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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Другое 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.

Первичные конечные точки

• Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system [Срок оценки: Baseline to week 16]

Вторичные конечные точки (6)

• Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system. [Срок оценки: Baseline to week 16]
• Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system.. [Срок оценки: Baseline to week 16]
• Number of days of absence from work / school. [Срок оценки: Baseline to week 16]
• Perception of efficacy rated on the Treatment Satisfaction VAS. [Срок оценки: Baseline to week 16]
• Safety via Adverse Event reporting and incident rate ratio between active and placebo groups [Срок оценки: Baseline to week 16]
• Use of rescue medication for an URTI [Срок оценки: Baseline to week 16]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07642648 · NOURTI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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