Pilot Study on Traditional Chinese Medicine and Food Allergy

NCT02490813 | Terminated DMC

• 1 other identifier: ALC-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy to Fish; Allergy to Shrimp; Allergy to Crab

Keywords

Fish allergy; shrimp allergy; crab allergy; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Tolerance to existing allergen

  subjects will be accessed on tolerance to existing allergen via opened oral food challenge

  8 weeks

Secondary Outcomes (2)

• Skin prick test result

  8 weeks

• Blood test - IgE result

  8 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

This arm will receive the placebo.

Dietary Supplement: Placebo

Treatment - Chinese Herbal Formula - X

EXPERIMENTAL

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

Dietary Supplement: Treatment - Chinese Herbal Formula - X

Interventions

Treatment - Chinese Herbal Formula - X DIETARY_SUPPLEMENT

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

Treatment - Chinese Herbal Formula - X

Placebo DIETARY_SUPPLEMENT

Placebo will be starch with colorings

Control

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Sanatorium & Hospital: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Hong Kong Sanatorium & Hospital

Happy Valley, Hong Kong

Location

Study Officials

• June Chan, Master

  Hong Kong Sanatorium & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: June 18, 2015
• Primary Completion: February 18, 2023
• Study Completion: February 18, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

HK (1)