J44 T59
Conditions
Interventions
Group 1: Luvos® Healing Earth (LHE) imutox granules, Sachet, 3 x per day 6.5g p.o for 30 days.
Group 2: Placebo granules, Sachet, 3 x per day 6.5g p.o for 30 days.
Sponsors
Heilerde-Gesellschaft Luvos Just GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy subjects; smokers without manifest chronic or acute lung disease who had smoked more than 10 cigarettes per day for at least 1 year; age = 18 years and < 65 years.
Exclusion criteria
Exclusion criteria: 1. Acute or manifest chronic lung disease (e.g. COPD, asthma) 2. Acute or chronic disease, unless the subjects have concomitant diseases and/or medication (e.g. thyroid dysfunction, hypertension, diabetes), are stable with no change in medication in the last usually 2 months and for the duration of the study, and inclusion into the study is considered justified at the discretion of the investigator. 3. Excessive drug or alcohol use (with or without the presence of a corresponding dependence) in the last 12 months 4. Taking vitamin preparations (with antioxidant effect), vitamin cocktails, food supplements, iron or other mineral preparations during the past 4 weeks, which, at the discretion of the investigator, preclude inclusion in the study, 5. Acute (last 4 weeks) or chronic, systemic infectious diseases or allergies (e.g. sinusitis, bronchitis, allergic rhinitis). 6. Known allergic reactions to Healing Earth or other loess preparations. 7. Others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the clinical investigation is the increase of total antioxidant capacity of plasma in smokers after 30 days as assessed by the Total Antioxidant Capacity (TAC) test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include additional laboratory markers of antioxidant capacity and oxidative stress in blood and urine samples (8-OH-deoxyguanosine, superoxide dismutase (SOD), vitamin C, vitamin E), change in morning symptoms due to smoking (before vs. after 30 days of use), changes in quality of life as assessed by the SF12, overall subject assessment of efficacy and tolerability, safety: adverse events. | — |
Countries
Germany, Romania
Outcome results
None listed