Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides)

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

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.

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.

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