Plain English Summary
Background and study aims
The common cold is a mild upper respiratory illness that affects people of all ages. Symptoms include headache, sneezing, sore throat, nasal discharge (runny nose), nasal obstruction (blocked nose), cough and feeling tired. Palargonium sidoides (EPs® 7630) is an extract of a South African medicinal plant. There is evidence to suggest that it has antiviral effects and boosts the body’s ability to fight the common cold. We want to see whether taking EPs® 7630 over a 4 month period is safe and whether it can protect against, and act against, common cold infections.
Who can participate?
Adults aged at least 18 years who have experienced at least two colds in the last 12 months.
What does the trial involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given EPs® 7630 tablets for 4 months. Those in group 2 are given a placebo (dummy) tablet for 4 months. Participants in both groups take one tablet three times a day (in the morning, midday and evening) when they are not suffering from a cold. When participants in either group think they are getting a cold, they document this in a diary and take two tablets three times a day (in the morning, midday and evening) for 14 consecutive days. Each participant receives follow-up visits after 1, 2 and 3 months in order to record their state of health. After the fourth month, they come back to the study center for the final visit.
What are the possible benefits and risks of participating?
Participants may benefit from a reduction in their common cold symptoms and an improvement in their general well-being. They may also benefit from the diagnostic measures (e.g. general physical examination, laboratory test, etc.) applied at their first and last scheduled visits. During blood sampling, a small risk of infection may occur, but this can be reduced by the use of adequate techniques. It is expected that the participants will benefit from the treatment with EPs® 7630 when they suffer from symptoms of common cold during the study. As EPs® 7630 is well tolerated according to the data gathered so far, there is no major risk to taking EPs® 7630. Gastrointestinal complaints may occur during treatment with EPs® 7630, but this is not common. In rare cases, mild bleeding from the gums or nose may also occur. Hypersensitivity reactions are known to occur but are rare. There have been some reports of liver problems but a link between this and the taking of EPs® 7630 has not been proven. The further examinations are not associated with any special risk for the participants.
Where is the trial run from?
Common Cold Centre at the Cardiff University in Wales (UK)
When is the study starting and how long is it expected to run for?
March 2014 to March 2015.
Who is funding the trial?
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Who is the main contact?
F. A. Malek, M.D., Ph.D.
Fathi_Abdul.Malek@schwabe.de
Trial website
Additional identifiers
EudraCT number
2013-004977-28
ClinicalTrials.gov number
NCT02174653
Protocol/serial number
701079.01.013
Study information
Scientific title
Safety and intake effect of EPs® 7630 (an extract of the roots of Pelargonium sidoides): a randomised controlled trial
Acronym
N/A
Study hypothesis
The main objective of this clinical trial is to evaluate the safety of EPs® 7630 intake - used as continuous protection and at the onset of cold symptoms - in adult participants during a long-term (4 months) medication. Due to the sparseness of empirical data in the population and this setting, no confirmatory hypotheses are formulated and the data will be analysed descriptively.
Ethics approval
South East Wales Research Ethics Committee, Cardiff; 29/01/2014; ref. 14/WA/0015
Study design
Prospective monocentric randomised double-blind placebo-controlled parallel groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Common cold
Intervention
The trial duration per participant is four months. The participants are randomly divided into three treatment groups:
Group 1:
During the common cold free period: One film-coated tablet (20 mg) three times a day
During a common cold episode: Two film-coated tablets (1 x 20 mg and 1x placebo) three times a day (in the morning, midday and evening; total daily dose 60 mg) over the individual treatment duration of 14 consecutive days.
Group 2:
During the common cold free period: One film-coated tablet (20 mg) three times a day
During a common cold episode: Two film-coated tablets (2 x 20 mg = 40 mg) three times a day (in the morning, midday and evening; total daily dose 120 mg) over the individual treatment duration of 14 consecutive days.
Group 3:
During the common cold free period: One film-coated tablet (placebo) three times a day
During a common cold episode: Two film-coated tablet (placebo) three times a day (in the morning, midday and evening) over the individual treatment duration of 14 consecutive days.
All participants undergo following scheduled visits:
Visit 1: Day 0 (baseline)
Visit 2: 1 month ± 2 days after randomisation
Visit 3: 2 months ± 2 days after randomisation
Visit 4: 3 months ± 2 days after randomisation
Visit 5: 4 months ± 2 days after randomisation (final visit)
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Occurrence of Adverse Drug Reactions (ADRs) during the 4 months treatment.
Secondary outcome measures
1. Occurrence of Adverse Events (AEs) during the 4 months treatment
2. Protective effects
3. Effects during a cold episode
Daily documentation of AEs, common cold episodes and medication intake in participant's diary
Overall trial start date
27/03/2014
Overall trial end date
31/08/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult male or female participant (at least 18 years old)
2. Participant provided a written informed consent in accordance with the legal requirements
3. Participant with willingness and ability to comply with all procedures of the clinical trial and be available for the duration of the study
4. Participant is of good physical and mental condition
5. Participant experienced at least 2 colds per year in the last 12 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
720
Participant exclusion criteria
1. Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
2. History of heart, renal, liver, neuromuscular disease and/or immunosuppression
3. Known allergic bronchial asthma
4. Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities
5. Participant with concomitant medications that might impair the interpretation of trial results (e.g. herbal medications for common cold other than the investigational product, or pain relief medications other than Paracetamol or Ibuprofen)
6. Women of child-bearing potential with no adequate and effective contraception (MHRA, 2010):
6.1. Established use of oral, injected or implanted hormonal methods of contraception
6.2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
6.3. Barrier methods of contraception: Condom and/or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
6.4. Sexual abstinence
6.5. Vasectomised partner
7. Female participant who is pregnant, lactating or planning pregnancy during the course of the clinical trial
8. Participant with cold symptoms at inclusion
9. Current intake of antimicrobial and/or antiviral medication for any reason
10. Participant with known or suspected history of alcohol or drug abuse
11. Heavy smoking (more than 10 cigarettes per day)
12. Psychiatric disorders which may influence the results of the trial, epilepsy, or suicide attempts
13. Planned surgical intervention during the trial
(14) Known gastrointestinal disorders with uncertain absorption of orally administered medication (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, disbacteriosis) or associated with diarrhoea
15. Known or suspected hypersensitivity to the active substance or to any of the excipients of the investigational product
16. Known clinically relevant laboratory abnormalities
17. Participant with increased tendency to bleed, especially nasal or gingival bleeding
18. Previous (within the last 3 months prior to visit 1) or concomitant treatment with coagulation-inhibiting drugs such as warfarin
19. Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study
20. Previous randomisation in the present clinical study
21. Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
Recruitment start date
27/03/2014
Recruitment end date
31/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Common Cold Centre
Sir Martin Evans Building
Museum Avenue
Cardiff
CF10 3AX
United Kingdom
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
c/o F.A. Malek
M.D.
Ph.D.
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary