The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule (NCT03789760) | Clinical Trial Compass
CompletedPhase 3
The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule
China493 participantsStarted 2019-04-10
Plain-language summary
As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. So the study hypothesis is also that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to confirm the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion Criteria:
* 40 years≤Age≤75 years, female or male.
* With an education at more than (including) 6 years.
* Meet the diagnostic criteria for dementia in Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).
* Meet the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche etl'Enseignement en Neurosciences(NINDS-AIREN) Criteria of Probable Vascular Dementia (1993).
* MRI (magnetic resonance imaging) supports the presence of ischemic cerebrovascular disease, and meets NINDS-AIREN Imaging Criteria; the diameter of each infarct≤ 30mm(And the perivascular spaces and cerebral microbleeds were excluded).
* Modified Hachinski Ischemic (mHIS) Scale ≥ 4.
* Hamilton depression scale (HAMD) ≤ 17.
* Patients with mild or moderate VaD: 10 ≤ MMSE ≤ 26 and 1 ≤ CDR ≤ 2.
* Willing to participate in this study and could sign the informed consent form by him/herself and lawful guardian prior to the study.
* The subjects must have a care giver who are cognitively normal (MMSE scores: illiteracy\> 17 points, 1 - 6 years of education \> 20 points, 7 years and above of education \> 24 points). The care giver shall also be able to take care of the patient at least 4 days a week for more than 4 hours a day while he or she can accompany the subjects to attend each visit. During the trial, a new caregiver must have MMSE score and the results would be presented in forms of subjects in the attachment.
Exclusion Criteria:
* Pati…