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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyben Vital ApS
ClinicalTrials.gov Identifier:
NCT01459952
First received: October 25, 2011
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Flu
Common Cold
 Dietary Supplement: Rose hip Liquid
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Common Cold Flu
U.S. FDA Resources

Further study details as provided by Hyben Vital ApS:

Primary Outcome Measures:
  • Frequency and duration of colds and flu attacks [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Weight changes seen at Baseline vs.6 months and active treatment vs. placebo treatment


Enrollment: 120
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459952

Locations
Denmark
Frederiksberg University Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Hyben Vital ApS
Investigators
Principal Investigator: Kaj Winther, Dr Department of clinical biochemical
  More Information

No publications provided

Responsible Party: Hyben Vital ApS
ClinicalTrials.gov Identifier: NCT01459952     History of Changes
Other Study ID Numbers: HV 02/11
Study First Received: October 25, 2011
Last Updated: June 5, 2012
Health Authority: Denmark: The Central Scientific Ethical Committee

Keywords provided by Hyben Vital ApS:
occurences of flu
occurences of common cold

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013