Sanmenxia

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

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 studying adult patients who have had an acute ischemic stroke caused by blockage in medium-sized brain blood vessels. This trial aims to evaluate the effectiveness and safety of tenecteplase compared to standard medical care in patients treated within 4.5 to 24 hours after stroke symptoms begin. The study focuses on a specific group with confirmed medium vessel occlusions and uses imaging methods to select participants based on brain blood flow and damage. Participants will be randomly assigned to receive either a single intravenous dose of tenecteplase 0.25 mg per kilogram, up to 25 mg or standard medical treatment, which may include aspirin andor clopidogrel, following national stroke care guidelines. Treatments will be given between 4.5 and 24 hours after the patient was last seen well. The trial is controlled, randomized, and open-label with blinded evaluation of outcomes. During the study, participants will be monitored through clinical assessments including the National Institutes of Health Stroke Scale and the modified Rankin scale to measure disability at 90 days. Imaging tests such as CT or MRI perfusion scans will be used to evaluate brain blood flow and damage. Researchers will track neurological improvement, adverse events, bleeding events, and quality of life up to one year after treatment. The main outcome is the proportion of patients achieving minimal disability at 90 days post-treatment.

Researchers are evaluating the long-term effectiveness and safety of drug-coated balloon DCB strategies, including DCB alone or combined with drug-eluting stents DES, compared to DES-only treatment in patients with chronic total occlusion CTO of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed hybrid strategy, or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy DAPT. The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.

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 evaluating ICP-488 in a multicenter, randomized, double-blind, placebo-controlled Phase III study involving Chinese adults with moderate to severe plaque psoriasis. The trial aims to assess the effectiveness, safety, and how the drug moves through the body pharmacokinetics in this patient group. Participants have a history of plaque psoriasis for at least six months and require systemic therapy or phototherapy. Participants will receive either oral ICP-488 tablets or a matching placebo according to the study protocol. The study includes random assignment to one of these two groups, and both participants and researchers are blinded to the treatment allocation. The primary treatment period lasts 16 weeks, with further follow-up extending to 52 weeks to monitor longer-term effects and safety. During the study, participants will undergo regular evaluations including assessments of skin clearance using the static Physicians Global Assessment sPGA and the Psoriasis Area and Severity Index PASI. Researchers will monitor adverse events and measure drug levels and metabolites at various points up to week 52. The study will also track improvements in skin condition and safety through planned visits, ensuring comprehensive observation throughout the trial period.

Researchers are studying the effects of oral ICP-332 in adults with moderate to severe atopic dermatitis, also known as atopic eczema. This randomized, double-blind, placebo-controlled phase III trial aims to evaluate how well ICP-332 works and how safe it is for people suffering from this chronic skin condition. Participants have had atopic dermatitis for at least one year and have not responded adequately to topical treatments or cannot use them for medical reasons. Participants will be randomly assigned to receive either ICP-332 tablets or placebo tablets. Both treatments are given orally as tablets. The study uses a quadruple masking method to keep participants, caregivers, investigators, and outcome assessors unaware of the assigned treatments. The main treatment period lasts 16 weeks, during which researchers will observe the changes in eczema severity and skin condition. During the study, participants will attend scheduled visits to monitor their progress, receive treatments, and undergo laboratory tests and assessments. Researchers will measure outcomes such as the proportion of participants achieving at least a 75% improvement in the Eczema Area and Severity Index and those reaching a skin assessment score indicating clear or almost clear skin. Participants must follow the treatment and visit schedule and agree to contraception if applicable. The total participation period covers the primary 16-week treatment phase and ongoing safety monitoring.

Researchers are evaluating the efficacy and safety of JS107 compared to investigator-selected therapies as second-line or later treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma. The trial focuses on patients whose tumors are positive for CLDN18.2 and negative for HER2, who have already received at least one prior systemic therapy including fluorouracil and platinum. This is a randomized, controlled, open-label Phase III study enrolling about 560 participants. Participants are randomly assigned in equal numbers to either receive JS107 intravenously at 3 mgkg every 21 days or one of three chemotherapy regimens chosen by investigators irinotecan, paclitaxel, or docetaxel. These chemotherapy drugs are administered according to standard doses and schedules over 21- or 28-day cycles, with premedications given as needed. Treatment continues until disease progression, death, withdrawal, or study termination. During the study, participants will be monitored through imaging assessments to measure progression-free survival and overall survival, with other evaluations including response rates and safety outcomes up to two years or more. Tumor tissue testing for CLDN18.2 positivity is required before enrollment. The study also tracks drug concentrations and immune responses to JS107. Participation may last several years, with follow-up visits to assess treatment effects and adverse events under medical supervision.

Researchers are conducting a multicenter, prospective observational study across 200 hospitals in China to examine current treatment patterns for chronic hepatitis B CHB. The study aims to compare patient outcomes under different treatment regimens to provide evidence-based data that can improve CHB treatment strategies and follow-up care, ultimately advancing efforts toward a functional cure for chronic hepatitis B. Participants include those receiving or planned to receive treatments such as entecavir ETV, tenofovir disoproxil fumarate TDF, tenofovir alafenamide fumarate TAF, tenofovir amibufenamide TMF, or peginterferon alpha-2b injection. The study observes real-world clinical practice without assigning treatments, capturing data on these therapies over an extended period. During the study, researchers will monitor outcomes including the percentage of patients developing HBsAg-associated hepatocellular carcinoma HCC, incidence of HCC, rates of HBsAg seroclearance and seroconversion, changes in HBsAg levels, HBV DNA levels, liver fibrosis improvement, and liver-related complications. Data collection spans from week 4 up to week 240, with continuous follow-up to assess treatment effects and patient status over time.