Health Condition 1: D696- Thrombocytopenia, unspecified
Conditions
Interventions
Intervention1: Dengilux Capsule: Haldi crude powder
Papaya leaf extract
Guduchi extract
Wheatgrass extract
Saffron flower powder
Neem extract
Haldi extract (curcuminoids)
L-Arginine
L-Tyrosine
Cystein
Sponsors
Piramal Retail Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age and Sex: Male and female patients aged between 18 to 65 years. 2. 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. b. Positive Dengue IgM antibodies. 3. Platelet Count: Platelet count must be above 50,000 & less than 1,50,000/ L. 4. 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, 2. 5. 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. 6. Informed Consent: Patients must be willing and able to provide informed consent and comply with the study protocol. 7. 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.
Exclusion criteria
Exclusion criteria: 1. 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. 2. Patients infected with typhoid along with dengue should treat with typhoid antibiotic along with dengue medicine. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. Bleeding Disorders: Patients with known bleeding disorders (e.g., hemophilia, von Willebrand disease), end-stage renal disease, or liver cirrhosis, as these conditions may exacerbate thrombocytopenia or bleeding risk. 10. 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. 11. Pregnancy: Pregnant women or breastfeeding women, as there is insufficient safety data for the use of the Dengilux Capsuley during pregnancy or lactation. 12. Hypersensitivity to Herbal Ingredients: Patients with a history of hypersensitivity or allergic reactions to any ingredients of the Dengilux Capsule being studied. 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Baseline Day (0), Day 3, Day 5 & Day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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] 3. Hematocrit (Hct) levels [Assessed at Days 3, 5, and 15] 4. Liver function enzymes: AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) [Baseline to Day 5 and Day 15] 5. Inflammatory markers: Interleukin-6 (IL-6) cytokine assay, C-reactive protein (CRP) - Quantitative [Baseline to Day 5 and Day 15] 6. Coagulation parameters: Prothrombin Time (PT), International Normalized Ratio (INR), Fibrinogen levels [Baseline to Day 5 and Day 15] Timepoint: 1. IPF and A-IPN on Days 3 ( 1), 5 ( 1), 15 ( 3) 2. Hematocrit, WBC on Days 3 ( 1), 5 ( 1), 15 (d 3. AST/ALT on Days 3 ( 1), 5 ( 1), 15 ( 3).. 4. CRP, IL-6 on Days 3 ( 1), 5 ( 1), 15 ( 3). 5. PT, INR, fibrinogen on Days. Days 3 ( 1), 5 ( : 6. Exploratory: Dengue IgG and anti-NSl IgG on 90 ( 5); optional Day 180 per amendment. | — |
Countries
India
Contacts
Public ContactDurvesh Sawant
Integrity Healthcare Services
Outcome results
None listed