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Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT02174653•Dr. Willmar Schwabe GmbH & Co. KG

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+16 more criteria

Locations (1)

Cardiff University, Common Cold Centre, Cardiff School of Biosciences

Cardiff, Wales, United Kingdom

Key Dates

Start Date

March 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

August 1, 2016

Last Updated

January 12, 2017

Enrollment

720

ACTUAL participants

Conditions

Common Cold

Interventions

EPs® 7630

DRUG

Placebo

DRUG

Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine

NCT06531707

Common Cold

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COMPLETEDPHASE4

A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

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Common ColdCough

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine

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