Clinical trial NCT01459952: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Flu
Common Cold
Keywords: occurences of flu
occurences of common cold
Lead sponsor: Hyben Vital ApS
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and duration of colds and flu attacks
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 6 months
measure: Sleep quality
timeFrame: 6 months
measure: Pain in muscles and joints
timeFrame: 6 months
measure: Stiffness in muscles and joints
timeFrame: 6 months
measure: Body weight
timeFrame: 6 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg University Hospital
Study officials:
affiliation: Department of clinical biochemical
name: Kaj Winther, Dr
role: PRINCIPAL_INVESTIGATOR
References: