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.

A prospective double blind, randomised, placebo-controlled 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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001199808

Enrollment

Registered

2012-11-14

Start date

2012-10-21

Completion date

2014-05-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

1. This is a double-blind, randomised, placebo-controlled study to evaluate the efficacy of a vitamin, mineral and herbal formulation. The aim is to investigate if the formulation reduces cold & flu symptoms including symptom duration compared to placebo. 2. All participants are provided with the cold/flu treatment pack – which includes the product (active treatment or placebo), a daily symptom diary and a pre-prepared QML pathology form for Influenza antigen testing. 3. If a participant experiences 2 or 3 more cold/flu symptoms during the 6 month study period (according to the Wisconsin Upper Respiratory Symptom Survey), they need to a) start treatment, b) have the antigen test taken at a local QML pathology collection centre, c) record their symptom severity in the diary every day until symptoms resolved. 4. Within 2 weeks from the cold/flu resolving, the participant is asked to attend a final interview, returning the diary and unused product. 5. There will be regular communication with all participants during the study. Once the number of cold/flu episodes reaches the quota (49 per group), all participants will be informed that the study has been completed. Therefore, it is expected that not all participants will experience a cold/flu episode while enrolled in the study.

Interventions

Treatment commences on the day that the cold/flu symptoms appear and continue for the following 10 days. The trial is completed once a subject has experienced a cold/flu episode. The Day-time capsule (1 capsule 4 times/day) Echinacea purpurea juice equiv fresh flowering herb 4g, Salix alba equiv. fresh stem bark 1.2g, Ascorbic acid (Vitamin C) 250mg, Zinc (as sulfate monohydrate), 12mg, Garlic oil (Allium sativum) equiv. fresh bulb 2.5g, Zingiber officinale equiv. dry rhizome 500mg and Glycyrrhiza glabra equiv. dry rhizome 500mg The Night-time Capsule (1 capsule each day before sleep): Valeriana officinalis equiv. dry root 2g, Echinacea purpurea juice equiv fresh flowering herb 2g, Salix alba equiv. fresh stem bark 1g, Garlic oil (Allium sativum ) 500mg and Glycyrrhiza glabara equiv. dry rhizome 500mg.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Outcome results