A study to evaluate the safety and efficacy of a complementary medicine formulation, to help relieve cold & flu symptoms and reduce duration of a cold, in otherwise healthy adults.

Phase 3

Completed

• Conditions: Treatment of the Common Cold; Treatment of Influenza; Alternative and Complementary Medicine - Herbal remedies; Infection - Other infectious diseases

• Registration Number: ACTRN12612001199808
• Lead Sponsor: A/Professor Luis Vitetta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Healthy volunteers aged between 18 and 65.

Exclusion Criteria

Not using any form of vitamin or herbal product during the trial duration.

(Females) Be pregnant or attempting to conceive.

(Females) Be breastfeeding or be lactating for at least 3 months prior to study.

Participants that have active opportunistic infections or opportunistic malignancies requiring acute treatment.

Concurrent use of any other investigational product(s).

Presence of any other acute, recurrent or chronic ear, nose, throat and respiratory tract disease than the common cold (eg bronchitis, tonsillitis, allergic rhinitis, otitis, asthma etc)

Unintended weight loss of more than 15% of body weight in last six months.

Active substance abuse (alcohol or drug dependency).

Known or suspected hypersensitivity to ingredients of the trial intervention (i.e. Soy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief of cold and influenza symptoms[Severity of symptoms to be recorded from the time the cold/flu in contracted until the episode is fully resolved, using a daily diary containing the Wisconsin Upper Respiratory Symptom Survey Daily Symptom Report]

Secondary Outcome Measures

Name	Time	Method
nil[nil]