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

NCT ID: NCT02174653

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EPs® 7630

Intervention Type: DRUG

20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

Placebo

Intervention Type: DRUG

Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

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.

Group Type: ACTIVE_COMPARATOR

EPs® 7630

Intervention Type: DRUG

20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

Interventions

EPs® 7630

20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

Intervention Type: DRUG

Placebo

Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

Intervention Type: DRUG

Other Intervention Names

Pelargonium root liquid extract, dried

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Willmar Schwabe GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moutaz SM Jawad, M.B., B.Ch., FRCP

Role: PRINCIPAL_INVESTIGATOR

Common Cold Centre, Cardiff School of Biosciences, Cardiff University

Locations

Cardiff University, Common Cold Centre, Cardiff School of Biosciences

Cardiff, Wales, United Kingdom

Countries

United Kingdom

Other Identifiers

2013-004977-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

701079.01.013

Identifier Type: -

Identifier Source: org_study_id