Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473473
Status:
UNKNOWN
Last Update Posted:
2012-02-22
First Post:
2007-05-14
Brief Title:
Effect of the Homeopathic Remedy Kalium Bichromicum Potassium Dichromate on Viscosity and Amount of Sputum and Time to Extubation in Mechanically Ventilated ICU Patients
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ICU-ProtocolSummary 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 n28 or placebo n28 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
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 n28 or placebo n28 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None