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CTRI Number  CTRI/2024/04/065599 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of HYDRODENG SACHET in Dengue fever patients 
Scientific Title of Study   A Randomized, Open label, parallel group, Comparative clinical study to evaluate the efficacy and safety of HYDRODENG SACHET with Cariprill in Dengue fever. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DENGUE/01/24 Version: 1.1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sakthi Balan MD  
Designation  Consultant and CI  
Affiliation  Ki3 Private Limited 
Address  Room 1, Medicine OPD, Thirumalai Medical Centre, Cuddalore main road, Pondicherry Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai Pondicherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan MD  
Designation  Consultant and CI  
Affiliation  Ki3 Private Limited 
Address  Room 1, Medicine OPD, Thirumalai Medical Centre, Cuddalore main road, Pondicherry Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai Pondicherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar  
Designation  Director 
Affiliation  Ki3 Private Limited 
Address  Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai

Chennai
TAMIL NADU
600032
India 
Phone  9003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
Tirupati Medicare Limited, India.AmbalaPaonta Sahib Dehradun Rd Pataliyon Himachal Pradesh 173021  
 
Primary Sponsor  
Name  Tirupati Medicare Limited, India. 
Address  AmbalaPaonta Sahib Dehradun Rd Pataliyon Himachal Pradesh 173021  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakthi Balan  Thirumalai Medical Centre  Room 1, Medicine OPD, Thirumalai Medical Centre, Cuddalore main road, Pondicherry
Pondicherry
PONDICHERRY 		 09443627722

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethique De La Nature Association  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A90||Dengue fever [classical dengue],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HYDRODENG SACHET 100 mg  Orally. One sachet thrice daily – For 7 - 10 days 
Comparator Agent  Tab. Cariprill 1100 mg  Thrice daily orally for 7-10 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Proper written informed consent obtained from the patient before any
procedure performed.
2. Males and females between the age of 18-75 years with an oral temperature of
more than 38.0°C (100.4°F). with or without associated rash, body pain and joint
pain, severe headache especially behind the eyes, nausea and vomiting.
3. Patients having confirmed Dengue Viral fever (Positive NS1 antigen card
test) with thrombocytopenia, with a platelet count between 50,000 /micro
litre to150,000/micro litre.
4. Subjects with stable vitals like pulse and blood pressure
5. Patient should have not participated in any other clinical trial during the past 3
months. 
 
ExclusionCriteria 
Details  1. Patients with Dengue hemorrhagic fever grade III and IV
2. Patients with platelet count less than 50,000/micro litre.
3. Pregnant or lactating women
4. Patients who have received blood or blood products transfusion during the
current illness
5. Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia
6. Patients who have a serum ALT level 3 times higher than the upper limit
of the normal range(greater than 165 U/L),
7. Impaired renal function with serum creatinine greater than 1.5 mg/dl ( males) and greater than 1.4 mg/dl(females),
8. Hypersensitivity to any of the components of the formulation,
9. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
a)Assessment of efficacy parameters, namely platelet count, bleeding time, clotting
time, hematocrit– baseline & on each day, from day 1 to day 3 and on days 5, 7 and
10. Electrolytes and hydration status will be assessed on baseline and post study.
b)Assessment of clinical parameters namely temperature, fever score, arthralgia,
myalgia, headache and loss of appetite - baseline and on day 1 to day 3 and on days
5, 7 and 10. 		 baseline, day 1 to day 3, days
5, 7 and 10. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor for any adverse events during the study period and assess the quality
of life using a pre-and post-feedback questionnaire.
All the outcome parameter will be compared between the test and comparator. 		 Day 0 and day 10 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/04/2024 
Date of Study Completion (India) 13/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 50 participants diagnosed with Dengue viral fever with or without

thrombocytopenia will be enrolled in this study in two separate arms.

The IP will be administered orally thrice daily for 7- 10 days.

The following parameters will be monitored.

a) Assessment of efficacy parameters, namely platelet count, bleeding time, clotting time, hematocrit– baseline & on each day, from day 1 to day 3 and on days 5, 7 and 10. Electrolytes and hydration status will be assessed on baseline and post study.

b) Assessment of clinical parameters namely temperature, fever score, arthralgia, myalgia, headache and loss of appetite - baseline and on day 1 to day 3 and on days 5, 7 and 10.

 
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