AsthmaPhase 1/2NCT00712296

Effectiveness of Chinese Herbal Therapy for Asthma

A Phase 1/2 study testing ASHMI 4 and ASHMI 12 in people with Asthma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: ASHMI 4 and ASHMI 12
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Aug 2008to 29 Sep 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 through 55 and otherwise in good health as determined by medical history and physical examination
History of asthma documented by a physician for at least 6 months
Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study
The subject agrees to participate in the study
Subjects must have one of the following:
one asthma-related unscheduled visit to an Emergency Department or clinic in the past 12 months

Show all 12Show fewer

One overnight hospitalization in the past 12 months
Disturbed sleep more than twice in the past month
Asthma symptoms ≥8 times in the past month
use of a β2-agonist ≥8 times in the past month
two short courses (3-7 days) of oral corticosteroids in the last 12 months
FEV1 <80% predicted AND Use of inhaled corticosteroid (ICS) for at least 1 month prior to enrollment

Who cannot join

Acute illness (such as cold, flu, etc.) within two weeks before the screening visit
Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including hepatitis virus infection
History of chronic obstructive lung disease, emphysema, or other chronic respiratory condition
Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; Hgb <11 g/dl)
Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)

Show all 12Show fewer

Clinically significant abnormal electrocardiogram
FEV1 <50% predicted
Participation in another experimental therapy study within 30 days of this study
History of alcohol or drug abuse
Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study
Subjects receiving treatment with Omalizumab or immunotherapy for asthma

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

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 II

The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics

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 side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited 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. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.

Conditions: Asthma
Being tested: ASHMI 4, ASHMI 12, Placebo
Keywords: Asthma, alternative medicine, complementary medicine, herbal therapy
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASHMI 4Drug
4 capsules orally twice a day
ASHMI 12Drug
12 capsules orally twice a day
PlaceboDrug
Placebo 6 capsules twice a day

Study groups in NCT00712296
Study group	Role	What they receive
ASHMI 4	Experimental	ASHMI 4 capsules twice a day Receives: Drug: ASHMI 4
ASHMI 12	Experimental	ASHMI 12 capsules twice a day Receives: Drug: ASHMI 12
Placebo	Placebo comparator	Placebo 6 capsules twice a day Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose, Urea and Creatinine Phase I
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Measured: 1 week after receiving active drug or placebo
Sodium, Potassium, Chloride and CO2 Phase I
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1
Measured: 1 week after receiving active drug or placebo
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I
Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1
Measured: 1 week after receiving active drug and placebo
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I
Summary of Laboratory data for White Blood Cell(cells*10^3/uL), Hemoglobin(cells*10^3/uL) and Platelet(cells*10^3/uL)in subjects enrolled in Phase 1
Measured: 1 week after receiving active drug and placebo
Hemoglobin Laboratory Results in Phase I
Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1
Measured: 1 week
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II
Limited to Measurements before discontinuation of ASHMI treatment
Measured: 28 weeks
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II
Limited to Measurements before discontinuation of ASHMI treatment
Measured: 28 weeks
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study
Limited to Measurements before discontinuation of ASHMI treatment
Measured: 28 weeks
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study
Summary of Laboratory data for White Blood Cell Count(cells*10^3/uL) and Platelet (cells*10^3/uL)in Phase II study
Limited to Measurements before discontinuation of ASHMI treatment
Measured: 28 weeks
Laboratory Results for Hemoglobin in Subjects in Phase II Study
Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study.
Limited to Measurements before discontinuation of ASHMI treatment
Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 200829 Sep 2009

First posted9 Jul 2008 (estimated)
Study startAug 2008
Primary completion29 Sep 2009
Study completion29 Sep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00712296
Sponsor's protocol ID: GCO 04-0206
Other IDs: P01AT002647-02
Status last verified: Aug 2020
First submitted: 7 Jul 2008
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. 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 II
ClinicalTrials.gov ID: NCT00712296
Acronym / sponsor ID: GCO 04-0206
Conditions: Asthma
Keywords: Asthma, alternative medicine, complementary medicine, herbal therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 66 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Aug 2008 (actual)
Primary completion: 29 Sep 2009 (actual)
Study completion: 29 Sep 2009 (actual)
First posted: 9 Jul 2008 (estimated)
Results: Posted 25 Aug 2020

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 efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ASHMI 4	Experimental	Drug: ASHMI 4ASHMI 4 capsules twice a day
ASHMI 12	Experimental	Drug: ASHMI 12ASHMI 12 capsules twice a day
Placebo	Placebo comparator	Drug: PlaceboPlacebo 6 capsules twice a day

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Male and female subjects ages 18 through 55 and otherwise in good health as determined by medical history and physical examination
History of asthma documented by a physician for at least 6 months
Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study
The subject agrees to participate in the study
Subjects must have one of the following:

Key exclusion criteria (12 listed)

Acute illness (such as cold, flu, etc.) within two weeks before the screening visit
Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including hepatitis virus infection
History of chronic obstructive lung disease, emphysema, or other chronic respiratory condition
Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; Hgb <11 g/dl)

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
ASHMI 44 capsules orally twice a day	Drug	ASHMI 4
ASHMI 1212 capsules orally twice a day	Drug	ASHMI 12
PlaceboPlacebo 6 capsules twice a day	Drug	Placebo

Primary outcome

Glucose, Urea and Creatinine Phase I
Time frame: 1 week after receiving active drug or placebo
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Sodium, Potassium, Chloride and CO2 Phase I
Time frame: 1 week after receiving active drug or placebo
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I
Time frame: 1 week after receiving active drug and placebo
Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I
Time frame: 1 week after receiving active drug and placebo
Summary of Laboratory data for White Blood Cell(cells*10^3/uL), Hemoglobin(cells*10^3/uL) and Platelet(cells*10^3/uL)in subjects enrolled in Phase 1
Hemoglobin Laboratory Results in Phase I
Time frame: 1 week
Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Time frame: 28 weeks
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Time frame: 28 weeks
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Time frame: 28 weeks
Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study
Time frame: 28 weeks
Summary of Laboratory data for White Blood Cell Count(cells*10^3/uL) and Platelet (cells*10^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for Hemoglobin in Subjects in Phase II Study
Time frame: 28 weeks
Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment

Results and safety

Results posted to the registry on 25 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active, Phase I	12	12
Placebo, Phase I	8	8
Active Phase II (ASHMI 4 Caps)	0	0
Active, Phase II (ASHMI 12 Caps )	0	0
Placebo, Phase II	0	0

Primary outcome: Glucose, Urea and Creatinine Phase I

Time frame: 1 week after receiving active drug or placebo. Mean (Standard Deviation). Unit: mg/dL

Measure	Active Phase I Baseline n = 12	Active Phase I Post Treatment n = 12	Placebo Phase I Baseline n = 8	Placebo Phase I Post Treatment n = 8
Glucose	81 (12)	79 (9)	75 (14)	71 (7)
Urea	13 (3)	13 (3)	16 (4)	17 (5)
Creatinine	0.8 (0.2)	0.8 (0.2)	0.9 (0.1)	0.9 (0.2)

Population analysed: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.

Primary outcome: Sodium, Potassium, Chloride and CO2 Phase I

Time frame: 1 week after receiving active drug or placebo. Mean (Standard Deviation). Unit: meq/L

Measure	Active Phase I Baseline n = 12	Active Phase I Post Treatment n = 12	Placebo Phase I Baseline n = 8	Placebo Phase I Post Treatment n = 8
Sodium (meq/L)	139 (2)	140 (2)	139 (3)	139 (1)
Potassium (meq/L)	4 (0.3)	4 (0.4)	4 (0.4)	4 (0.2)
Chloride (meq/L)	103 (2)	103 (1)	102 (1)	102 (2)
Carbon dioxide (meq/L)	24 (3)	23 (2)	24 (2)	24 (2)

Primary outcome: Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I

Time frame: 1 week after receiving active drug and placebo. Mean (Standard Deviation). Unit: IU/L

Measure	Active Phase I Baseline n = 12	Active Phase I Post Treatment n = 12	Placebo Phase I Baseline n = 8	Placebo Phase I Post Treatment n = 8
Serum glutamic pyruvic transaminase (SGPT)	19 (8)	20 (8)	21 (9)	20 (9)
Serum glutamic oxaloacetic transaminase (SGOT)	20 (4)	20 (7)	24 (8)	24 (10)

Primary outcome: Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I

Time frame: 1 week after receiving active drug and placebo. Mean (Standard Deviation). Unit: cells*10^3/uL

Measure	Active Phase I Baseline n = 12	Active Phase I Post Treatment n = 12	Placebo Phase I Baseline n = 8	Placebo Phase I Post Treatment n = 8
White Blood Cell	7 (2)	7 (1)	7 (2)	7 (1)
Platelet	292 (81)	238 (123)	281 (60)	273 (64)

Adverse events

Time frame: Phase I: 1 week Phase II: 28 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Phase I (ASHMI 2 Caps Twice a Day)	0 of 4 (0%)	2 of 4 (50%)	Not reported
Placebo Phase I (2 Caps Twice a Day)	0 of 2 (0%)	2 of 2 (100%)	Not reported
Active Phase I (ASHMI 4 Caps)	0 of 4 (0%)	1 of 4 (25%)	Not reported
Placebo Phase I (4 Caps Twice a Day)	0 of 4 (0%)	2 of 4 (50%)	Not reported
Active Phase I (ASHMI 6 Caps)	0 of 4 (0%)	1 of 4 (25%)	Not reported
Placebo Phase I	0 of 2 (0%)	1 of 2 (50%)	Not reported
Active Phase II (ASHMI 4 Caps Twice a Day)	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
Active Phase II (ASHMI 12 Caps)	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Placebo Phase II	0 of 15 (0%)	3 of 15 (20%)	Not reported

Limitations and caveats (from the sponsor): The Phase II study was stopped after 46 subjects were randomized. Since the number of subjects and the follow-up information did not provide adequate power, all statistical analysis plan was changed to descriptive summaries for each group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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 P Wisnivesky, MD, DrPH 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 1/2 study testing ASHMI 4 and ASHMI 12 in people with Asthma, run by Icahn School of Medicine at Mount Sinai 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 12 inclusion and 12 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 16 Sep 2020. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glucose, Urea and Creatinine Phase I (time frame: 1 week after receiving active drug or placebo). The study lists 10 primary outcomes in all. 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 NCT00712296, 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 16 Sep 2020.