Diabetes MellitusPhase 3NCT00353561
Diabetes Mellitus and Vulvovaginal Candidiasis
A Phase 3 study testing Boric and Fluconazole in people with Diabetes Mellitus and Vulvovaginal Candidiasis, run by Indian Council of Medical Research at 1 site in India.
Trial summary
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 66 years, women only
- Conditions the study is for
- Diabetes Mellitus, Vulvovaginal Candidiasis
- What is being tested?
- Boric and Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2004to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients with diabetes mellitus attending Endocrine OPD of All India Institute of Medical Sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of Candida species on culture of high vaginal swab (HVS).
Who cannot join
- Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded.
- Subjects also excluded were those with pregnancy,
- Sexually inactive girls,
- Age > 65 years, renal failure and steroid therapy.
- Patients who did not give consent for pelvic examination,
- Those who were treated for any kind of vaginal discharge during the past three months and who did not comply with boric acid therapy or did not report on 15th day for repeat examination excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
Read the detailed description
A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.
- Conditions
- Diabetes Mellitus, Vulvovaginal Candidiasis
- Being tested
- Boric, Fluconazole
- Medical subject headings
- Diabetes Mellitus, Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoricDrug
Gelatin capsules filled with 600 mg of boric acid
FluconazoleDrug
150 mg oral fluconazole gives once in 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1, Boric acid | Active comparator | 600 mg vaginal pessaries for 14 days Receives: Drug: Boric |
| 2, Fluconazole | Other | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
Measured: 15 days
Secondary outcomes (1)
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startJun 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Council of Medical Research
- Sponsor type
- Other government
- Investigators
- Ravinder Goswami, DM, Principal investigator, All India Institute of Medical Sciences New Delhi, 110029, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353561
- Sponsor's protocol ID
- RHN/Adhoc/23/2003-2004
- Status last verified
- May 2008
- First submitted
- 17 Jul 2006
- Last updated
- 22 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
- ClinicalTrials.gov ID
- NCT00353561
- Acronym / sponsor ID
- RHN/Adhoc/23/2003-2004
- Conditions
- Diabetes Mellitus, Vulvovaginal Candidiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indian Council of Medical ResearchOther government
- Study start
- Jun 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 18 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
Detailed description
A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, Boric acid | Active comparator | Drug: Boric600 mg vaginal pessaries for 14 days |
| 2, Fluconazole | Other | Drug: Fluconazole |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients with diabetes mellitus attending Endocrine OPD of All India Institute of Medical Sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of Candida species on culture of high vaginal swab (HVS).
Key exclusion criteria (6 listed)
- Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded.
- Subjects also excluded were those with pregnancy,
- Sexually inactive girls,
- Age > 65 years, renal failure and steroid therapy.
- Patients who did not give consent for pelvic examination,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoricGelatin capsules filled with 600 mg of boric acid | Drug | 1, Boric acid |
| Fluconazole150 mg oral fluconazole gives once in 14 days | Drug | 2, Fluconazole |
Primary outcome
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
1 secondary outcome
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
- PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravinder Goswami, DM principal investigator
All India Institute of Medical Sciences New Delhi, 110029, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Boric and Fluconazole in people with Diabetes Mellitus and Vulvovaginal Candidiasis, run by Indian Council of Medical Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.