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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a virtual, double-blind, two-arm, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will take the CanXida Remove Candida Cleansing Formula RMV or a placebo product daily and complete questionnaires at Baseline, Week 6, and Week 12. Candida microbiome testing will be conducted via stool sample at Baseline and Week 12.
The participants will all be blinded to the name of the test brand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CanXida Supplement | Experimental | All participants will adhere to the following treatment regime: Day 1-7: 1 tablet per day Day 8-22: 2 tablets per day Day 23- 84: 3 tablets per day The product should always be taken with the first meal of the day. |
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| Placebo | Placebo Comparator | All participants will adhere to the following treatment regime: Day 1-7: 1 tablet per day Day 8-22: 2 tablets per day Day 23- 84: 3 tablets per day The product should always be taken with the first meal of the day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CanXida Remove (Formula RMV) | Dietary Supplement | Supplement composed of a 12 ingredient anti-fungal, anti-bacterial & anti-parasite formula. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12] | Measured via gut microbiome analysis. Participants will provide a stool sample for the analysis. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vaginal health symptoms. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires. Questionnaires will use a Likert scale (0-5 scale) to measure changes in vaginal itching, vaginal discharge, vaginal discomfort. On the scale, 0= the least favourable score and 5= the most favourable score. | 12 weeks |
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Inclusion Criteria:
Aged between 18-50.
Female.
Self-reported recurrent vaginal issues, including:
May also experience issues with fatigue, lethargy, and gut or digestive issues.
Willing to provide two stool samples during the study.
Willing to adhere to the study protocol.
Willing to avoid introducing any products or any new forms of regular medication or supplements that target candida overgrowth, gut health, or vaginal health for the duration of the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
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Group A = the intervention group Group B = the placebo group
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This study will be double-blinded in that the study participants and the Citruslabs team will be blinded to the intervention or product allocation. Only the sponsor will know which product contains the active ingredients. After the study analysis is complete, the allocation will be unblinded.
| Placebo | Other | Placebo product containing Dicalcium Phosphate, Magnesium Stearate, Stearic Acid, Croscarmellose Sodium, and Silica. |
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| Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12] |
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. |
| 12 weeks |
| Changes in scores on the Bristol Stool Scale. [Timeframe: Baseline to Week 12] | The Bristol Stool Scale is a scale that classifies stools, ranging from the hardest to the softest. Experts consider types 1 and 2 to be uncharacteristically hard and indicative of constipation, while types 6 and 7 are unusually loose and may indicate diarrhea. Medical professionals generally consider types 3, 4, and 5 to be the most typical. | 12 weeks |
| Changes in self-reported energy levels. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. 0= the most favourable and 5= the least favourable response. | 12 weeks |