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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459952
• Other study ID #: HV 02/11
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2011
• Last updated: June 5, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Hyben Vital ApS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Central Scientific Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Flu

Intervention

Dietary Supplement:
• Rose hip Liquid
Rose hip Liquid, 20 ml BID

Locations

Country	Name	City	State
Denmark	Frederiksberg University Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Hyben Vital ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Body weight	Weight changes seen at Baseline vs.6 months and active treatment vs. placebo treatment	6 months	Yes