PMID- 19586409
OWN - NLM
STAT- MEDLINE
DCOM- 20091020
LR  - 20240109
IS  - 1557-7708 (Electronic)
IS  - 1075-5535 (Print)
IS  - 1075-5535 (Linking)
VI  - 15
IP  - 7
DP  - 2009 Jul
TI  - Safety and tolerability of an antiasthma herbal Formula (ASHMI) in adult subjects 
      with asthma: a randomized, double-blinded, placebo-controlled, dose-escalation 
      phase I study.
PG  - 735-43
LID - 10.1089/acm.2008.0543 [doi]
AB  - BACKGROUND: Complementary and alternative medicines are increasingly used for the 
      treatment of asthma in Western countries. A novel three-herb antiasthma herbal 
      medicine intervention (ASHMI; Sino-Lion Pharmaceutical Company; Shan Dong China) 
      was demonstrated to be effective and safe in a murine model of asthma and in a 
      preliminary clinical study in China. OBJECTIVE: The objective of this study was 
      to evaluate the safety and tolerability of ASHMI in adult subjects with allergic 
      asthma. DESIGN: Randomized, double-blind, placebo-controlled, dose escalation, 
      phase I trial aimed at developing a botanical drug under the United States Food 
      and Drug Administration Investigational New Drug title. INTERVENTIONS: Subjects 
      received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 
      capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 
      placebo subjects were treated at each dose level. Subjects continued to use their 
      conventional asthma medications for the duration of the study. OUTCOME MEASURES: 
      Vital signs, physical examination, laboratory data, and electrocardiogram data 
      were monitored throughout the study to assess occurrence of adverse events (AEs). 
      Immunomodulatory studies were performed to evaluate the effect of ASHMI on 
      cytokine, chemokine, and growth factor levels. RESULTS: Twenty (20) nonsmoking, 
      allergic subjects with asthma were included in the study. Eight (8) subjects (4 
      ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were 
      observed during the study period. Vital signs, electrocardiogram findings, and 
      laboratory results obtained at pre- and post-treatment visits remained within 
      normal range. No abnormal immunologic alterations were detected. CONCLUSION: In 
      this phase I study, ASHMI appeared to be safe and well tolerated by subjects with 
      asthma. These findings allowed initiation of a larger phase II study to assess 
      the efficacy of ASHMI.
FAU - Kelly-Pieper, Kristin
AU  - Kelly-Pieper K
AD  - Division of Pediatric Pulmonary Medicine, Columbia University, New York, NY, USA.
FAU - Patil, Sangita P
AU  - Patil SP
FAU - Busse, Paula
AU  - Busse P
FAU - Yang, Nan
AU  - Yang N
FAU - Sampson, Hugh
AU  - Sampson H
FAU - Li, Xiu-Min
AU  - Li XM
FAU - Wisnivesky, Juan P
AU  - Wisnivesky JP
FAU - Kattan, Meyer
AU  - Kattan M
LA  - eng
GR  - 1P01 AT002625-0101/AT/NCCIH NIH HHS/United States
GR  - M01-RR00071/RR/NCRR NIH HHS/United States
GR  - P01 AT002647-04/AT/NCCIH NIH HHS/United States
GR  - P01 AT002647-040002/AT/NCCIH NIH HHS/United States
GR  - P01 AT002647/AT/NCCIH NIH HHS/United States
GR  - M01 RR000071-467842/RR/NCRR NIH HHS/United States
GR  - M01 RR000071/RR/NCRR NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - J Altern Complement Med
JT  - Journal of alternative and complementary medicine (New York, N.Y.)
JID - 9508124
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Cytokines)
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - Adult
MH  - Anti-Asthmatic Agents/administration & dosage/*adverse effects
MH  - Asthma/blood/*drug therapy/immunology
MH  - Cytokines/blood
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drugs, Chinese Herbal/administration & dosage/*adverse effects
MH  - Female
MH  - Glycyrrhiza uralensis/*adverse effects
MH  - Humans
MH  - Male
MH  - Phytotherapy/*adverse effects
MH  - Plant Roots
MH  - *Reishi
MH  - Severity of Illness Index
MH  - Sophora/*adverse effects
MH  - Young Adult
PMC - PMC2830609
MID - NIHMS141122
EDAT- 2009/07/10 09:00
MHDA- 2009/10/21 06:00
PMCR- 2010/07/01
CRDT- 2009/07/10 09:00
PHST- 2009/07/10 09:00 [entrez]
PHST- 2009/07/10 09:00 [pubmed]
PHST- 2009/10/21 06:00 [medline]
PHST- 2010/07/01 00:00 [pmc-release]
AID - 10.1089/acm.2008.0543 [pii]
AID - 10.1089/acm.2008.0543 [doi]
PST - ppublish
SO  - J Altern Complement Med. 2009 Jul;15(7):735-43. doi: 10.1089/acm.2008.0543.