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Completed

NCT Number: NCT06257797

Fenugreek: an Emergent Allergen

Fenugreek or Trigonella foenum greacum is an ancient medicinal plant native to the eastern Mediterranean, later spread to Asia (especially in India); it belongs to Rosaceae order, Leguminosae family, subfamily of Papilonaceae and it is used as a medicinal herb, spice or food. It is a component of spice mix, such as curry, and it is also used as a supplement in wheat and corn flour for bread-making. Fenugreek appears to have many health benefits and potential medicinal properties (antioxidant, antidiabetic, hepatoprotective, hypocholesterolemic, antimicrobial, anti-inflammatory, neuroprotective, anticarcinogenic, antiulcer, and antilithigenic) both in vitro and in vivo studies; for this reason it may be increasingly being used as nutraceutical formulations (powder, herbal teas, tablets and various combinations).This study aims to describe patients who came to our operating unit for suspected adverse reaction after ingestion of fenugreek and to highlight possible cross-reactivity between fenugreek and other legumes or other foods. Given the increasing use of novel spices in Mediterranean cuisine and the possible spread of fenugreek-based nutraceuticals, it is relevant to draw attention to possible allergic reactions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Policlinico Universitario G. Martino

Messina, Sicily/Messina, 98124, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 yo
  • history of allergic reactions to spices
  • history of allergic reactions to phytotherapics containing fenugreek

Exclusion criteria

  • age < 18 yo
  • non suggestive history of allergic reactions to spices

Treatment and study plan

Skin prick test

Diagnostic Test

Fenugreek wiil be tested by mixing fenugreek seed powder with saline at non-irritating doses and it will be performed by prick-by-prick test. The skin tests will be read 20 minutes after the execution.

Primary outcomes

  1. Cutaneous sensitization to fenugreek

    Time frame: 1 hour

    Cutaneous sensitization to fenugreek evaluated by the result of skin prick test in patients with suggestive history of allergic reactions to spices.

Secondary outcomes

  1. Cross-reactivity between fenugreek and other legumes and other foods

    Time frame: 1 hour

    Cutaneous sensitization to other legumes (lentil, bean, pea, soy, lupine and peanut) and other foods evaluated by the result of skin prick test in patients with suggestive history of allergic reactions to spices.

Sponsors and collaborators

Lead sponsor

Paola Miciullo

Other

Registry information

Official study title

Fenugreek: New Therapeutic Resource or Emerging Allergen

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.