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Status:

UNKNOWN

Cistanche Total Glycosides for Amyotrophic Lateral Sclerosis: A Randomized Control Trial (RCT) Study Assessing Clinical Response

Lead Sponsor:

Peking University

Conditions:

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

This study will examine the effectiveness of Cistanche Total Glycosides(CTG) in treating patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult...

Detailed Description

This study will examine the effectiveness of Cistanche Total Glycosides(CTG) in treating patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult...

Eligibility Criteria

Inclusion

  • All subjects must have a verifiable diagnosis of ALS of 0.5 to 2 years' duration.
  • The diagnosis must be supported by the Revised Criteria of the World Federation of Neurology.
  • The grades of diagnosis must be clinically definite ALS or clinically probable ALS.
  • All subjects must be over age 18 and below 65.
  • The ALS is mildly to moderate based on ALS Health State Scale.
  • Electrophysiological features show CMAP amplitude of motor nerve normal or mild declining.
  • Serum creatine kinase is normal or mild upper, less than 500U/L.

Exclusion

  • If anyone of the above eligibility requirements is not met
  • Use of any other investigational agent within 30 days beginning the treatment phase of this study
  • Severe cardiac, pulmonary, hepatic or/and hematic disease
  • HIV positivity or signs and symptoms consistent with HIV infection
  • Pregnant or nursing women
  • History of cancer with less than 5 years documentation of a disease-free state
  • History of anaphylactic reaction or hypersensitivity to G-CSF or proteins derived from E.coli
  • Alcohol or drug abuse in recent 1 year
  • Can't understand or obey the rules of treatment
  • Blood donor in recent 30 days

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2010

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00753571

Start Date

January 1 2008

End Date

October 1 2010

Last Update

December 30 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Dongsheng Fan, MD; Liping Wang,MD

Beijing, Beijing Municipality, China, 100191