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| Name | Class |
|---|---|
| Galenica SA | UNKNOWN |
| Olvos Science SA | UNKNOWN |
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This single-arm, open-label small interventional proof-of-concept (POC) study study aims:
Cretan IAMA (CAPeo) is an essential oil mixture of three native herbs of Crete (Thymbra capitata (L.) Cav., Salvia fruticosa Mill. and Origanum dictamnus L.), which exhibits remarkable in vitro antiviral activity against Influenza A & B and the Human Rhinovirus HRV-14 strains, decreasing the symptoms of upper respiratory tract viral infections. It has also been proven safe in experimental animals and humans. There is currently a strong unmet medical need for safe and effective therapeutic regimens for patients in ambulatory settings. Given its properties, it was, therefore, deemed both appropriate and urgent to explore its potential in the context of COVID-19 for patients in primary care settings. It was also deemed important to investigate the Cretan IAMA (CAPeo) regarding prophylactic treatment for people coming in close contact with these ambulatory patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cretan IAMA (CAPeo) | Experimental | All patients are to receive Cretan IAMA (CAPeo) from Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cretan IAMA | Dietary Supplement | Cretan IAMA (CAPeo) soft gels, 1 ml/day of a 1.5% essential oil combination from three aromatic plants (Thymbra 59 capitata (L.) Cav., Origanum dictamnus L., Salvia fruticosa Mill.) in extra virgin olive oil |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with symptom resolution | Number of patients with symptoms recorded at baseline resolving at 2 weeks (14 days) or sooner | 2 weeks (14 days) |
| Number of people cohabiting with a patient not developing VRI symptoms | Number of people cohabiting with a patient who did not develop VRI symptoms (per patient) at 2 weeks (14 days) | 2 weeks (14 days) ) |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to full symptom resolution | Median time to full symptom resolution, including those emerging after Day 1 adjusted for symptoms emerging after Day 1 (Baseline symptoms) | 2 weeks (14 days) |
| Intensity of symptoms |
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Inclusion Criteria:
For the patients:
For the people cohabiting with patients:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christos Lionis | University of Crete | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cretan Medicare | Heraklion | Crete | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9872255 | Result | Lionis C, Faresjo A, Skoula M, Kapsokefalou M, Faresjo T. Antioxidant effects of herbs in Crete. Lancet. 1998 Dec 19-26;352(9145):1987-8. doi: 10.1016/S0140-6736(05)61333-5. No abstract available. | |
| 25645191 | Result | Duijker G, Bertsias A, Symvoulakis EK, Moschandreas J, Malliaraki N, Derdas SP, Tsikalas GK, Katerinopoulos HE, Pirintsos SA, Sourvinos G, Castanas E, Lionis C. Reporting effectiveness of an extract of three traditional Cretan herbs on upper respiratory tract infection: results from a double-blind randomized controlled trial. J Ethnopharmacol. 2015 Apr 2;163:157-66. doi: 10.1016/j.jep.2015.01.030. Epub 2015 Jan 30. |
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|
Intensity of symptoms, incl. of those emerging after Day 1 (Baseline symptoms), and adjusted for symptoms emerging after Day 1 (Baseline symptoms), scoring on the seven-point Likert scale based on a questionnaire adapted from the Wisconsin Upper Respiratory System Survey - A seven-point Likert scale allowed recording 131 of reported symptoms starting from 1 (minor) to 2 (very mild) and 3 (mild), 4 (somewhat moderate) and 132 5 (moderate) and culminating to 6 (severe) and 7 (very severe).
| 2 weeks (14 days) |
| Duration of symptoms | Duration of symptoms, incl. of those emerging after Day 1 (Baseline symptoms) and adjusted for symptoms emerging after Day 1 (Baseline symptoms) | 2 weeks (14 days) |
| Number of patients whose symptoms never exceeded a score of 3-4 (mild) | Number of patients whose symptoms never exceeded a score of 3-4 (mild) on the seven-point Likert scale based on a questionnaire adapted from the Wisconsin Upper Respiratory System Survey | 2 weeks (14 days) |
| Quality of life (QoL) of patients | EQ-5D-5L measurement of QoL | 2 weeks (14 days) |
| Result | Tseliou, M., Pirintsos, S. A., Lionis, C., Castanas, E., and Sourvinos, G. (2019). Antiviral effect of an essential oil combination derived from three aromatic plants (Coridothymus capitatus (L.) Rchb. f., Origanum dictamnus L. and Salvia fruticosa Mill.) against viruses causing infections of the upper respiratory tract. J. Herb. Med. 17-18, 100288. doi:10.1016/j.hermed.2019.100288. |
| 33390932 | Result | Pirintsos SA, Bariotakis M, Kampa M, Sourvinos G, Lionis C, Castanas E. The Therapeutic Potential of the Essential Oil of Thymbra capitata (L.) Cav., Origanum dictamnus L. and Salvia fruticosa Mill. And a Case of Plant-Based Pharmaceutical Development. Front Pharmacol. 2020 Nov 24;11:522213. doi: 10.3389/fphar.2020.522213. eCollection 2020. |
| 28934952 | Result | Anastasaki M, Bertsias A, Pirintsos SA, Castanas E, Lionis C. Post-market outcome of an extract of traditional Cretan herbs on upper respiratory tract infections: a pragmatic, prospective observational study. BMC Complement Altern Med. 2017 Sep 21;17(1):466. doi: 10.1186/s12906-017-1978-7. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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