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Tests treatment safety and results for Encephalitis
Official title Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis (CBSinEncephalitis)
ClinicalTrials.gov ID: NCT06584045
What this study is testing
What is Calculus bovis sativus (CBS)?
Calculus bovis sativus (CBS) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for encephalitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Based on the records of traditional Chinese medicine, CBS has the functions of purifying the heart, eliminating phlegm, stimulating bile secretion, and soothing the nerves. It has the ability to alleviate fever, coma, delirium, epilepsy, convulsions in youngsters, dental caries, throat swelling, mouth ulcers, carbuncle, and furuncle.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- people must meet the following eligibility criteria at screening to participate in this study. 1.1 for people with autoimmune encephalitis...
- a. Limbic system symptoms: recent memory loss, epileptic seizures, mental and behavioral abnormalities, one or more of the three symptoms.
- b. Encephalitis syndrome: clinical manifestations of diffuse or multifocal brain damage.
- c. Clinical manifestations of involvement of the basal ganglia and/or diencephalon/hypothalamus.
- d. Mental disorder, and the psychiatric specialist believes that it does not meet the non-organic disease. B. Auxiliary examination: one or more of...
You likely can't join if
- Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic...
- Any untreated teratoma or thymoma at the baseline visit (randomization)
- Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders...
- History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except...
- Planned surgery during the study (except minor surgery).
- History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of...
See the full eligibility criteria
Who can join
- people must meet the following eligibility criteria at screening to participate in this study. 1.1 for people with autoimmune encephalitis (hereinafter referred to as AE) of all subtypes 1.1.1 people are able to...
- a. Limbic system symptoms: recent memory loss, epileptic seizures, mental and behavioral abnormalities, one or more of the three symptoms.
- b. Encephalitis syndrome: clinical manifestations of diffuse or multifocal brain damage.
- c. Clinical manifestations of involvement of the basal ganglia and/or diencephalon/hypothalamus.
- d. Mental disorder, and the psychiatric specialist believes that it does not meet the non-organic disease. B. Auxiliary examination: one or more of the following auxiliary examination findings, or combined with related...
- a. Abnormal cerebrospinal fluid: cerebrospinal fluid leukocytosis (\>5×106/L), or cerebrospinal fluid cytology shows lymphocytic inflammation, or specific oligoclonal bands are positive.
- b. Neuroimaging or electrophysiological abnormalities: MRI limbic system T2 or FLAIR abnormal signals, unilateral or bilateral, or other areas of T2 or FLAIR abnormal signals (excluding nonspecific white matter changes...
- c. Specific types of tumors associated with AE, such as limbic encephalitis combined with small cell lung cancer, anti-NMDAR encephalitis combined with ovarian teratoma. C. Confirmatory experiments: positive...
- Possible AEs: meet the three diagnostic criteria of A, B and D.
- Confirmed AEs: meet the four diagnostic criteria of A, B, C and D. 1.1.5. AE symptoms occurred ≤9 months before randomization 1.1.6. people meet new AEs \- New onset: defined as people with NMDA-R or LGI-1 AEs and...
- The mRS score measured at baseline is stable (at least 24 hours) and is ≥2 points.
- Received the first acute first-line treatment within 6 weeks before randomization (baseline visit). 1.1.7. All females of childbearing potential and all males must use contraception during the study and for at least 30...
- Age ≥ 18 years at the time of informed consent
- Informed consent, as appropriate based on patient age, specific site, and national criteria
- Suspected or definite NMDAR AE diagnosis as follows: 1.2.1. Suspected NMDAR encephalitis was diagnosed when all three of the following criteria were met: 1.2.1.1 Rapid onset (less than 3 months) of at least four of the...
- Abnormal (psychiatric) behavior or cognitive dysfunction
- Speech dysfunction (rushing speech, hypospeech, mutism)
- Seizures
- Ataxia, dyskinesia, or rigid/abnormal posture
- Decreased level of consciousness
- Autonomic dysfunction or central hypoventilation 1.2.1.2. At least one of the following laboratory results:
- Abnormal EEG (focal or diffuse slow or disorganized activity, epileptic activity, or extreme delta brushes)
- CSF with pleocytosis or oligoclonal bands 1.2.1.3. Reasonable exclusion of other etiologies and other clear encephalitis syndromes: for example, Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis...
- Aged ≥ 18 years at the time of signing the informed consent form For people who are unable to provide informed consent due to the severity of their illness, the informed consent form may be signed by their legally...
- Diagnosis of AA AE Meet the diagnosis of AE in 1.1, negative for anti-NMDA antibodies and anti-LGI-1 antibodies, and positive for at least one of the other anti-neuronal antibodies. 1.5 for viral encephalitis...
- Primary condition: altered mental status, including decreased level of consciousness, drowsiness, or abnormal mental behavior lasting ≥24 h; or new onset of epileptic seizure
- Secondary condition: fever ≥38 °C (before or within 72 h after onset), or new focal manifestations of the nervous system, or cerebrospinal fluid leukocytes ≥5×10\^6/L, or cerebrospinal fluid cytology showing lymphocytic...
- Confirmatory laboratory test: positive cerebrospinal fluid viral nucleic acid (polymerase chain reaction or metagenomic next-generation sequencing), or positive cerebrospinal fluid and/or serum antiviral antibody IgM
- Reasonable exclusion of other causes 1.6 Healthy cohort:
- Age ≥ 18 years old when signing the informed consent form
- Healthy adult people without underlying diseases
What rules you out
- Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the...
- Any untreated teratoma or thymoma at the baseline visit (randomization)
- Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease...
- 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...
- Planned surgery during the study (except minor surgery).
- History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.
- Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at...
- 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)...
- 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...
- 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...
- A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.
- Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.
- 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.
- 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 childbearing potential must have a negative serum pregnancy test result at...
- The subject's mental or physical condition will hinder the evaluation of how well it works and safety.
- 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...
- people 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 ECG...
- Planned elective procedures or surgeries at any time after signing the Informed Consent Form by follow-up visit.
- Any condition that affects the absorption of study treatment (e.g., gastrectomy).
- History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.
- people with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.
- History of human immunodeficiency virus (HIV) or positive test results at screening.
- Current infection with hepatitis C (defined as positive hepatitis C virus (HCV) antibodies and detectable HCV RNA). people with positive HCV antibodies and HCV RNA below the limit of detection are eligible to...
- Current infection with hepatitis B (defined as positive HBsAg and/or positive total anti-HBc).
- Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).
- History of tuberculosis (TB) diagnosis or positive latent TB test result.
- Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). people with localized fungal infection (e.g., candidiasis, tinea) are eligible...
- Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.
- Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.
- Contraindications to all of the following salvage therapies: rituximab, intravenous immunoglobulin, high-dose corticosteroids, or IV cyclophosphamide.
- History of or receipt of the following treatments: Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time. Stem cell...
- Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).
- Any of the following blood test abnormalities at Screening: a. White blood cell count \ 2 x ULN. f. glomerular filtration rate ≤ 60 mL/min/1.73 m2. g. Lymphocyte count \< lower limit of normal
- Any of the following urine test abnormalities at Screening: a. β-2-microglobulin\>0.3 μg/mL. b. Albumin/creatinine ratio\>22.6 mg/mmol.
- Previous participation in this study.
- Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.
- History of alcohol or drug abuse in the past year (determined by the investigator).
- Pregnant or lactating people, as well as people planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.
- Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.
- History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by Columbia-Suicide Severity Rating Scale at screening.
- Unwilling or unable to comply with protocol requirements.
- 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.
- The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.