Assessment of the Clinical Effectiveness of a Herbal Extract (Cretan IAMA) in Patients With Viral Respiratory Infections, Including COVID-19, in Primary Healthcare Settings, and Co-assessment of Its Prophylactic Effect in People Cohabiting With These Patients

NCT04705753 | Completed Phase 2

• 1 other identifier: 78/26.03.2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm, open-label small interventional proof-of-concept (POC) study study aims:

1. 1.to assess the clinical outcomes of patients exhibiting viral respiratory infection (VRI) symptoms and seeking primary healthcare (PHC) services at the time of the COVID-19 pandemic,
2. 2.to assess the clinical effectiveness of the Cretan IAMA (CAPeo), a herbal extract combination, for these patients, including in terms of symptom resolution (symptom frequency, duration) and intensity), and
3. 3.to investigate its prophylactic effect in terms of transmission prevention for people cohabiting with the patients exhibiting VRI symptoms.

Conditions

Covid19; Viral Infection; Respiratory Viral Infection

Keywords

Infectious disease; Herbal Medicine; Botanical Medicine

Outcome Measures

Primary Outcomes (2)

• 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) )

Secondary Outcomes (5)

• Median time to full symptom resolution

  2 weeks (14 days)

• Intensity of symptoms

  2 weeks (14 days)

• Duration of symptoms

  2 weeks (14 days)

• Number of patients whose symptoms never exceeded a score of 3-4 (mild)

  2 weeks (14 days)

• Quality of life (QoL) of patients

  2 weeks (14 days)

Study Arms (1)

Cretan IAMA (CAPeo)

EXPERIMENTAL

All patients are to receive Cretan IAMA (CAPeo) from Day 1.

Dietary Supplement: Cretan IAMA

Interventions

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

Also known as: CAPeo

Cretan IAMA (CAPeo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the patients:
• Any woman or man requesting a home visit and having symptoms characteristic of viral infection, with initial manifestation within the previous 48-72 hrs. Such symptoms may include sudden fever onset, accompanied by one or more of the following symptoms: dry cough, sore throat, nasal congestion, headache, musculoskeletal pain, perspiration, fatigue, malaise, blurry vision, loss of the sense of smell.
• For the people cohabiting with patients:
• Any woman or man cohabiting with study patients.

You may not qualify if:

• Children and adolescents under the age of 18 years;
• Pregnant women;
• Persons suffering from a pre-existing condition preventing them from autonomously providing informed consent.

Sponsors & Collaborators

• University of Crete: lead
• Galenica SA: collaborator
• Olvos Science SA: collaborator

Study Sites (1)

Cretan Medicare

Heraklion, Crete, Greece

Location

Related Publications (5)

• 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.

  PMID: 9872255 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.

  PMID: 25645191 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.

  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.

  PMID: 33390932 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.

  PMID: 28934952 RESULT

MeSH Terms

Conditions

COVID-19; Virus Diseases; Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christos Lionis

  University of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Practice and Primary Healthcare, Director of the Clinic of Social and Family Medicine

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 12, 2021
• Study Start: April 1, 2020
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

GR (1)