Multi-Gyn ActiGel is effective to treat vaginal infections and relief symptoms related to this condition.
ID
Bron
Aandoening
Vaginal discomforts; bacterial vaginosis; vaginal yeast infection; candidiasis
Ondersteuning
Performer:
Dr. Unnop Jaisamrarn
Associate Professor
Dept. of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn University
Bangkok, Thailand
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Clinical cure of vaginal infection as diagnosed by the investigator
- Reduction in severity of patient vaginal complaints
Achtergrond van het onderzoek
Many women suffer from vaginal infections (mostly candidiasis or bacterial vaginosis) and associated complaints such as itch, malodor and abnormal discharge. Although these conditions hardly ever have serious medical consequences, they can severele affect the quality of life of women that suffer from these conditions. Standard treatment of vaginal infections consists of antibiotic or antimycotic therapy, but these drugs have several side-effects and also recurrence rates are very high. Multi-Gyn ActiGel is a natural alternative to antimicrobial agents that contains patented anti-adhesive polysaccharides (called 2QR-complex) to correct the healthy vaginal microflora. In this study we aim to assess the efficacy of ActiGel over a placebo gel to treat vaginal infections and the associated complaints. Multi-Gyn ActiGel is a substance-based medical device class IIa.
Doel van het onderzoek
Multi-Gyn ActiGel is effective to treat vaginal infections and relief symptoms related to this condition.
Onderzoeksopzet
Women will be treated for 5 days, and will return to the gynaecologist between day 5-8 from the start of treatment
Onderzoeksproduct en/of interventie
Women that present themselves with a vaginal infection at the gyneacologist will use Multi-Gyn ActiGel or placebo for 5 days, twice per day. At study entry and at follow up women will be physically examined, and a vaginal swab will be obtained for microscopy, cytology and pH measurement.
Publiek
Paul Kwakman
Delftechpark 55
Delft 2628 XJ
The Netherlands
+31 15 251 2896
p.kwakman@bioclin.com
Wetenschappelijk
Paul Kwakman
Delftechpark 55
Delft 2628 XJ
The Netherlands
+31 15 251 2896
p.kwakman@bioclin.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Women suffering from a vaginal infection
• Age between 18 and 60 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Women with a a sexually transmitted disease
• Pregnancy or planned pregnancy during the study period
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL5331 |
NTR-old | NTR5440 |
Ander register | 221/56 : IRB Chulalongkorn University |