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CTRI Number  CTRI/2025/10/095771 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical
Other (Specify) [Food Supplement (FSSAI)]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Dengilux plus standard dengue treatment vs placebo in adults with mild–moderate dengue and low platelets: to study the effect on platelet count over 5 days and safety. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anirudh Tripathi 
Designation  Principal Investigator 
Affiliation  Life Veda Treatment and Research Center 
Address  Lifeveda Treatment and Research Center, 7/6 Century Quarters, Near Doordarshan TV Tower, P.B. Road, Worli,

Mumbai
MAHARASHTRA
400018
India 
Phone  9820180081  
Fax    
Email  dranirudh_t@yahoo.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Aasin Maurya  
Designation  Medical Writer  
Affiliation  Integrity Healthcare Services  
Address  Integrity Healthcare Services, Clinical Research Department 1-5, Shreeji Arcade 2nd floor, Dr Almeida Road, Panchapakhadi, Thane (West)

Thane
MAHARASHTRA
400602
India 
Phone  9821471425  
Fax    
Email  amaurya@ihsindia.com   
 
Details of Contact Person
Public Query  
Name  Durvesh Sawant 
Designation  Clinical Research Associate 
Affiliation  Integrity Healthcare Services  
Address  Integrity Healthcare Services, Clinical Research Department 1-5, Shreeji Arcade 2nd floor, Dr Almeida Road, Panchapakhadi, Thane (West)

Thane
MAHARASHTRA
400602
India 
Phone  8828152776  
Fax    
Email  durvesh@ihsindia.com  
 
Source of Monetary or Material Support  
Piramal Retail Private Limited. Piramal Tower, 1st Floor, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, INDIA , 400013 
 
Primary Sponsor  
Name  Piramal Retail Private Limited  
Address  Piramal Tower, 1st Floor, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, INDIA , 400013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Talekar  Anupama Polyclinic  Anupama Polyclinic, 7/1/2, K.K. Estate. Modi Chawl, T.J.Road, Opp Dosti Flamingo Gate No.2, Sewri(West)
Mumbai
MAHARASHTRA 		 9323153191

drmaheishtalekar1978@gmail.com 
Dr Anirudh Tripathi  Life Veda Treatment and Research Center  LifeVeda Treatment and Research Center: 7/6 Century Quarters, Near Doordarshan TV Tower, P.B. Road, Worli,
Mumbai
MAHARASHTRA 		 9820180081

dranirudh_t@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Independent Ethics Committee CIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D696||Thrombocytopenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dengilux Capsule  Haldi crude powder Papaya leaf extract Guduchi extract Wheatgrass extract Saffron flower powder Neem extract Haldi extract (curcuminoids) L-Arginine L-Tyrosine Cysteine / N-acetylcysteine 1 Capsule thrice a day administered for 5 days with standard supportive care for dengue  
Comparator Agent  Placebo Capsule  1 Capsule thrice a day administered for 5 days with standard supportive care for dengue 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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/µL.
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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  Baseline Day (0), Day 3, Day 5 & Day 15. 
 
Secondary Outcome  
Outcome  TimePoints 
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]
 		 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.
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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). 
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