An interventional study of itraconazole and lactobacillus gasseri in Vulvovaginal Candidiasis, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-11.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.
Objective:
Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.
Design:
Single-centre, prospective, randomized.
Sample:
One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.
Methods:
Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 144 is above the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).
Drug: itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
Drug: itraconazole · Drug: lactobacillus gasseri
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.
Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
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.
Candida Culture Free After Maintenance Therapy
candida culture free (monthly vaginal cultures were obtained)
Time frame: 12 months
| Milestone | Itraconazole | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy |
|---|---|---|---|
| Started | 48 | 50 | 46 |
| Completed | 23 | 25 | 23 |
| Not completed | 25 | 25 | 23 |
| Withdrew: Lost to follow-up | 25 | 25 | 23 |
candida culture free (monthly vaginal cultures were obtained)
| participants | Itraconazole | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy |
|---|---|---|---|
| Candida Culture Free After Maintenance Therapy | 18 | 19 | 9 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Itraconazole | — | 0/48 (0%) | 0/48 (0%) |
| Itraconazole + Lactobacilli Agent | — | 0/50 (0%) | 0/50 (0%) |
| Classic Homeopathy (CH) | — | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | Itraconazole | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 50 | 46 | 144 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Itraconazole | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy | Total |
|---|---|---|---|---|
| Mean | 30.5 ± 7.8 | 30.4 ± 7.4 | 30.3 ± 8.0 | 30.4 ± 7.4 |
| Sex: Female, Male(Participants) | Itraconazole | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy | Total |
|---|---|---|---|---|
| Female | 48 | 50 | 46 | 144 |
| Male | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Itraconazole | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy | Total |
|---|---|---|---|---|
| Austria | 48 | 50 | 46 | 144 |
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna