Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Effect of Homeopathic Remedy Kalium Bichromicum on Viscosity and Amount of Sputum Mechanically Ventilated ICU Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326365
Recruitment Status : Unknown
Verified May 2006 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2006
Last Update Posted : October 31, 2007
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
The purpose of this study is to determine whether the homeopathic remedy Kali Bichromium is effective in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU setting.

Condition or disease Intervention/treatment Phase
Mechanically Ventilated ICU Patients Drug: Kali bichromicum 10-60 (C30) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Primary Outcome Measures :
  1. To compare efficacy of Kali bichromicum (C30) in reducing tracheal secretions in mechanically ventilated patients

Secondary Outcome Measures :
  1. 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.
  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. any endotracheally intubated ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment.
  2. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00326365

Layout table for location contacts
Contact: Menachem Oberbaum, M.D. 972-2-6666395

Layout table for location information
Intensive Care Unit, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Contact: Menachem Oberbaum, M.D.    972-2-6666395   
Sponsors and Collaborators
Shaare Zedek Medical Center
Layout table for investigator information
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel

Layout table for additonal information Identifier: NCT00326365    
Other Study ID Numbers: KAL.ICU.2006
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: May 2006
Keywords provided by Shaare Zedek Medical Center:
mechanical ventilation
kalium bichromate