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NCT00353561
Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
Phase 3 trial testing Boric in Diabetes Mellitus in 100 participants. Completed in 1 April 2006.
1 April 2006
Quick facts
| Lead sponsor | Indian Council of Medical Research |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 June 2004 |
| Primary completion | 1 April 2006 |
| Estimated completion | 1 April 2006 |
| Sites | 1 location across India |
Drugs / interventions tested
- Boric — full drug profile →
- Fluconazole (fluconazole) — full drug profile →
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Vulvovaginal Candidiasis — all drugs for Vulvovaginal Candidiasis →
Sponsor
Indian Council of Medical Research
Who can join
Adults 18 to 66, female only, with Diabetes Mellitus or Vulvovaginal Candidiasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
Time frame: 15 days
Sponsor's own description
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00353561
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Indian Council of Medical Research trials
Trials by the same sponsor.
- NCT06377397 — Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates · Phase 3 · not yet recruiting
- NCT03280147 — 7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00353561 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indian Council of Medical Research
- Last refreshed: 21 May 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00353561.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing