Chinese Medicine WT for Spinocerebellar Ataxia Type 3
Status:
Recruiting
Trial end date:
2022-10-05
Target enrollment:
Participant gender:
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. The main bioactive constituent
among the Chinese medicine WT possesses neuroprotective function against glutamate-induced
toxicity, which is one major pathology of SCA3. It 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 WT 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 WT or placebo, twice a day,
for 12 weeks. After the washout period of 4 weeks, there will be a crossover of placebo or WT
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.