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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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 komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Tidsramme: Baseline to week 16
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Baseline to week 16

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.
Tidsramme: 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..
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety: Occurrence of adverse events and Serious Adverse Events
Tidsramme: Baseline to week 16
Occurrence of adverse events and Serious Adverse Events
Baseline to week 16

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

RDC Clinical Pty Ltd

Samarbejdspartnere

iNova Pharmaceuticals

Efterforskere

  • Studieleder: Emily MacNaughton, iNova Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NOURTI

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forkølelse

Kliniske forsøg med Novel Herbal Cold & Flu Blend

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner