An interventional study of Sanchitongshu and Aspirin in Ischemic Stroke and Antiplatelet Effect, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Prevention
This clinical trail will evaluate the effect of Sanchitongshu combined with antiplatelet drugs (Aspirin or Clopidogrel) in the treatment of high-risk ischemic stroke patients in adults. Half of participants will receive SanchiTongshu and one of antiplatelet drugs (Aspirin or Clopidogrel) in combination, while the other half will receive a placebo and one of antiplatelet drugs (Aspirin or Clopidogrel).
The aim of this clinical trail is to evaluate the effect of Sanchitongshu in the treatment of high-risk ischemic stroke patients in adults. All patients included in the study should meet the inclusion criteria. All participants will receive one of antiplatelet drugs (Aspirin or Clopidogrel). Half of participants will receive Sanchitongshu and Aspirin or Clopidogrel, while the other half will receive a placebo and Aspirin or Clopidogrel. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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At least one of the following (a-c):
Exclusion Criteria:
Drug: SanchiTongshu The study drugs were manufactured according to Good Manufacturing Practice (GMP) by the Pharmaceutical Factory of Chengdu Huasun Group Inc. Ltd. and presented in the form capsules. Every Sanchitongshu capsule weighed 200 mg, contained 100 mg of panaxatriol saponin (PTS) and 100 mg inactive excipient (starch). PTS comprised of dried extracts from roots of Radix Notoginseng, and had been standardised with respect to Ginsenoside Rg1 (50%), Ginsenoside Re (6%), Notoginsenoside R1 (11%). The amounts of the active ingredients were determined by analytical RP-HPLC using an acetonitrile-water gradient system as mobile hase. The peaks were detected by UV-DAD. Drug: Aspirin or Clopidogrel
Drug: Sanchitongshu · Drug: Aspirin · Drug: Clopidogrel
Drug: placebo of Sanchitongshu The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch). Drug: Aspirin or Clopidogrel
Drug: Aspirin · Drug: Clopidogrel · Drug: placebo of Sanchitongshu
SanchiTongshu capsule produced by Chengdu Huashen Group Co., Ltd.
Also known as: Radix/Rhizoma Notoginseng extract
Aspirin produced by Bayer Co., Ltd.
Also known as: Bayaspirin Enteric-coated Tablets
Clopidogrel produced by Shenzhen Salubris Co., Ltd.
Also known as: Clopidogrel Bisulfate
SanchiTongshu palcebo capsule contained dark brown muscovada sugar and the same inactive excipient (starch). Produced by Chengdu Huashen Group Co., Ltd.
Also known as: Placebo
New stroke attack
Any type of stroke events attack or recurrence
Time frame: 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2019 (actual). Primary completion is estimated for Dec 2020, 15 months after the start.
Of 569 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 15 months is below that.
Counting every sponsor, half of 652 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →