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
Primary Purpose
Flu, Common Cold
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Rose hip Liquid
Sponsored by
About this trial
This is an interventional prevention trial for Flu focused on measuring occurences of flu, occurences of common cold
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.
Sites / Locations
- Frederiksberg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rose hip Liquid
Placebo
Arm Description
20 ml Rose hip Liquid BID
20 ml placebo liquid BID
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
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
Body weight
Weight changes seen at Baseline vs.6 months and active treatment vs. placebo treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01459952
Brief Title
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
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyben Vital ApS
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flu, Common Cold
Keywords
occurences of flu, occurences of common cold
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rose hip Liquid
Arm Type
Experimental
Arm Description
20 ml Rose hip Liquid BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 ml placebo liquid BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Rose hip Liquid
Intervention Description
Rose hip Liquid, 20 ml BID
Primary Outcome Measure Information:
Title
Frequency and duration of colds and flu attacks
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
6 months
Title
Sleep quality
Description
General wellbeing concerning sleep quality. Measured by using entries in the patient diary: Baseline vs.6 months and active treatment vs. placebo treatment
Time Frame
6 months
Title
Pain in muscles and joints
Description
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
Time Frame
6 months
Title
Stiffness in muscles and joints
Description
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
Time Frame
6 months
Title
Body weight
Description
Weight changes seen at Baseline vs.6 months and active treatment vs. placebo treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaj Winther, Dr
Organizational Affiliation
Department of clinical biochemical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frederiksberg University Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs