A Double-blind, Randomised, Parallel Group,Comparative Study With Rose-hip Liquid and Placebo Given to Healthy Volunteers in the Winter Season Aiming to Evaluate the Occurences of Flu and Catching a Cold

A Double-blind, Randomised, Parallel Group, Phase III Comparative Study With Rose-hip Liquid and Placebo Given to Healthy Volunteers in the Winter Season Aiming to Evaluate the Occurences of Flu and Catching a Cold

The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase III study.

After the patient has receiving information about the study and after given written informed consent, the patient will be screened.

The patient's medical history and demographic information will be recorded. The patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary.

All patients are randomized to receive standardized rose hip liquid or matching placebo. The subject is instructed to take the liquid form of rose hips in the morning and evening meal. The subject will also be advised to call the clinic if there is an acute attack of cold and / or flu because they must then increase the in-take of study treatment to 3 double dose for 5 days and then return to normal dose.

The subject will then be asked a series of questions under study questionnaires, and be instructed in how questionnaires (SF-12) and diary filled. This is to provide security to the validation output values Investigator or study nurse will take telephone contact with the subject once a month, subjects will be asked about how things are going and to remember to take the liquid and whether they have completed the diary.

The last patient visit will take place after 6 months. Any side effects will be reported to and reviewed with HybenVital ApS in collaboration with medical experts.

Study Overview

• Status: Completed
• Conditions: Common Cold; Flu
• Intervention / Treatment: Dietary supplement: Rose hip Liquid

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • Frederiksberg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First Men and women aged 50 + years
• It is accepted that the subjects can be treated for medical diseases.
• It is also accepted that the subjects receiving daily medication such as diuretics and medication for Hypertension, hypercholesterolemia and blood glucose-lowering treatment, medicine that strengthens the heart, symptom-relieving medication for joint disease, etc.
• Subjects may also use n-3 fatty acids (fish oil), as long as the fixed dosage.

Exclusion Criteria:

• Subjects who have been treated with rose hip extracts or powder within 3 months before screening.
• Subjects who have been treated with ginger, avocado / soy, large doses of vitamins (including vitamin C) or other known dietary supplements within 3 months before screening
• Subjects that have been deemed to be have a hard time collaboration
• Subjects who abuse narcotics.
• Subjects who abuse alcohol
• Subjects with a current mental illness
• Subjects with known allergy to rose hips
• Subjects participating in another clinical trial, or have participated in another clinical trial within 3 months before this trial started.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rose hip Liquid; 20 ml Rose hip Liquid BID	Dietary supplement: Rose hip Liquid; Rose hip Liquid, 20 ml BID
Placebo Comparator: Placebo; 20 ml placebo liquid BID	Dietary supplement: Rose hip Liquid; Rose hip Liquid, 20 ml BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and duration of colds and flu attacks	Frequency and duration of colds and flu attacks will be analyzed within each of the two treatments (Rose hip Liquid and Placebo). The severity will also be assessed by recording the intensity of coughing, how much pain the patient has felt in the throat and if there is fever, headache and / or fatigue	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life by SF-12 will be assessed within each group in what is seen on the initial value vs. the final value at study end, and the difference between active and placebo.	6 months
Sleep quality	General wellbeing concerning sleep quality. Measured by using entries in the patient diary: Baseline vs.6 months and active treatment vs. placebo treatment	6 months
Pain in muscles and joints	General wellbeing concerning pain in muscles and joints. Measured by using entries in the patient diary: Baseline vs.6 months and active treatment vs. placebo treatment	6 months
Stiffness in muscles and joints	General wellbeing concerning stiffness in muscles and joints. Measured by using entries in the patient diary: Baseline vs.6 months and active treatment vs. placebo treatment	6 months
Body weight	Weight changes seen at Baseline vs.6 months and active treatment vs. placebo treatment	6 months

Collaborators and Investigators

• Sponsor: Hyben Vital ApS
• Investigators: Principal Investigator: Kaj Winther, Dr, Department of clinical biochemical

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: occurences of flu; occurences of common cold
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: HV 02/11