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 range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.