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Completed

NCT Number: 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

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.

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Key information

Conditions

Flu Common Cold Infections Influenza, Human Orthomyxoviridae Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Frederiksberg University Hospital

Frederiksberg, 2000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rose hip Liquid

Dietary Supplement

Rose hip Liquid, 20 ml BID

Primary outcomes

  1. Frequency and duration of colds and flu attacks

    Time frame: 6 months

    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 outcomes

  1. Quality of life

    Time frame: 6 months

    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.

  2. Sleep quality

    Time frame: 6 months

    General wellbeing concerning sleep quality. Measured by using entries in the patient diary: Baseline vs.6 months and active treatment vs. placebo treatment

  3. Pain in muscles and joints

    Time frame: 6 months

    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

  4. Stiffness in muscles and joints

    Time frame: 6 months

    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

  5. Body weight

    Time frame: 6 months

    Weight changes seen at Baseline vs.6 months and active treatment vs. placebo treatment

Sponsors and collaborators

Lead sponsor

Hyben Vital ApS

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2011
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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