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Not yet recruitingNCT07642648NOURTIUpdated Jun 11, 2026

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

A Phase 2 interventional study of Novel Herbal Cold & Flu Blend and Placebo in URTI and Common Cold, sponsored by RDC Clinical Pty Ltd. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by RDC Clinical Pty Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • URTI
  • Common Cold

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03

In context

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

This study's planned enrollment of 300 is above the median of 150 across 184 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

RDC Clinical Pty Ltd is the lead sponsor of 34 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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 must use a prescribed form of (e.g. oral contraceptive)

Exclusion criteria

Exclusion Criteria:

  • Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, conditions, neurological disorders such as multiple sclerosis.
  • Unstable illness e.g., changing medication/treatment.
  • \<18.5, >30
  • Current (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
  • Individuals with chronic respiratory conditions (e.g., asthma, ).
  • 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, , 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    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.

    Dietary Supplement: Novel Herbal Cold & Flu Blend

  • Placebo comparator
    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.

    Other: Placebo

Interventions

  • Dietary supplementNovel 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.

  • OtherPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system

    Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system

    Time frame: Baseline to week 16

Secondary outcomes

  1. Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.

    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.

    Time frame: Baseline to week 16

  2. Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system..

    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..

    Time frame: Baseline to week 16

  3. Number of days of absence from work / school.

    Change from baseline to the end of the Common Cold episode in Number of days of absence from work / school.

    Time frame: Baseline to week 16

  4. Perception of efficacy rated on the Treatment Satisfaction VAS.

    Change from baseline to the end of the Common Cold episode in Perception of efficacy rated on the Treatment Satisfaction VAS.

    Time frame: Baseline to week 16

  5. Safety via Adverse Event reporting and incident rate ratio between active and placebo groups

    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

    Time frame: Baseline to week 16

  6. Use of rescue medication for an URTI

    Change from baseline to the end of the Common Cold episode in Use of rescue medication for an URTI e.g. Paracetamol, Ibuprofen.

    Time frame: Baseline to week 16

Other outcomes

  1. Safety: Occurrence of adverse events and Serious Adverse Events

    Occurrence of adverse events and Serious Adverse Events

    Time frame: Baseline to week 16

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07642648
Collaborators
iNova Pharmaceuticals
Responsible party
Amanda Rao (PhD, RDC Clinical Pty Ltd) — Principal investigator
First posted
Jun 11, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 11, 2026

Study contacts

Amanda Rao
Contact
research@rdcglobal.com.au
+61(0)731024486
Emily MacNaughton
study director · iNova Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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