TerminatedNot Applicable

Pilot Study on Traditional Chinese Medicine and Food Allergy

Stopped: the study has been on hold throughout 3/10/2020-18/2/2023 due to the hospital regulations for COVID-19

Hong Kong18 participantsStarted 2015-06-18

Plain-language summary

Recently, there has been an increasing interest in using traditional Chinese medicine for food allergy. The Harvard group has successfully demonstrated the Food Allergy Herbal Formula - FAHF2 completely blocked peanut-induced anaphylaxis in a murine model, and currently being studied in human. Therefore, in collaboration with the Institute of Chinese Medicine, CUHK, the investigators have developed a more simplified Chinese herbal formula - X (CHFX), containing four food-grade Chinese herbs, Wu-mei (Fructus Pruni Mume); Ling-zhi (Gonoderma); Huang-bai (Cortex Phellodendron) and Zhi-su (Perilla frutescens). In the present study, the investigators would like to examine whether there is reduction in allergic symptoms in food challenge after administering the CHFX for 8 weeks. There will be pre- and post- CHFX food challenges and other related tests.

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 8 years or older with a history of allergic reaction to cod, shrimp or crab, manifested by any of the following: urticaria, angioedema, asthma or anaphylaxis, within 60 mins of ingestion. * Having a positive skin prick test to the cod, shrimp or crab as defined by a weal diameter 3 mm greater than the diluent control. * Having a positive oral challenge with freeze-dried cod, shrimp or crab. * Asthma must be under control with a FEV1 of at least 80% predicted value. * Aspirin, anti-histamines/anti-allergic medicines and antidepressants are not permitted for 3 days, one week and two weeks, respectively, before skin testing or oral food challenge. Exclusion Criteria: * Pregnancy. * Requiring systemic glucocorticoids, beta-blockers and ACE inhibitors. * Having poorly controlled asthma, poorly controlled atopic dermatitis prior to study. * Inability to discontinue antihistamines or other medication for skin testing and oral challenges. * Unable to comply with the study protocol for any reason.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tolerance to existing allergen

Timeframe: 8 weeks

Trial details

NCT IDNCT02490813

SponsorHong Kong Sanatorium & Hospital

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-18

View on ClinicalTrials.gov More Allergy to Fish trials