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

Hyben Vital

Status and phase

Completed

Phase 3

Conditions

Flu

Common Cold

Treatments

Dietary Supplement: Rose hip Liquid

Study type

Interventional

Funder types

Industry

Identifiers

NCT01459952

HV 02/11

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.