Pilot Study on Traditional Chinese Medicine and Food Allergy

NCT ID: NCT02490813

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-18
• Study Completion Date: 2023-02-18

Brief 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.

Detailed Description

The investigators aim to recruit 24 subjects for the present study. Subjects will be randomized into two groups, control group (n=12) and treatment group (n=12). At recruitment all subjects will be required to stop anti-allergic medicines and Chinese medicines as a wash out period for two weeks (week 1 and week 2). They will be required to keep a record of their symptoms and peak flow rates twice daily throughout the entire study. Skin prick test will be performed with a panel of commercially available skin test solutions for cod, shrimp and crab (ALK). Total and specific IgE as well as total and specific IgG4 for fish and shellfish will be measured (by the HKSH laboratory or CUHK laboratory). Graded open cod, shrimp or crab challenge will be performed as described later at HKSH in each patient to determine the baseline tolerance level to fish or shellfish, using freeze-dried cod, shrimp or crab as appropriate.

After determining the baseline tolerance level, subjects in the treatment group will take 2 grams of the CHFX or placebo daily for 8 weeks (week 4 to week 11). The placebo powder consists of food grade medicinal starch blended with coloring agent. After the 8 weeks of treatment, skin prick tests, blood tests as at baseline and oral challenges will be repeated (week 12). During the study subjects will be requested to consume their normal diet but avoiding fish and shellfish, with no consumption of any other Chinese herbal medication. They can take anti-allergic medicines as necessary but will note when medicines are taken in their symptom and peak flow diary.

Conditions

Allergy to Fish; Allergy to Shrimp; Allergy to Crab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

This arm will receive the placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo will be starch with colorings

Treatment - Chinese Herbal Formula - X

This arm will receive the Chinese Herbal Formula - CHFX as treatment to their existing fish, shrimp or crab allergy.

Group Type: EXPERIMENTAL

Treatment - Chinese Herbal Formula - X

Intervention Type: DIETARY_SUPPLEMENT

Wu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens).

Interventions

Treatment - Chinese Herbal Formula - X

Wu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo will be starch with colorings

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Hong Kong Sanatorium & Hospital

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

June Chan, Master

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Sanatorium & Hospital

Locations

Hong Kong Sanatorium & Hospital

Happy Valley, , Hong Kong

Countries

Hong Kong

Other Identifiers

ALC-002

Identifier Type: -

Identifier Source: org_study_id