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

NCT01459952 | Completed Phase 3

• 1 other identifier: HV 02/11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Flu; Common Cold

Keywords

occurences of flu; occurences of common cold

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Quality of life

  6 months

• Sleep quality

  6 months

• Pain in muscles and joints

  6 months

• Stiffness in muscles and joints

  6 months

• Body weight

  6 months

Study Arms (2)

Rose hip Liquid

EXPERIMENTAL

20 ml Rose hip Liquid BID

Dietary Supplement: Rose hip Liquid

Placebo

PLACEBO COMPARATOR

20 ml placebo liquid BID

Dietary Supplement: Rose hip Liquid

Interventions

Rose hip Liquid DIETARY_SUPPLEMENT

Rose hip Liquid, 20 ml BID

Placebo; Rose hip Liquid

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyben Vital ApS: lead

Study Sites (1)

Frederiksberg University Hospital

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Influenza, Human; Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections

Study Officials

• Kaj Winther, Dr

  Department of clinical biochemical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 26, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

DK (1)