medical Sciences

dr.shayanpour@yahoo.com; shayanpour.sh@ajums.ac.ir+98 61 1374 3013

Outcome results

None listed

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