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Sponsors and Collaborators: |
Shaare Zedek Medical Center Hadassah Medical Organization |
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Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00473473 |
ICU-Protocol.Summary 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 or tracheostomy and receiving controlled mechanical ventilation in the ICU setting. The quantity 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.
Condition | Intervention | Phase |
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Mechanical Ventilation |
Drug: Potassium Dichromate (Homeopathy) Drug: Placebo homeopathic remedy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 56 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
potassium bichromate
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Drug: Potassium Dichromate (Homeopathy)
twice daily with an interval of 12 hours, for a period of up to 14 days
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2: Placebo Comparator
placebo
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Drug: Placebo homeopathic remedy
identical to treatment without active component
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Menachem Oberbaum, M.D. | 972-2-6666395 | oberbaum@szmc.org.il |
Israel | |
Intensive Care Unit, Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel, 91031 | |
Dept. of Internal Medicine, Intensive Care Unit G8, Hadassah University Hospital, Ein Kerem | Recruiting |
Jerusalem, Israel | |
Contact: Sigal Svir, M.D. 972-2-6777111 |
Principal Investigator: | Menachem Oberbaum, M.D. | Shaare Zedek Medical Center, Jerusalem, Israel |
Study Director: | Moshe Hersch, M.D. | Intensive Care Unit, Shaare Zedek Medical Center, Jerusalem, Israel |
Responsible Party: | Shaare Zedek Medical Center ( Dr. Menachem Oberbaum ) |
Study ID Numbers: | KaliBic.ICU.07 |
Study First Received: | May 14, 2007 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00473473 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
homeopathy Traumeel mechanical ventilation secretions |