|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN09700238 |
|
Date of registration:
|
27/06/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A randomised, placebo-controlled study of the effect of three herbal extracts (Condothymus capitatis, Origanum dictamnus and Salvia fruticosa/promifera) on the inflammatory reaction during infection of the upper respiratory tract
|
|
Scientific title:
|
A randomised, placebo-controlled study of the effect of three herbal extracts (Condothymus capitatis, Origanum dictamnus and Salvia fruticosa/promifera) on the inflammatory reaction during infection of the upper respiratory tract: an interventional, randomised, double-blind, parallel groups comparative study |
|
Date of first enrolment:
|
10/10/2013 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN09700238 |
|
Study type:
|
Interventional |
|
Study design:
|
Interventional randomised double-blind parallel groups comparative study (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Christos
Lionis |
|
Address:
|
University of Crete
Faculty of Medicine
Department of Social Medicine
2208,71003
Herakleion
Greece |
|
Telephone:
|
|
|
Email:
|
lionis@galinos.med.uoc.gr |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Adults >18 years
2. Signed and dated informed consent form
3. Capability and availability to visit one of the study centers within 24 hours of onset of URTI symptoms (common cold)
Exclusion criteria: 1. Pregnancy or lactation
2. Antibiotics use (any type and route of administration) up to 14 days prior to inclusion in the study
3. Use of antiretroviral pharmaceutical medications or herbs from Crete
4. Participation in interventional clinical study during the period of the study conduct
5. Requirement for long-term administration of aspirin, non-steroid anti-inflammatory agents or other antipyretic/analgesic medicines (such as paracetamol). Use of low dosage aspirin for the prevention of cardiovascular events is excluded
6. Use of immunosuppressive medication including the systemic administration of steroids or other cancer therapy, and/or the presence of neoplastic disease or AIDS
7. Planned surgery or other invasive procedure requiring systemic anesthesia during the period of the study conduct
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Infections and Infestations, Upper Respiratory Tract Infections
Respiratory
Upper Respiratory Tract Infection
|
|
Intervention(s)
|
1. Test product: dosage: 1 ml extract from Coridothymus capitatus + Origanum dictamnus + Salvia fruticosa/promifera dissolved in olive oil prepared in soft gel capsules.
Mode of administration: Oral
Duration of administration: 7 days
2. Placebo: dosage: olive oil, 1 ml/ in soft gel capsule
Mode of administration: Oral
Duration of administration: 7 days
|
|
Primary Outcome(s)
|
1. Recording of the severity of symptoms of upper respiratory infection in the test and in the control group with the aid of the WURSS-21 questionnaire
2. The average duration of the symptoms of URTI in the test and control groups
|
|
Secondary Outcome(s)
|
Current secondary outcome measures as of 09/07/2014
Mean change in C-reactive protein (CRP) levels from the start of administration and day 7, between the test and the control group
Previous secondary outcome measures
1. Mean change in C-reactive protein (CRP) levels from the start of administration and day 7, between the test and the control group
2. Mean change in viral load from the start of administration and day 7 between the test and the control group
Safety: the percentage of the participants that experienced an adverse event (AE) during the treatment administration period of the investigational product (7 days) will be recorded. Incidence, relatedness, severity, intensity and action taken regarding the investigational product will also be recorded.
|
|
Secondary ID(s)
|
|
2011-OLV-HERB-01
|
|
Source(s) of Monetary Support
|
|
Olvos Science SA (Greece), ref 2011-OLVOS-HERB-01
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|