Clinical trial NCT02174653: Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides)
Official title: Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) A Prospective, Monocentric, Randomised, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: Dr. Willmar Schwabe GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.

Detailed description: 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.

Eligibility criteria: 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

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):

   * Established use of oral, injected or implanted hormonal methods of contraception
   * Placement of an intrauterine device (IUD) or intrauterine system (IUS)
   * Barrier methods of contraception: Condom and/or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
   * Sexual abstinence
   * 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, dysbacteriosis) 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

Primary outcomes:
measure: Occurrence of Adverse Drug Reactions (ADRs)
timeFrame: during the 4 months treatment
Secondary outcomes:
measure: Occurrence of Adverse Events (AEs) during the 4 months treatment
timeFrame: Adverse events will be documented during the 4 months treatment period.
measure: Protective effects
timeFrame: Protective effects will be evaluated during the 4 months treatment period.
measure: Effects during a cold episode
timeFrame: Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff University, Common Cold Centre, Cardiff School of Biosciences
state: Wales
Study officials:
affiliation: Common Cold Centre, Cardiff School of Biosciences, Cardiff University
name: Moutaz SM Jawad, M.B., B.Ch., FRCP
role: PRINCIPAL_INVESTIGATOR
References: