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RCT to Evaluate the Efficacy and Safety of Ivy Leaves Cough Liquid vs. Placebo in the Treatment of Acute Cough

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ClinicalTrials.gov Identifier: NCT02396706
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Engelhard Arzneimittel GmbH & Co.KG

Brief Summary:
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough

Condition or disease Intervention/treatment Phase
Acute Cough Drug: Ivy Leaves Cough Liquid Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of a Liquid Containing Ivy Leaves Dry Extract vs. Placebo in the Treatment of Acute Cough
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Active Comparator: Ivy Leaves Cough Liquid
Ivy Leaves Cough Liquid
Drug: Ivy Leaves Cough Liquid
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: whole treatment period over 7 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute cough with symptoms lasting 2-3 days prior to treatment
  2. Men or women of any ethnic origin
  3. Age 18 to 75 years
  4. Subjects who are able to understand and are willing to comply to trial instructions
  5. Having given written informed consent
  6. Satisfactory health except for the cough as determined by the investigator based on medical history and physical examination
  7. CS score of at least 50 mm on a 100 mm VAS at V1
  8. Acute BSS of at least 10 points at V1
  9. VCD score of at least 2 points at V1

Exclusion Criteria:

  1. Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
  2. History of hypersensitivity to any excipient of the applied drugs
  3. History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
  4. History of chronic gastritis or peptic ulcers
  5. Any gastrointestinal complaints within 7 days before V1
  6. Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly
  7. Treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ACE) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before V1
  8. Drug or alcohol abuse in the opinion of the investigator
  9. Pregnant or nursing (lactating) women
  10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception.
  11. Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject's ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease.
  12. Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396706


Locations
Germany
Medizentrum Essen-Borbeck
Essen, Germany
Sponsors and Collaborators
Engelhard Arzneimittel GmbH & Co.KG
Investigators
Principal Investigator: Axel Schaefer Medizentrum Essen-Borbeck

Responsible Party: Engelhard Arzneimittel GmbH & Co.KG
ClinicalTrials.gov Identifier: NCT02396706     History of Changes
Other Study ID Numbers: EA-14-01-077
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms