Shang Qiu Shi

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial sponsored by Tasly Pharmaceutical Group Co., Ltd. It aims to assess how well Antiwei granules work and how safe they are in adults aged 18 to 65 with recent onset of common cold symptoms. Participants will be randomly assigned to receive either Antiwei granules or a matching placebo. The treatment involves taking one sachet of granules 6 grams orally three times a day, for three days. Both groups follow the same dosing schedule, taking nine sachets total. The study compares outcomes between the Antiwei granule group and the placebo group over this short treatment period. Throughout the trial, participants will be closely monitored with assessments focusing on the cure rate after three days of treatment. Researchers will also track symptom recovery time, remission rate, disappearance of individual symptoms, traditional Chinese medicine syndrome efficacy, changes in symptom severity, occurrence of complications, emergency medication use, and overall cure of cough and cold symptoms. The total participation time includes the three-day treatment and monitoring period to evaluate treatment effects and safety.

Researchers are evaluating the use of albumin combined with endovascular therapy in patients who have suffered an acute ischemic stroke in the anterior circulation. This prospective, multicenter, open-label, randomized controlled trial aims to verify the effectiveness and safety of adding albumin to the current standard endovascular treatment for this type of stroke. The study is sponsored by Capital Medical University and focuses on patients aged 18 to 80 years with specific stroke characteristics. Participants are randomly assigned to one of two groups one receiving albumin combined with endovascular treatment and the other receiving endovascular treatment alone. Albumin is given intravenously at a dose of 0.5 gkg up to 37.5 g on the first day and then daily on the second, third, and fourth days. Both groups receive acute stroke care and secondary prevention according to American stroke guidelines. Initial assessments include CT or MRI scans to locate the stroke and rule out bleeding, along with neurological and functional scoring. Throughout the study, patients undergo various evaluations such as the National Institutes of Health Stroke Scale NIHSS, Modified Rankin Scale mRS, Alberta Stroke Program Early CT Score ASPECTS, and quality of life assessments using standardized questionnaires. Vital signs and laboratory tests are monitored at baseline, with a 90-day follow-up conducted by telephone to assess recovery and outcomes. The primary measure is the proportion of patients achieving good functional recovery at 90 days after treatment.

Researchers are conducting a Phase 1b clinical trial to study anisodine hydrobromide in patients who have acute ischemic stroke and are undergoing endovascular therapy. The main goals are to assess the safety and tolerability of the drug and to find the appropriate dose for future studies. This open-label, non-randomized trial uses a dose-escalation design to identify the maximum tolerated dose and recommended dose for Phase II trials. Participants receive anisodine hydrobromide intravenously at one of four dose levels 1.0 mg, 1.5 mg, 2.0 mg, or 2.5 mg twice daily for seven consecutive days alongside standard endovascular therapy. The first dose is given before vascular recanalization but must not delay the endovascular procedure. The drug is diluted in sodium chloride solution and infused over about 60 minutes. All participants also receive standard care for stroke, including mechanical thrombectomy and other procedures as needed. Throughout the study, participants are closely monitored for safety and neurological outcomes. Researchers will measure safety events within eight days of the first dose, neurological changes within 24 hours, stroke infarct volume at day 8, and functional recovery at day 90 using the modified Rankin Scale. Additional assessments include brain hemorrhage events and all-cause mortality within 90 days. The total participation duration extends to approximately three months to capture these outcomes and ensure safety monitoring.

Researchers are conducting a nationwide, multicenter observational study to establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. The study will include patients with respiratory syndrome from various hospital settings across seven regions in China. It aims to monitor pathogen trends, support risk assessment, and provide evidence for prevention and control strategies over several years. Participants diagnosed with respiratory syndrome will have clinical data collected every two weeks, including demographics, symptoms, diagnoses, lab tests, medications, oxygen therapy, hospital stays, ICU admissions, and outcomes. For those meeting specific diagnostic criteria, respiratory and other biospecimens will undergo a range of tests including routine pathogen tests, multiplex PCR, targeted and metagenomic sequencing, antibody and cytokine testing, and exploratory multi-omics analyses. During the study, data and specimens will be collected routinely from participants receiving clinical care. Researchers will generate national and regional surveillance reports to support early warnings and prevention efforts. The main outcomes measured include detection rates and types of respiratory pathogens and immune responses after infection or vaccination, tracked over three years. Participation involves regular data reporting through secure channels without additional treatment interventions.

Researchers are evaluating the safety and immune response of a 24-valent pneumococcal polysaccharide conjugate vaccine CRM197tetanus toxoid in individuals aged 2 months minimum 6 weeks and older. This clinical trial includes Phase I and Phase II parts, with participants divided into various age groups. The study uses randomized, blinded, and dose-escalation designs with positive controls to understand how the vaccine performs across ages from infants to older adults. The trial involves multiple vaccine doses and dose levels low, medium, high depending on age group and phase. Infants receive a primary vaccination series of three doses spaced two months apart, plus a booster dose between 12 and 15 months. Older children and adults receive one dose of the study vaccine or comparator vaccines, with random assignment to different dose groups. The study evaluates several vaccine types, including PCV24 at various doses, PPV23, and PCV13. Participants undergo screening and vaccination visits, with monitoring for adverse reactions within 7 and 30 days after each dose. Blood tests and urinalysis are performed shortly after vaccination to assess safety. Researchers measure immune responses by analyzing pneumococcal antibody levels at multiple time points, including after the primary series and booster doses. The study includes follow-up for serious adverse events up to 180 days after vaccination. Total participation duration varies by age group and dose schedule.

Researchers are evaluating the safety and immune response of a combined vaccine that includes components for Diphtheria, Tetanus, Acellular Pertussis, Haemophilus influenzae type b, and Meningococcal group ACYW135 in children aged 2 months to 6 years. This Phase I clinical trial includes two parts Part One uses a randomized, partially blinded, dose-escalation and partially active-controlled design, while Part Two is a randomized, blinded, placebo-controlled study focusing on 2-month-old participants. The study involves multiple vaccine dosing schedules depending on the participants age group. Some groups receive a single dose of the combined vaccine on Day 0, while others receive three doses at 0, 2, and 4 months, followed by a booster dose between 18 and 24 months of age. The trial compares different dose levels, age groups, and also includes active comparator vaccines and placebo groups. Participants will undergo monitoring for adverse reactions within 14 days after each dose, with additional safety assessments extending up to 180 days for serious events. Researchers will evaluate immune responses by measuring specific antibodies against meningococcal groups and other vaccine components at various timepoints, including before and after booster doses. The total participation duration and detailed follow-up visits are designed to assess both safety and immunogenicity comprehensively.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating the efficacy and safety of oral minocycline in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of onset. This prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial aims to improve patient outcomes and explore the effects of minocycline on venous neuroinflammation in this condition. Participants will be randomly assigned to receive either minocycline or a matching placebo for 5 days alongside standard medical care. The minocycline group will take an initial dose of 200 mg immediately after randomization, followed by 100 mg every 12 hours for a total of 10 doses. Those with swallowing difficulties may receive the medication through a nasal feeding tube. The trial includes screening, treatment, and follow-up phases with visits scheduled at screening, 72 hours, 7 days, 90 days, and 180 days after randomization. During the study, participants will undergo assessments including neurological evaluations and imaging at specified time points. Researchers will measure outcomes such as the modified Rankin Scale score at 90 days, changes in neurological scores, inflammation markers, and stroke recurrence. Safety and efficacy will be monitored through these evaluations, with total participation lasting up to 180 days post-randomization.

Researchers are studying the effects and safety of SR1375 in hospitalized adults with community-acquired pneumonia CAP. This phase 2, randomized, double-blind, placebo-controlled study aims to evaluate SR1375 compared to placebo in patients who have not improved after initial standard pneumonia treatment. The study includes adults aged 18 to 85 years and is sponsored by Shanghai SIMR Biotechnology Co., Ltd. Participants will be randomly assigned to one of four groups to receive either 0.3 mg, 1 mg, or 3 mg of SR1375 capsules or a placebo daily by mouth for 8 weeks, alongside their usual pneumonia treatments. The study includes a screening period, an 8-week double-blind treatment period, and a 14-day safety follow-up after treatment ends. During the study, participants will undergo assessments including the NIAID-OS 8-point scale to monitor pneumonia severity, oxygen levels, and other health measures up to 56 days. Researchers will track outcomes such as oxygenation, mortality, hospitalization duration, and readmission rates. The total participation time for each patient is up to 10 weeks, with close monitoring of safety and health status throughout the study.

Researchers are conducting a multicenter, prospective observational study to investigate how often patients with Helicobacter pylori infection experience dyspeptic symptoms, such as indigestion. The study also aims to follow these patients after they undergo treatment to eradicate H. pylori to see how their dyspeptic symptoms improve over time. This research intends to guide better diagnosis and treatment strategies for patients with H. pylori infection and related digestive discomfort. Participants diagnosed with H. pylori infection confirmed by breath tests or gastroscopy will complete an epidemiological questionnaire and a Functional Dyspepsia Symptom Diary FDSD to record their symptoms. Patients who have dyspepsia and successfully clear the infection will be followed up at 2 months and again at 6 months to assess if their symptoms have improved. The study does not involve any experimental drugs or treatments but focuses on observation and symptom tracking. During the study, patients will provide basic health information and record their digestive symptoms in the diary. Researchers will track the occurrence of dyspepsia at the start and monitor symptom relief after treatment. The follow-up periods at 2 and 6 months after eradication therapy will help measure symptom changes. Participants may be involved for several months, contributing to a better understanding of the natural history of H. pylori-related dyspepsia and treatment outcomes.