Phase II Double Blind Randomized Controlled Clinical Trial for the Investigation of the Efficacy and Safety of Dengilux Capsule for Thrombocytopenia in mild to moderate Dengue Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean change in platelet count from baseline (Day 0) to End-of-Treatment Day 5 (±1), measured by automated hematology analyzer; analysis ITT with supportive PP.
研究概览
简要总结
This multicenter, Phase II, randomized (1:1), double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of Dengilux® capsules as add-on therapy to standard care in adults aged 18–65 years with mild to moderate dengue and thrombocytopenia. Participants will receive Dengilux 450 mg orally three times daily for 5 days or a matching placebo for 5 days; both arms continue standard care. Randomization will be centrally generated with allocation concealment, and participants, site staff, and outcome assessors will remain blinded. The primary endpoint is the mean change in platelet count from baseline (Day 0) to end-of-treatment Day 5 (±1), measured on an automated hematology analyzer; the primary analysis set is intention-to-treat with a supportive per-protocol analysis. Secondary outcomes include immature platelet fraction and absolute immature platelet number, hematocrit and white blood cell count, coagulation parameters (PT/INR, fibrinogen), inflammatory markers (CRP, IL-6), and hepatic/renal safety labs (AST, ALT, BUN, creatinine), assessed at prespecified visits [Days 3 (±1), 5 (±1), and 15 (±3); baseline to Day 5 and Day 15 for laboratory safety and inflammation]. Patient-reported outcomes will be captured using a validated Dengue Illness Index. Exploratory outcomes include Dengue IgG and anti-NS1 IgG at Day 90 (±5), with an optional Day-180 assessment per amendment. Participants will be followed through Days 15, 42, 56, and 90 for durability of response and safety. The trial will be conducted using prespecified statistical methods (baseline-adjusted between-group comparisons with 95% confidence intervals).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age and Sex: Male and female patients aged between 18 to 65 years.
- •Laboratory-confirmed Dengue Infection: Patients must demonstrate evidence of a laboratory-confirmed dengue infection, which may be evidenced by one of the following: a.
- •Positive Dengue NS1 Antigen test.
- •Positive Dengue IgM antibodies.
- •Platelet Count: Platelet count must be above 50,000 & less than 1,50,000/µL.
- •Mild to Moderate Dengue Diagnosis: Patients must be diagnosed with mild to moderate dengue fever as per the WHO Dengue Severity Classification as Group A patients.
- •This includes individuals presenting with a combination of clinical signs and laboratory findings consistent with mild to moderate dengue without signs of severe complications such as severe hemorrhage, shock, or organ failure or Hospitalization.
- •These are patients who are able to tolerate adequate volumes of oral fluids and pass urine at least once every six hours, and do not have any of the warning signs, particularly when fever subsides1,
- •Symptomatic Presentation: Patients must present with a variety of dengue symptoms (e.g., fever, rash, fatigue, myalgia, headache) associated with mild to moderate disease severity, without evidence of severe dengue.
- •Informed Consent: Patients must be willing and able to provide informed consent and comply with the study protocol.
- •Precautions: Participants must be willing and able to abstain from consuming sour foods and citrus fruits for a period of seven days from the date of enrollment.
排除标准
- •Severe Dengue or Hospitalization Requirement: Patients requiring hospitalization for management of severe dengue manifestations, such as shock, organ failure, or severe bleeding, will be excluded from the study.
- •Patients infected with typhoid along with dengue should treat with typhoid antibiotic along with dengue medicine.
- •Antiplatelet or Anticoagulant Use: Patients currently on antiplatelet or anticoagulant medications, as these treatments could interfere with the evaluation of platelet count restoration or confound the results.
- •Chronic Liver Disease: Patients with chronic liver disease or those exhibiting elevated AST/ALT levels exceeding 5 times the upper limit of normal (ULN) will be excluded due to the potential for liver dysfunction influencing the study outcomes.
- •Uncontrolled or Serious Comorbidities: Patients with uncontrolled serious comorbidities (e.g., cardiovascular disease, uncontrolled diabetes, etc.) or other conditions that might compromise patient safety or interfere with study participation will be excluded.
- •Idiopathic Thrombocytopenic Purpura (ITP) or Immunosuppressive Therapy: Patients with ITP, or those currently on immunosuppressive therapy for autoimmune disorders or hematologic conditions, will be excluded due to their impaired immune and hematologic function.
- •Participation in Other Clinical Trials: Patients who have participated in other clinical trials within the last 3 months prior to screening, as prior interventions might interfere with the evaluation of study outcomes.
- •Use of Herbal Products: Patients who have used herbal products or supplements within 30 days prior to screening, as these may interfere with the study of Dengilux Capsule.
- •HIV-Positive Patients on Antiviral Therapy: Patients diagnosed with HIV and undergoing antiviral therapy, as this may interfere with the immune modulation pathways or safety monitoring.
- •Pregnancy: Pregnant women or breastfeeding women, as there is insufficient safety data for the use of the Dengilux Capsuley during pregnancy or lactation.
- •Hypersensitivity to Herbal Ingredients: Patients with a history of hypersensitivity or allergic reactions to any ingredients of the Dengilux Capsule being studied.
- •Mild Bleeding (Grade 1): Patients with WHO Grade 1 bleeding, characterized by isolated petechiae without significant clinical implications, will be excluded to focus on patients with moderate to severe manifestations of dengue-associated thrombocytopenia.
结局指标
主要结局
Mean change in platelet count from baseline (Day 0) to End-of-Treatment Day 5 (±1), measured by automated hematology analyzer; analysis ITT with supportive PP.
时间窗: Baseline Day (0), Day 3, Day 5 & Day 15.
次要结局
- 1. Immature Platelet Fraction (IPF) [Assessed at Days 3, 5, and 15](2. Absolute Immature Platelet Number (A-IPN) [Assessed at Days 3, 5, and 15])
研究者
Dr Anirudh Tripathi
Life Veda Treatment and Research Center