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A Novel Cold and Flu Herbal Blend for Reducing the Duration and Severity of the Common Cold (NOURTI)

7 juni 2026 uppdaterad av: Amanda Rao, RDC Clinical Pty Ltd

A Randomized Blinded Controlled Trial Evaluating the Efficacy of a Novel Herbal Cold and Flu Blend in Reducing the Duration and Severity of Symptoms of the Common Cold

The aim of this study is to evaluate the efficacy of a Novel Herbal Cold & Flu Blend in reducing the duration of symptoms of the common cold. The secondary objective is to assess whether the investigational product reduces the severity of symptoms. Participants will be enrolled for 16 weeks, during this period they will take the assigned study product when they experience URTI symptoms.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • Adults aged 18-65 years living in Australia
  • Individuals with a history of recurrent Upper Respiratory Tract infections (URTI) (at least one episode per year)
  • Able to provide informed consent
  • Generally healthy
  • Agree to not participate in another clinical trial while enrolled in this trial
  • Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
  • Females of childbearing potential must use a prescribed form of birth control (e.g. oral contraceptive)

Exclusion Criteria:

  • Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, autoimmune conditions, neurological disorders such as multiple sclerosis.
  • Unstable illness e.g., changing medication/treatment.
  • BMI <18.5, >30
  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
  • Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
  • Active smokers, nicotine use (including vaping/e-cigarettes) or drug (prescription or illegal substances) abuse
  • Current alcohol use (>21 alcoholic drinks week)
  • Allergic to any of the ingredients in the active or placebo formula
  • Allergic to plants in the Asteraceae family
  • Pregnant or lactating woman
  • Regular use of medications that would affect the immune and/or the inflammatory response e.g. antihistamines, anti-inflammatories, immunosuppressants, steroids excluding topical steroid use.
  • Use of anticoagulant medications such as warfarin.
  • Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
  • Participants with allergic rhinitis
  • Regular use of antihistamines
  • Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Novel Herbal Cold & Flu Blend
Each 485mg capsule contains the Novel Herbal Cold & Flu Blend. Participants will start taking the study product if they experience 2 or more URTI symptoms (as per the WURSS-24) or a fever above 38.0°C. Participants are to consume 2 capsules three times each day until symptoms resolve.
Kosttillskott: Novel Herbal Cold & Flu Blend
Each 485mg capsule contains the Novel Herbal Cold & Flu Blend. Participants will start taking the study product if they experience 2 or more URTI symptoms (as per the WURSS-24) or a fever above 38.0°C. Participants are to consume 2 capsules three times each day until symptoms resolve.
Placebo-jämförare: Placebo
Each placebo capsule contains Microcrystalline cellulose, Colloidal Silicon dioxide, Magnesium Stearate and Sodium Metabisulfite. Participants will start taking the study product if they experience 2 or more URTI symptoms (as per the WURSS-24) or a fever above 38.0°C. Participants are to consume 2 capsules three times each day until symptoms resolve.
Övrig: Placebo
Each placebo capsule contains Microcrystalline cellulose, Colloidal Silicon dioxide, Magnesium Stearate and Sodium Metabisulfite. Participants will start taking the study product if they experience 2 or more URTI symptoms (as per the WURSS-24) or a fever above 38.0°C. Participants are to consume 2 capsules three times each day until symptoms resolve.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Tidsram: Baseline to week 16
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Baseline to week 16

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.
Tidsram: Baseline to week 16
Change from baseline to the end of the Common Cold episode in Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.
Baseline to week 16
Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system..
Tidsram: Baseline to week 16
Change from baseline to the end of the Common Cold episode in Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system..
Baseline to week 16
Number of days of absence from work / school.
Tidsram: Baseline to week 16
Change from baseline to the end of the Common Cold episode in Number of days of absence from work / school.
Baseline to week 16
Perception of efficacy rated on the Treatment Satisfaction VAS.
Tidsram: Baseline to week 16
Change from baseline to the end of the Common Cold episode in Perception of efficacy rated on the Treatment Satisfaction VAS.
Baseline to week 16
Safety via Adverse Event reporting and incident rate ratio between active and placebo groups
Tidsram: Baseline to week 16
Change from baseline to the end of the Common Cold episode in Safety via Adverse Event reporting and incident rate ratio between active and placebo groups
Baseline to week 16
Use of rescue medication for an URTI
Tidsram: Baseline to week 16
Change from baseline to the end of the Common Cold episode in Use of rescue medication for an URTI e.g. Paracetamol, Ibuprofen.
Baseline to week 16

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Safety: Occurrence of adverse events and Serious Adverse Events
Tidsram: Baseline to week 16
Occurrence of adverse events and Serious Adverse Events
Baseline to week 16

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

RDC Clinical Pty Ltd

Samarbetspartners

iNova Pharmaceuticals

Utredare

  • Studierektor: Emily MacNaughton, iNova Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

7 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NOURTI

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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