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Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)

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.
 
ClinicalTrials.gov Identifier: NCT00895453
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : May 8, 2009
Last Update Posted : November 11, 2016
Sponsor:
Information provided by:
Medical University of Vienna

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vulvovaginal Candidiasis
Interventions Drug: itraconazole
Drug: lactobacillus gasseri
Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
Enrollment 144
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Itraconazole Itraconazole + Lactobacillus Gasseri Classic Homeopathy
Hide Arm/Group Description itraconazole alone itraconazole + local lactobacillus gasseri [Not Specified]
Period Title: Overall Study
Started 48 50 46
Completed 23 25 23
Not Completed 25 25 23
Reason Not Completed
Lost to Follow-up             25             25             23
Arm/Group Title Itraconazole Itraconazole + Lactobacillus Gasseri Classic Homeopathy Total
Hide Arm/Group Description itraconazole alone itraconazole + local lactobacillus gasseri [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 48 50 46 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 50 participants 46 participants 144 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
 100.0%
50
 100.0%
46
 100.0%
144
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 50 participants 46 participants 144 participants
30.5  (7.8) 30.4  (7.4) 30.3  (8.0) 30.4  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 50 participants 46 participants 144 participants
Female
48
 100.0%
50
 100.0%
46
 100.0%
144
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 48 participants 50 participants 46 participants 144 participants
48 50 46 144
1.Primary Outcome
Title Candida Culture Free After Maintenance Therapy
Hide Description candida culture free (monthly vaginal cultures were obtained)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Itraconazole Itraconazole + Lactobacillus Gasseri Classic Homeopathy
Hide Arm/Group Description:
itraconazole alone
itraconazole + local lactobacillus gasseri
[Not Specified]
Overall Number of Participants Analyzed 23 25 23
Measure Type: Number
Unit of Measure: participants
18 19 9
Time Frame 12 months
Adverse Event Reporting Description Systematik Assessment by using a questionnaire
 
Arm/Group Title Itraconazole Itraconazole + Lactobacilli Agent Classic Homeopathy (CH)
Hide Arm/Group Description

6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).

itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)

6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.

itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)

lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days

CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.

classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed): CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.

All-Cause Mortality
Itraconazole Itraconazole + Lactobacilli Agent Classic Homeopathy (CH)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Itraconazole Itraconazole + Lactobacilli Agent Classic Homeopathy (CH)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/50 (0.00%)   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Itraconazole Itraconazole + Lactobacilli Agent Classic Homeopathy (CH)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/50 (0.00%)   0/46 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Armin Witt MD
Organization: Vienna Medical School
Phone: +43140400 ext 2821
EMail: armin.witt@meduniwien.ac.at
Layout table for additonal information
Responsible Party: Armin Witt, Vienna Medical School
ClinicalTrials.gov Identifier: NCT00895453     History of Changes
Other Study ID Numbers: 134/2000
First Submitted: January 16, 2009
First Posted: May 8, 2009
Results First Submitted: January 16, 2009
Results First Posted: May 8, 2009
Last Update Posted: November 11, 2016