Developing chamomile as a potential long COVID therapy: clinical evaluation of Roman chamomile extract in healthy volunteers

Not Applicable

• Conditions: Reduction in release of inflammation markers; Signs and Symptoms

• Registration Number: ISRCTN65089038
• Lead Sponsor: Sibelius Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-12
• Last Update Posted: 26 June 2023
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Healthy young adults aged 18 - 35 years
2. Willing to participate and signed informed consent
3. Ability to understand the background and the purpose of the study
4. Willing to comply with the protocol and the study specific limitations
5. Body Mass Index between 18.5 and 30.0 kg/m² as measured within 30 days prior to start of study
6. Fasting Blood Glucose between 3.9 mmol/L and 5.6 mmol/L as measured within 30 days prior to start of study
7. HbA1c below 40 mmol/mol (5.7%) as measured within 30 days prior to start of study
8. No prior history of CVD

Exclusion Criteria

1. Age <18 or >35 years
2. Body Mass Index <18.5 or >35 kg/m²
3. Type 2 diabetes
4. Type 1 diabetes
5. Resistant hypertension (systolic = 150 and/or diastolic = 90 mmHg) on at least 4 anti-hypertensive medications
6. Hypotension (systolic <100 and/or diastolic < 60 mmHg)
7. Recent operation <6 months
8. Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
9. Birth control pills intake (Contraceptive drugs)
10. Intake of any SAID or NSAID during 4 weeks before or during the study conduction, which may affect the inflammation markers
11. Intake of dietary supplements or homoeopathic remedies (e.g. vitamins, minerals, fish-oils) during 2 weeks before and during the study
12. Females pregnant or lactating or planning a pregnancy during study
13. Any known addiction to drugs and/or alcohol
14. Recent alcohol consumption of more than 21 units/week for more than 3 months
15. Intake of illegal drugs during 4 weeks before and during study conduction (e.g. cannabis, cocaine)
16. Any known allergies
17. On a strict diet or practicing sport extensively
18. Employees of sponsor or institutions conducting the study
19. Current participation in another clinical study
20. Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified