Safety and intake effect of EPs®7630 (an extract from the roots of Pelargonium sidoides)

Phase 1

Active, not recruiting

• Conditions: common cold; MedDRA version: 16.1 Level: LLT Classification code 10010106 Term: Common cold System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-004977-28-GB
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-23
• Study Completion: 2016-08-31
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 798

Inclusion Criteria

(1) Adult male or female participant (= 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 = 2 colds per year in the last 12 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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:
- 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 (> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety of a long-term (4 months) treatment with EPs®7630;<br> Secondary Objective: To analyse the health status of the participants during the study course.<br> To analyse protective effects of the IMP against common cold occurrence.<br> To analyse the effect of the IMP during a cold episode.<br> ;Primary end point(s): Occurrence of Adverse Drug Reactions (ADRs) during the 4 months treatment;Timepoint(s) of evaluation of this end point: Suspected ADRs will be documented during the whole treatment period.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): A) Occurrence of Adverse Events (AEs) during the 4 months treatment<br> B) Protective effects<br> C) Effects during a cold episode<br> ;<br> Timepoint(s) of evaluation of this end point: A) Adverse events will be documented during the whole treatment period.<br> B) Protective effects will be evaluated during the whole treatment period.<br> C) Treatment effects on cold symptoms will be documented for 14 days after onset of first cold symptom.<br>