Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster (NCT05561257) | Clinical Trial Compass
TerminatedPhase 2
Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster
Stopped: the necessary recruitment was no longer ensured and fundamental changes in the medical care of herpes zoster, which prevented the original research objectives and the feasibility of the study in the planned scope from being achieved
Germany12 participantsStarted 2020-07-20
Plain-language summary
To compare the efficacy and tolerability of three different doses of Pascorbin® besides standard medication with placebo and the reduction of herpes zoster-associated clinical symptoms as an add-on therapy for patients suffering from acute herpes zoster in primary care
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients older than 18 years
. Diagnosis of acute herpes zoster
. Presence of at least one efflorescence
. Peak NRS pain score ≥ 5 within the last 24h
. Based on the appraisal of the investigator: adequate educational as well as intelligence level and communicative capacity in order to comply with the requirements of the trial
. Written informed consent of the patient
. Negative urine pregnancy test at the baseline visit (prior to the first infusion of study medication) for female patients of childbearing potential.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean neuropathic pain
Timeframe: from Baseline to V5 (day 11-13 after baseline)
. Women of child-bearing potential must apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method (oestrogen and progestogen), or some intrauterine devices (IUDs) or sexual abstinence (true abstinence, only if in line with the preferred and usual lifestyle) or vasectomy of partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least 1 year without spontaneous menses.
Exclusion criteria
. History of oxalate-urolithiasis or nephrolithiasis
. Current active zoster episode for more than 10 days
. Known severe renal function impairment consistent with Kidney Disease Improving Global Outcome (KDIGO) Glomerular Filtration Rate (GFR) stages G4 and 5 (\< 30 ml/min/1.73m2)
. Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
. Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
. Prior vaccination with Zostavax®
. Signs or symptoms or diagnosed complications of herpes zoster such as zoster disseminatus, zoster generalisatus, zoster meningitis, zoster encephalitis, zoster myelitis, zoster pneumonitis, acute retinal necrosis (ARN)
. Contraindication to aciclovir treatment according to the current Summary of Product Characteristics (SmPC).