Safety Study of Chinese Herbal Therapy to Treat Asthma

NCT00601263 | Completed Phase 1

• 2 other identifiers: P01AT002647GCO 04-0206
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Chinese Herbal Therapy; Asthma; Investigational new drug (IND); Complementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

• Drug safety (absence of severe adverse effects)

  1 week

Secondary Outcomes (10)

• Clinically significant changes in electrocardiogram

  1 week

• Clinically significant changes in blood count

  1 week

• Clinically significant changes in serum chemistries

  1 week

• Clinically significant changes in renal function

  1 week

• Clinically significant changes in liver function

  1 week

Study Arms (6)

1a

ACTIVE COMPARATOR

Low dose ASHMI (2 caps bid).

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

1b

PLACEBO COMPARATOR

Placebo 2 caps bid.

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

2a

ACTIVE COMPARATOR

Medium dose ASHMI (4 caps bid).

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

2b

PLACEBO COMPARATOR

Placebo 4 caps bid.

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

3a

ACTIVE COMPARATOR

High dose ASHMI (6 caps bid).

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

3b

PLACEBO COMPARATOR

Placebo 6 caps bid.

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

Interventions

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.

1a; 1b; 2a; 2b; 3a; 3b

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xiu-Min Li: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Mount Sinai School Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 16159618 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Juan Wisnivesky, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 23, 2018

Record last verified: 2012-02

Locations

US (1)