Allergy to FishTCMFANCT02490813
Pilot Study on Traditional Chinese Medicine and Food Allergy
A study testing Treatment - Chinese Herbal Formula - X in people with Allergy to Fish and Allergy to Shrimp, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy to Fish, Allergy to Shrimp, Allergy to Crab
- What is being tested?
- Treatment - Chinese Herbal Formula - X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jun 2015to 18 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Treatment - Chinese Herbal Formula - X, Placebo
- Keywords
- Fish allergy, shrimp allergy, crab allergy, traditional Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment - Chinese Herbal Formula - XDietary supplement
Wu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens).
PlaceboDietary supplement
Placebo will be starch with colorings
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | This arm will receive the placebo. Receives: 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. Receives: Dietary Supplement: Treatment - Chinese Herbal Formula - X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to existing allergen
subjects will be accessed on tolerance to existing allergen via opened oral food challenge
Measured: 8 weeks
Secondary outcomes (2)
Skin prick test result
Skin prick test result to existing allergen
Measured: 8 weeks
Blood test - IgE result
Specific IgE test result to existing allergen
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start18 Jun 2015
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Why it stopped: the study has been on hold throughout 3/10/2020-18/2/2023 due to the hospital regulations for COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to FishStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Sanatorium & Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- June Chan, Master, Principal investigator, Hong Kong Sanatorium & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490813
- Sponsor's protocol ID
- ALC-002
- Acronym
- TCMFA
- Status last verified
- Feb 2023
- First submitted
- 2 Jul 2015
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Traditional Chinese Medicine and Food Allergy
- ClinicalTrials.gov ID
- NCT02490813
- Acronym / sponsor ID
- TCMFA / ALC-002
- Conditions
- Allergy to Fish, Allergy to Shrimp, Allergy to Crab
- Keywords
- Fish allergy, shrimp allergy, crab allergy, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study has been on hold throughout 3/10/2020-18/2/2023 due to the hospital regulations for COVID-19
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hong Kong Sanatorium & HospitalIndustry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboThis arm will receive the placebo. |
| Treatment - Chinese Herbal Formula - X | Experimental | Dietary Supplement: Treatment - Chinese Herbal Formula - XThis arm will receive the Chinese Herbal Formula - CHFX as treatment to their existing fish, shrimp or crab allergy. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment - Chinese Herbal Formula - XWu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens). | Dietary supplement | Treatment - Chinese Herbal Formula - X |
| PlaceboPlacebo will be starch with colorings | Dietary supplement | Control |
Primary outcome
Tolerance to existing allergen
Time frame: 8 weeks
subjects will be accessed on tolerance to existing allergen via opened oral food challenge
2 secondary outcomes
Skin prick test result
Time frame: 8 weeks
Blood test - IgE result
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: the study has been on hold throughout 3/10/2020-18/2/2023 due to the hospital regulations for COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Chan, Master principal investigator
Hong Kong Sanatorium & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment - Chinese Herbal Formula - X in people with Allergy to Fish and Allergy to Shrimp, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the study has been on hold throughout 3/10/2020-18/2/2023 due to the hospital regulations for COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance to existing allergen (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.