A Phase 1/2 interventional study of silver citrate complex and acemannan in Candidiasis, Oral, sponsored by CelaCare Technologies, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by CelaCare Technologies, Inc. · Phase 1/2, Interventional, and Treatment
CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.
CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.
48 studies on the registry are indexed under Candidiasis, Oral; 6 are open to participants now.
This study's planned enrollment of 15 is below the median of 70 across 32 interventional studies indexed under Candidiasis, Oral.
Browse Candidiasis, Oral studies →This is the only study on the registry with CelaCare Technologies, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single arm open pilot trial. All participants will receive study drug.
Drug: silver citrate complex and acemannan
Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
Also known as: CelAgace™ OraRinse Solution
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation.
Time frame: Days 1(Baseline), 3, 7 and 14
Reduction in Pain
Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
Time frame: Days 1, 3, 7, 14
Start is estimated for Sep 2024; primary completion for Sep 2024, 0 months later.
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This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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