Infection, FungalPhase 2/3NCT03005353
Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
A Phase 2/3 study testing Cumin seed extract and clotrimazole in people with Infection, Fungal, run by Assiut University at 1 site in Egypt.
Trial summary
Fungal infections have increased over the last two decades, largely because of the increasing size of the population at risk, including patients who are immunocompromised, broad-spectrum antibiotics and intravascular catheter users. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Infection, Fungal
- What is being tested?
- Cumin seed extract and clotrimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 31 Jan 2020
- Phase
- Phase 2/3
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women were 18-49 years old and were married;
- They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study;
- They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis based on direct smear;
- Candidiasis culture was in agreement with clinical symptoms and patient's complaints.
Who cannot join
- Pregnant and lactating women;
- Those who had abnormal uterine bleeding;
- Women with diabetes or autoimmune diseases;
- Women refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Fungal infections have increased over the last two decades, largely because of the increasing size of the population at risk, including patients who are immunocompromised, broad-spectrum antibiotics and intravascular catheter users. Essential oils and other extracts of plants have evoked interest as sources of natural products. They have been shown to possess antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of our knowledge, no study has examined the efficacy of cumin seed extract on relieving vulvovaginal candidiasis in vivo.
- Conditions
- Infection, Fungal
- Being tested
- Cumin seed extract, clotrimazole
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cumin seed extractDrug
patients will receive the drug in suppository form
clotrimazoleDrug
patients will receive the drug in suppository form
| Study group | Role | What they receive |
|---|---|---|
| Cumin seed extract | Experimental | Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days. Receives: Drug: Cumin seed extract |
| clotrimazole | Active comparator | Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days. Receives: Drug: clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with complete cure
cure is defines as absence of symptoms
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start1 Mar 2018
- Primary completion31 Oct 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, FungalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005353
- Sponsor's protocol ID
- CSE
- Status last verified
- Jun 2020
- First submitted
- 23 Dec 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
- ClinicalTrials.gov ID
- NCT03005353
- Acronym / sponsor ID
- CSE
- Conditions
- Infection, Fungal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 29 Dec 2016 (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.
Fungal infections have increased over the last two decades, largely because of the increasing size of the population at risk, including patients who are immunocompromised, broad-spectrum antibiotics and intravascular catheter users. Essential oils and other extracts of plants have evoked interest as sources of natural products. They have been shown to possess antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of our knowledge, no study has examined the efficacy of cumin seed extract on relieving vulvovaginal candidiasis in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cumin seed extract | Experimental | Drug: Cumin seed extractGroup A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days. |
| clotrimazole | Active comparator | Drug: clotrimazoleGroup B will receive conventional clotrimazole vaginal suppositories once daily for 7 days. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women were 18-49 years old and were married;
- They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study;
- They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis based on direct smear;
- Candidiasis culture was in agreement with clinical symptoms and patient's complaints.
Key exclusion criteria (4 listed)
- Pregnant and lactating women;
- Those who had abnormal uterine bleeding;
- Women with diabetes or autoimmune diseases;
- Women refuse to participate in the study.
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 |
|---|---|---|
| Cumin seed extractpatients will receive the drug in suppository form | Drug | Cumin seed extract |
| clotrimazolepatients will receive the drug in suppository form | Drug | clotrimazole |
Primary outcome
The percentage of patients with complete cure
Time frame: one week
cure is defines as absence of symptoms
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 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cumin seed extract and clotrimazole in people with Infection, Fungal, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 4 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 9 Jun 2020. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The percentage of patients with complete cure (time frame: one week). 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 9 Jun 2020.