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

January 11, 2017 updated by: Dr. Willmar Schwabe GmbH & Co. KG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom
        • Cardiff University, Common Cold Centre, Cardiff School of Biosciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: EPs® 7630

Active Comparator 20 mg EPs® 7630 film-coated tablet

  • During the common cold free period: One film-coated tablet (20 mg) three times a day
  • During a common cold episode: Two film-coated tablets (1 x 20 mg and 1x placebo) three times a day (in the morning, midday and evening; total daily dose 60 mg) over the individual treatment duration of 14 consecutive days.
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)
Other Names:
  • Pelargonium root liquid extract, dried
Drug: Placebo
Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)
Active Comparator: EPs(R) 7630

Active Comparator 20 mg EPs® 7630 film-coated tablet

  • During the common cold free period: One film-coated tablet (20 mg) three times a day
  • During a common cold episode: Two film-coated tablets (2 x 20 mg = 40 mg) three times a day (in the morning, midday and evening; total daily dose 120 mg) over the individual treatment duration of 14 consecutive days.
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)
Other Names:
  • Pelargonium root liquid extract, dried
Placebo Comparator: Placebo
  • During the common cold free period: One film-coated tablet (placebo) three times a day
  • During a common cold episode: Two film-coated tablet (placebo) three times a day (in the morning, midday and evening) over the individual treatment duration of 14 consecutive days.
Drug: Placebo
Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurrence of Adverse Drug Reactions (ADRs)
Time Frame: during the 4 months treatment
during the 4 months treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse Events (AEs) during the 4 months treatment
Time Frame: Adverse events will be documented during the 4 months treatment period.
Adverse events will be documented during the 4 months treatment period.
Protective effects
Time Frame: Protective effects will be evaluated during the 4 months treatment period.
Time to onset of first common cold symptoms, time between last common cold episode prior to trial entry and first cold episode during the trial, total number of common cold episodes, total number of participants with at least one / more than one common cold episode
Protective effects will be evaluated during the 4 months treatment period.
Effects during a cold episode
Time Frame: Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom
Mean cold episode duration (in days), cumulative episode days, number of co-medicated cold episodes, number of patients with respiratory complications due to common cold, development of the total cold symptom score and of single symptoms during a cold episode
Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Willmar Schwabe GmbH & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moutaz SM Jawad, M.B., B.Ch., FRCP, Common Cold Centre, Cardiff School of Biosciences, Cardiff University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 701079.01.013
  • 2013-004977-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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