Effect of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) on Viscosity and Amount of Sputum and Time to Extubation in Mechanically Ventilated ICU Patients.
|ClinicalTrials.gov Identifier: NCT00473473|
Recruitment Status : Unknown
Verified February 2012 by Menachem Oberbaum, Shaare Zedek Medical Center.
Recruitment status was: Recruiting
First Posted : May 15, 2007
Last Update Posted : February 22, 2012
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 or disease||Intervention/treatment||Phase|
|Mechanical Ventilation||Drug: Potassium Dichromate (Homeopathy) Drug: Placebo homeopathic remedy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Drug: Potassium Dichromate (Homeopathy)
twice daily with an interval of 12 hours, for a period of up to 14 days
Placebo Comparator: 2
Drug: Placebo homeopathic remedy
identical to treatment without active component
- the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation with a respirator two days after the initiation of the study. [ Time Frame: 14 days ]
- grade 3 tracheal secretions, number of suctionings and sputum neutrophil count on day 2; tracheal secretions on day 14/extubation; time to extubation and need for re-intubation; time to discharge; safety of of Kali bichromicums after 14 days/extubation. [ Time Frame: 14 days ]
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): NCT00473473
|Contact: Menachem Oberbaum, M.D.||firstname.lastname@example.org|
|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|
|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|