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Clinical Trial Summary

Spinocerebellar ataxia type 3 (SCA3) is one of autosomal dominant hereditary ataxias. Standing imbalance, unsteady gait, dysmetria, fatigue, and depression would occur gradually. There are no effective treatment or palliative methods for patients in the present days. However, low-dose growth hormone, or its downstream product, insulin-like growth factor I (IGF-1), may deter the progress of SCA3 in transgenic mice. Astragaloside IV (AST) is the main bioactive constituent among Astragali Radix, and possesses neuroprotective function against glutamate-induced toxicity, which is one major pathology of SCA3. AST promotes neurogenesis, and increases the protein expression of IGF-1 in ischemic brains of rats. Thus, we designed a randomized, double-blind trial for patients with SCA3, if Astragali Radix is a possible neuroprotective medicine. All the subjects will be recruited from Changhua Christian Hospital. Diagnosis is confirmed by gene test and magnetic resonance image by a neurologist. They will be assigned in random and double blind, prescribed with 3 grams concentrated powder of Astragali Radix or placebo, twice a day, for 12 weeks. After the washout period of 4 weeks, there will be a crossover of placebo or Astragali Radix for another 12 weeks. After that, another 4-week rest will be followed by the end of trial. Check items in five check points include: 1. Blood examination (serum IGF-1, Neurofilament light chain, mitochondria copy number, 8_OHdG, delta-Ct), 2.Neurological exam (Scale for the Assessment and Rating of Ataxia), 3. Questionnaires (Modified Fatigue Impact Scale, Epworth Sleepiness Scale), 4. Handgrip strength test (which is correlated to IGF-1 value in elderly), and 5. serum metabolites, . All the data will be disclosed after the end of trial. Paired-T test or Wilcoxon Ranked Sign Test will be operated in SPSS.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05038306
Study type Interventional
Source Changhua Christian Hospital
Contact Chung-Min Chiu
Phone 886-982-506-067
Email [email protected]
Status Recruiting
Phase Phase 2
Start date May 31, 2021
Completion date October 5, 2021

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