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Mushroom supplement shows promise for sinusitis sufferers

NCT ID NCT07460934

Disease control Sponsor: Pleuran, s.r.o. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a dietary supplement called Imunoglukan P4H® (made from pleuran, a mushroom extract, plus vitamin C) could help people with chronic sinusitis. 85 patients over age 12 took the supplement alongside standard treatments like nasal sprays and saline rinses. Researchers tracked sinus flare-ups, infections, and antibiotic use to see if the supplement made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pleuran (Imunoglukan P4H®) with vitamin C
What this could lead to
If it works, this could offer a natural supplement to help prevent sinusitis flare-ups and reduce the need for antibiotics and nasal sprays.
What could go wrong
This is a small, completed study with only 85 participants. The supplement may not provide significant benefit over standard care alone, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

85 people

The number who actually took part.

Started

Nov 2022

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age over 12 years * signed informed consent * patients with newly diagnosed CRS without nasal polyps (meeting the criteria for the definition of CRS according to EPOS) * patients without anatomical abnormalities causing nasal obstruction (nasal septal deformity, nasal turbinate hyperplasia, tumours, craniofacial deformities) * patients able and willing to complete the questionnaires, undergo rhinoendoscopic examination, upper aerodigestive tract swabs and follow-up outpatient examinations Exclusion Criteria: * refused informed consent * inability/unwillingness to complete the questionnaire, undergo rhinoendoscopic examination, upper aerodigestive tract swabs, follow-up outpatient examinations * inability/unwillingness to use the product in accordance with the research protocol and compliance \< 75% * patients with protracted rhinosinusitis, exacerbations rhinosinusitis with the presence of an asymptomatic period * patients with CRS during conservative treatment * patients with CRS after previous surgical treatment * patients with grade 3 nasal polyps * patients with adenoid vegetations/persistent pharyngeal tonsils (especially if children are included in the study) * patients with CRS with anatomical abnormalities causing nasal obstruction (septal deformity, turbinate hyperplasia, tumors, craniofacial abnormalities) * patients with significant immunodeficiency * patients with mucociliary transport disorders (e.g. cystic fibrosis, primary ciliary dyskinesia) * patients taking other immunomodulating preparations regularly and for a long time (e.g. beta-glucans, Preventan, vitamins C and D, probiotics, Echinacea, bacterial lysates, etc.) * pregnant and breastfeeding women

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis respiratory tract infectious disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic prophylaxis Chronic rhinosinusitis (CRS) Exacerbations Respiratory tract infections (RTI)

Contacts and locations

Locations

  • Department of Pediatric ENT, University Hospital Brno - Children's Hospital, Černopolní 9, Brno, Czechia 613 00

    Brno, Czechia, 61300, Czechia

  • ORL department, F.D. Roosevelt University Hospital with Policlinic

    Banská Bystrica, Slovensko, 97517, Slovakia

  • ORL department, University Hospital Brno, Jihlavská 25

    Brno, Czechia, 62500, Czechia

  • ORL-HP s.r.o., Nemocničná - poliklinika 1

    Veľký Krtíš, Slovensko, 99001, Slovakia

  • Sante s.r.o, Zdravomed 2, Cesta k nemocnici 1

    Banská Bystrica, Slovensko, 97401, Slovakia

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