AsthmaPhase 1NCT00601263
Safety Study of Chinese Herbal Therapy to Treat Asthma
A Phase 1 study testing Anti-Asthma Herbal Medical Intervention (ASHMI) in people with Asthma, run by Xiu-Min Li at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Anti-Asthma Herbal Medical Intervention (ASHMI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2008
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects ages 18-40 and otherwise in good health as determined by medical history and physical examination
- History of asthma documented by a physician
- Documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or RAST testing
- The subject agrees to participate in the study
- Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
Who cannot join
- Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
- Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)
- Abnormal hepatic function
- Abnormal bone marrow function
- Abnormal renal function
- Clinically significant abnormal electrocardiogram
Show all 11Show fewer
- Current uncontrolled moderate to severe asthma with FEV1 <80% predicted
- Participation in another experimental study within 30 days of this study
- History of alcohol or drug abuse (by self report)
- Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test to be considered for this study
- Current smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School Medicine
New York, New York, 10029
About this study
Official title: Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase I
The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system.
Read the detailed description
Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though significant side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown only marginal benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.
We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in atopic patients with asthma and will lead to identifiable changes in serum immunologic markers.
- Conditions
- Asthma
- Being tested
- Anti-Asthma Herbal Medical Intervention (ASHMI)
- Keywords
- Chinese Herbal Therapy, Asthma, Investigational new drug (IND), Complementary and Alternative Medicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Asthma Herbal Medical Intervention (ASHMI)Drug
We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 1a | Active comparator | Low dose ASHMI (2 caps bid). Receives: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI) |
| 1b | Placebo comparator | Placebo 2 caps bid. Receives: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI) |
| 2a | Active comparator | Medium dose ASHMI (4 caps bid). Receives: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI) |
| 2b | Placebo comparator | Placebo 4 caps bid. Receives: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI) |
| 3a | Active comparator | High dose ASHMI (6 caps bid). Receives: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI) |
| 3b | Placebo comparator | Placebo 6 caps bid. Receives: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug safety (absence of severe adverse effects)
Measured: 1 week
Secondary outcomes (10)
Clinically significant changes in electrocardiogram
Measured: 1 week
Clinically significant changes in blood count
Measured: 1 week
Clinically significant changes in serum chemistries
Measured: 1 week
Clinically significant changes in renal function
Measured: 1 week
Clinically significant changes in liver function
Measured: 1 week
Clinically significant changes in urinalysis
Measured: 1 week
Allergen-specific IgE levels
Measured: 1 week
Total IgA level
Measured: 1 week
T-cell cytokine profile
Measured: 1 week
Prostaglandin levels
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiu-Min Li
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Xiu-Min Li, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Wisnivesky, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601263
- Sponsor's protocol ID
- P01AT002647
- Other IDs
- P01AT002647, GCO 04-0206
- Status last verified
- Feb 2012
- First submitted
- 15 Jan 2008
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wen MC, Wei CH, Hu ZQ, Srivastava K, Ko J, Xi ST, Mu DZ, Du JB, Li GH, Wallenstein S, Sampson H, Kattan M, Li XM. Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma. J Allergy Clin Immunol. 2005 Sep;116(3):517-24. doi: 10.1016/j.jaci.2005.05.029.
PubMed 16159618
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase I
- ClinicalTrials.gov ID
- NCT00601263
- Acronym / sponsor ID
- P01AT002647
- Conditions
- Asthma
- Keywords
- Chinese Herbal Therapy, Asthma, Investigational new drug (IND), Complementary and Alternative Medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Xiu-Min LiUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Jan 2008 (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.
The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system.
Detailed description
Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though significant side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown only marginal benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.
We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in atopic patients with asthma and will lead to identifiable changes in serum immunologic markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1a | Active comparator | Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)Low dose ASHMI (2 caps bid). |
| 1b | Placebo comparator | Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)Placebo 2 caps bid. |
| 2a | Active comparator | Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)Medium dose ASHMI (4 caps bid). |
| 2b | Placebo comparator | Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)Placebo 4 caps bid. |
| 3a | Active comparator | Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)High dose ASHMI (6 caps bid). |
| 3b | Placebo comparator | Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)Placebo 6 caps bid. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects ages 18-40 and otherwise in good health as determined by medical history and physical examination
- History of asthma documented by a physician
- Documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or RAST testing
- The subject agrees to participate in the study
- Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
Key exclusion criteria (11 listed)
- Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
- Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)
- Abnormal hepatic function
- Abnormal bone marrow function
- Abnormal renal function
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 |
|---|---|---|
| Anti-Asthma Herbal Medical Intervention (ASHMI)We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days. | Drug | 1a, 1b, 2a, 2b, 3a, 3b |
Primary outcome
Drug safety (absence of severe adverse effects)
Time frame: 1 week
10 secondary outcomes
Clinically significant changes in electrocardiogram
Time frame: 1 week
Clinically significant changes in blood count
Time frame: 1 week
Clinically significant changes in serum chemistries
Time frame: 1 week
Clinically significant changes in renal function
Time frame: 1 week
Clinically significant changes in liver function
Time frame: 1 week
Clinically significant changes in urinalysis
Time frame: 1 week
Allergen-specific IgE levels
Time frame: 1 week
Total IgA level
Time frame: 1 week
T-cell cytokine profile
Time frame: 1 week
Prostaglandin levels
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 16159618Wen MC, Wei CH, Hu ZQ, Srivastava K, Ko J, Xi ST, Mu DZ, Du JB, Li GH, Wallenstein S, Sampson H, Kattan M, Li XM. Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma. J Allergy Clin Immunol. 2005 Sep;116(3):517-24. doi: 10.1016/j.jaci.2005.05.029.
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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.
Juan Wisnivesky, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-Asthma Herbal Medical Intervention (ASHMI) in people with Asthma, run by Xiu-Min Li at 1 site in United States.
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 11 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Drug safety (absence of severe adverse effects) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601263, which also lists 1 linked publication.
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 23 Jan 2018.