An interventional study of Calculus bovis sativus (CBS) in Ischemic Cerebrovascular Disease, Acute Ischemic Stroke and Cerebral Small Vessel Diseases, sponsored by Tongji Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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Among 749 studies in Ischemic Stroke with a site in China — 376 open to participants now, 395 under way, 76 of them phase 3. Ischemic Stroke · China.
Among the 749 studies in Ischemic Stroke with a site in China, this one is the 308th largest by planned enrollment of the 563 interventional ones that give a count, is one of 102 that started in 2024, is one of 246 with no phase, reaches primary completion later than 370 of the 394 other live ones, and was the 465th registered.
2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.
Browse Ischemic Stroke studies →376 of the 749 studies in Ischemic Stroke with a site in China are open now. Recruiting first, the newest first:
Xidian University · Sites in China
Ages 18+
The First Affiliated Hospital of Zhengzhou University · Sites in China
Ages 18+
Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Sites in China
Ages 18–85
Yongjun Wang · Sites in China
Ages 18+
The First Affiliated Hospital of Anhui Medical University · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
749 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 42 · Phase 2 110 · Phase 3 134 · Phase 4 70
First in 2000; this study’s year is marked. 102 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 230 is above the median of 120 across 1,780 interventional studies indexed under Ischemic Stroke.
Median enrollment 266 across the 563 interventional studies, 625 across the 186 observational. Of the 235 that completed or were terminated, 10 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
79 of 749 have an industry lead sponsor. The 10 most frequent:
Tongji Hospital is the lead sponsor of 387 studies on the registry; 210 are open to participants now.
Tongji Hospital has 5 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
110 of the studies in Ischemic Stroke with a site in China that are under way reach primary completion within a year, 23 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06559241Phase 3Capital Medical UniversityRemote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT） | 2026-11 |
| NCT06615726Phase 3Capital Medical UniversityRegular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis | 2026-11-19 |
| NCT06658197Phase 3Xuanwu Hospital, BeijingEfficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke | 2026-12-01 |
| NCT06749834Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityIntravenous Thrombolysis and NOAC | 2026-12-31 |
| NCT07335107Phase 3Beijing Tiantan HospitalIntravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion | 2027-01-31 |
Add all 110 to your calendar (.ics) → With an account.
Among the 749 studies in Ischemic Stroke with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The most common cause of death for Chinese patients is ischemic cerebrovascular diseases(ICVD), particularly cerebral infarction. It places a heavy burden on people, families, and society as a whole and poses considerable risks of death and disability. The disease known as CSVD has a subtle beginning, is difficult to identify, and is frequently detected only after it progresses to the point of vascular cognitive dysfunction. The primary ischemia necrosis of brain nerve cells and the activation of inflammatory cells are their pathologic processes.
According to historical Chinese medical documents, bezoar possesses properties that can help prevent seizures, treat strokes, enhance cognitive function and mental well-being, and stimulate alertness. Calculus Bovis Sativus (CBS) is the most authentic formulation of bezoar ingredients compared to other bezoar products. It has received approval from the China Food and Drug Administration for the essential treatment of comatose patients. CBS consists of three primary constituents: bilirubin, bile acids, and taurine. Scientific evidence has demonstrated that all of these components possess anti-inflammatory, antioxidant, and neuroprotective properties.
The investigators' objective is to carry out an investigator-initiated clinical study to assess the efficacy of orally administered CBS in treating ischemic cerebrovascular diseases in humans.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ICVD cohort:
Must be diagnosed with
① Ischemic stroke, according to the "Diagnosis Points of Various Cerebrovascular Diseases" of the Fourth National Cerebrovascular Disease Academic Conference, the main clinical diagnosis is ischemic stroke (cerebral infarction), 1 point ≤ NIHSS ≤ 24 points, and mRS ≤ 3 points; or ② Cerebral small vessel disease, according to the results of conventional sequence MRI examination, Fazekas score on T2 FLAIR sequence ≥ 3 points (0-6 points, the sum of paraventricular WMH score + subcortical WMH score), and mRS ≤ 3 points (mRS ≤ 4 points for those with recent subcortical small infarction within 1 month).
Healthy cohort:
Exclusion Criteria:
Medical History and Current Health Status 1.1. Any cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.
1.2. Any untreated teratoma or thymoma at the baseline visit (randomization) 1.3. Other causes of symptoms, including CNS infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.
1.4. History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.
1.6. Planned surgery during the study (except minor surgery). 1.7. History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.
1.8. Current or history of malignant disease, including solid tumors and hematologic (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor/sponsor approval.
1.9. A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.
1.10. A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).
1.11. A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.
1.12. A history of blood donation (1 unit or more), plasma donation, or donation within 90 days before screening.
1.13. Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.
1.14. Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.
1.15. Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.
1.16. The subject's mental or physical condition will hinder the evaluation of efficacy and safety.
1.17. Systolic blood pressure >150 mmHg or \<90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.
1.18. Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant abnormalities, including >450 msec (male) or 470 msec (female), where QTc is determined based on the Fridericia correction method, within 3 months prior to the screening visit.
1.19. Planned elective procedures or surgeries at any time after signing the ICF by follow-up visit.
1.20. Any condition that affects the absorption of study treatment (e.g., gastrectomy).
1.21. History of to heparin or history of heparin-induced thrombocytopenia.
1.22. Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.
Risk of infection 2.1. History of (HIV) or positive test results at screening.
2.2. Current infection with (defined as positive HCV antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.
2.3. Current infection with (defined as positive HBsAg and/or positive total anti-HBc). Subjects who are immune to hepatitis B after previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.
2.4. Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).
2.5. History of TB diagnosis or positive latent TB test result (defined as positive IGRA test result or 2 consecutive times.
2.6. Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.
2.7. Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.
2.8. Any live or within 28 days prior to baseline (visit 1) or planned during the study.
2.9. to all of the following salvage therapies: rituximab, IVIG, high-dose , or IV cyclophosphamide.
2.10. History of or receipt of the following treatments:
Laboratory Values 3.1. Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).
3.2. Any of the following blood test abnormalities at Screening:
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4.3. History of alcohol or drug abuse in the past year (determined by the investigator).
4.4. Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.
4.5. Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.
4.6. History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by C-SSRS at screening.
4.7. Unwilling or unable to comply with protocol requirements. 4.8. The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.
4.9. The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in ICVD cohort of this arm will receive general therapy plus CBS.
Drug: Calculus bovis sativus (CBS)
Subjects in ICVD cohort of this arm will only receive general therapy.
Subjects in healthy cohort of this arm will only receive CBS.
Drug: Calculus bovis sativus (CBS)
Subjects will orally receive 100mg CBS per day from day 1 to day 84.
The Modified Rankin Scale (mRS)
To assess mRS of subjects within 12 weeks after treatment initiation
Time frame: Up to 12 weeks after treatment initiation
The National Institutes of Health Stroke Scale, NIHSS
To assess NIHSS of subjects within 12 weeks after treatment initiation
Time frame: Up to 12 weeks after treatment initiation
Incidence and Severity of AEs and SAEs
To evaluate the incidence of AEs and SAEs occurred within 14 weeks after treatment initiation
Time frame: Up to 14 weeks after treatment initiation
The number of newly increased cerebral infarction on diffusion-weighted imaging at week 12 compared with baseline (visit 1) and control group.
Time frame: Up to 12 weeks after treatment initiation
The number of lacunes on T1 weighted imaging at week 12 compared with baseline (visit 1) and control group.
Time frame: Up to 12 weeks after treatment initiation
The number of white matter hyper-intensities on T2 flair weighted imaging at week 12 compared with baseline (visit 1) and control group.
Time frame: Up to 12 weeks after treatment initiation
The number of cerebral microbleeds on susceptibility weighted imaging at week 12 compared with baseline (visit 1) and control group.
Time frame: Up to 12 weeks after treatment initiation
The score of Mini-mental State Examination (MMSE) at week 12 compared with baseline (visit 1) and control group.
The score of MMSE ranges from 0 to 30, and 30 represents the best.
Time frame: Up to 12 weeks after treatment initiation
The score of Montreal cognitive assessment scale (MoCA) at week 12 compared with baseline (visit 1) and control group.
The score of MoCA ranges from 0 to 30, and 30 represents the best.
Time frame: Up to 12 weeks after treatment initiation
The score of subjective cognitive decline questionnaire (SCD) at week 12 compared with baseline (visit 1) and control group.
The score of SCD ranges from 0 to 9, and 9 represents the worst.
Time frame: Up to 12 weeks after treatment initiation
The score of Hamilton Anxiety Scale at week 12 compared with baseline (visit 1) and control group.
The score of Hamilton Anxiety Scale ranges from 0 to 56, and 56 represents the worst.
Time frame: Up to 12 weeks after treatment initiation
The score of Hamilton Depression Scale at week 12 compared with baseline (visit 1) and control group.
The score of Hamilton Depression Scale ranges from 0 to 81, and 81 represents the worst.
Time frame: Up to 12 weeks after treatment initiation
The score of 36-item Short-Form (SF-36) at week 12 compared with baseline (visit 1) and control group.
The score of SF-36 ranges from 0 to 100, and 100 represents the best.
Time frame: Up to 12 weeks after treatment initiation
The incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) events at week 14 compared with baseline (visit 1) and control group
Time frame: Up to 14 weeks after treatment initiation
Fecal flora abundance at week 12 compared with baseline (visit 1).
Time frame: Up to 12 weeks after treatment initiation
Fecal metabolomics analysis at week 12 compared with baseline (visit 1).
Time frame: Up to 12 weeks after treatment initiation
Profiling of cell subtypes at week 12 compared with baseline (visit 1).
Time frame: Up to 12 weeks after treatment initiation
The value of SUVmax and ratio of T/B of inflammatory lesion in 18F-DPA-714 PET/MR imaging examinations at week 12 compared with baseline (visit 1)
Time frame: Up to 12 weeks after treatment initiation
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Jul 2029, 59 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 59 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.