NCT02174653

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Dr. Willmar Schwabe GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	EPs® 7630	20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)
DRUG	Placebo	Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-07-01
• Completion: 2016-08-01
• First posted: 2014-06-25
• Last updated: 2017-01-12

Locations

1 site across 1 country: United Kingdom