Effect of the N-acetylcysteine in the inmunologycal system

N-Acetylcisteine (NAC) effect on the inmunologycal system

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001098-25-ES

Enrollment

Registered

2012-04-13

Start date

2004-08-23

Completion date

Unknown

Last updated

2022-03-21

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

Conditions

Postmenopausal health woman aged more than 50 years

Interventions

Trade Name: Fluimucil Forte Product Name: Acetylcysteine Pharmaceutical Form: Effervescent tablet INN or Proposed INN: Acetylcysteine CAS Number: 616-91-1 Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Postmenopausal women in good health more than 50 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Women with a clinical condition or relevant analytical alterations - Severe general condition - Lymphacyte Proliferation values outside of the normal range for the age - Immune diseases - Cancer - Dementia or cognitive alteration - Chronic respiratory condition - Arterial hypertension - Diabetes - Life expectancy < 1 year - Low compliance level - Continuous intake on N-acetylcysteine or vitamins or antioxidants in the previous six months

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effect of N-Acetylcysteine on the inmmunitary system principally on the Linfocyte proliferation;Secondary Objective: Evaluate the effect of N-Acetylcysteine on: - Lymphocytes: Adherence, movility, and production of IL2 - Neutrophyles:Adherence, movility, fagocytosis and superoxide anion production - NK cells: Litic capacity - Citoquines: TNF alfa production To evaluate if the effect is maintained 3 months.;Primary end point(s): ? Changes in Lymphocyte Proliferation in each group of age.;Timepoint(s) of evaluation of this end point: 4 and 7 months	—

Measure

Time frame

Main Objective: Evaluate the effect of N-Acetylcysteine on the inmmunitary system principally on the Linfocyte proliferation;Secondary Objective: Evaluate the effect of N-Acetylcysteine on: - Lymphocytes: Adherence, movility, and production of IL2 - Neutrophyles:Adherence, movility, fagocytosis and superoxide anion production - NK cells: Litic capacity - Citoquines: TNF alfa production To evaluate if the effect is maintained 3 months.;Primary end point(s): ? Changes in Lymphocyte Proliferation in each group of age.;Timepoint(s) of evaluation of this end point: 4 and 7 months

—

Secondary

Measure	Time frame
Secondary end point(s): Lymphocytes: Adherence, movility and production of IL2;Timepoint(s) of evaluation of this end point: 4 and 7 months	—

Countries

Spain

Contacts

Public ContactAntonio Esteras

Zambon, SA

antonio.esteras@zambongroup.com349354464001501

Outcome results

None listed

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