- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326365
Effect of Homeopathic Remedy Kalium Bichromicum on Viscosity and Amount of Sputum Mechanically Ventilated ICU Patients.
A Multicenter, Randomized, Double Blind, Placebo Controlled Trial to Investigate the Efficacy and Safety of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) to Decrease Viscosity and Amount of Sputum as Well as Time to Extubation, in Intubated Mechanically Ventilated ICU Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Profuse and tenacious tracheal secretions are a significant factor impeding the weaning process in mechanically ventilated patients in the intensive care unit (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological substances are used as remedies for the treatment of illness, which is based on the "Law of Similars" (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized, double-blind, placebo-controlled study found a statistically significant effect of this remedy on improving the amount of tracheal secretion, timing to extubation and discharge from the ICU among critically ill patients, with no side effects observed.
The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU setting. Both the quantity and viscoelasticity (measured by rheometry) of the secretions will be studied, as well as sputum neutrophil count (using direct microscopy). Time to extubation and the need for re-intubation will also be evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The preparations will be administered in the form of small pellet-like globules, which will be placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies administered twice daily with an interval of 12 hours, for a period of up to 14 days or until the patient is extubated. Any adverse event will be recorded.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Menachem Oberbaum, M.D.
- Phone Number: 972-2-6666395
- Email: oberbaum@szmc.org.il
Study Locations
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Jerusalem, Israel, 91031
- Intensive Care Unit, Shaare Zedek Medical Center
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Contact:
- Menachem Oberbaum, M.D.
- Phone Number: 972-2-6666395
- Email: oberbaum@szmc.org.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- any endotracheally intubated ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment.
- profuse tenacious, stringy tracheal secretions
Exclusion Criteria:
- Unstable septic patients
- Concomitant disease of the larynx and trachea obstructing the airway or inhibiting the extubation process.
- Patients with Tracheostomy
- Concomitant active heart disease.
- Need for catecholamines.
- Pregnancy.
- Patient with underlying neuromuscular disorder or any other condition preventing patient cooperation with voluntary coughing and expectoration of secretions.
- Patients with underlying conditions requiring continuous therapy with bronchorrheic medications (i.e. myasthenia gravis)
- Failure of the patient or legal guardian to give written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To compare efficacy of Kali bichromicum (C30) in reducing tracheal secretions in mechanically ventilated patients
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Secondary Outcome Measures
Outcome Measure |
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To compare the proportion of patients with grade 3 tracheal secretions;number of suctionings;reduction of tracheal secretions;effects on the mucus viscoelasticity and sputum neutrophil count; shortening time to extubation and need for re-intubation.
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effect in shortening the time to discharge from the ICU. To evaluate the safety of of Kali bichromicum 10-60 (C30) as compared with placebo.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Menachem Oberbaum, M.D., Shaare Zedek Medical Center, Jerusalem, Israel
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KAL.ICU.2006
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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