NCT00895453

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

May 8, 2009

Completed
Last Updated

November 11, 2016

Status Verified

May 1, 2009

Enrollment Period

5.8 years

First QC Date

January 16, 2009

Results QC Date

January 16, 2009

Last Update Submit

September 26, 2016

Conditions

Vulvovaginal Candidiasis

Keywords

recurrent vulvovaginal candidiasisitraconazoleclassic homeopathy

Outcome Measures

Primary Outcomes (1)

  • Candida Culture Free After Maintenance Therapy

    candida culture free (monthly vaginal cultures were obtained)

    12 months

Study Arms (3)

itraconazole

ACTIVE COMPARATOR

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

Drug: itraconazole

itraconazole + lactobacilli agent

ACTIVE COMPARATOR

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

Drug: itraconazoleDrug: lactobacillus gasseri

classic homeopathy (CH)

ACTIVE COMPARATOR

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)

Interventions

itraconazoleDRUG

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

itraconazoleitraconazole + lactobacilli agent
lactobacillus gasseriDRUG

Lactobacillus vaginal tablets monthly given through 6 days

itraconazole + lactobacilli agent
classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)DRUG

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 (CH)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients over 18 years, premenopausal
  • Negative pregnancy test
  • Signed informed consent
  • At least 4 Episodes of Candidiasis within the last year
  • Candida detectable by culture
  • Negative Hepatitis- and HIV-Serology
  • No Allergy to Itraconazole

You may not qualify if:

  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Medical School

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Itraconazole6-phospho-beta-galactosidaseIron, Dietary

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesIron CompoundsInorganic Chemicals

Results Point of Contact

Title
Armin Witt MD
Organization
Vienna Medical School
armin.witt@meduniwien.ac.at
+43140400

Study Officials

  • Armin Witt, MD

    Vienna Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2009

First Posted

May 8, 2009

Study Start

May 1, 2000

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

November 11, 2016

Results First Posted

May 8, 2009

Record last verified: 2009-05

Locations

AU(1)