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
Drug: Ivy Leaves Cough Liquid
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Full eligibility criteria for NCT02396706
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Acute cough with symptoms lasting 2-3 days prior to treatment
Men or women of any ethnic origin
Age 18 to 75 years
Subjects who are able to understand and are willing to comply to trial instructions
Having given written informed consent
Satisfactory health except for the cough as determined by the investigator based on medical history and physical examination
CS score of at least 50 mm on a 100 mm VAS at V1
Acute BSS of at least 10 points at V1
VCD score of at least 2 points at V1
Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
History of hypersensitivity to any excipient of the applied drugs
History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
History of chronic gastritis or peptic ulcers
Any gastrointestinal complaints within 7 days before V1
Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly
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
Drug or alcohol abuse in the opinion of the investigator
Pregnant or nursing (lactating) women
Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception.
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.
Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
All locations for NCT02396706
View full eligibility
Tris trial is registered with FDA with number: NCT02396706. The sponsor of the trial is Engelhard Arzneimittel GmbH & Co.KG and it is looking for 181 volunteers for the current phase.
Official trial 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
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