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CTRI Number  CTRI/2024/10/076100 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 18/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Evaluate The Efficacy Of Hriberadi Paneeya(A Classical Ayurvedic Formulation) In Dengue Fever 
Scientific Title of Study   An Open-Label Clinical Trial To Evaluate The Efficacy Of Hriberadi Paneeya (A Classical Ayurvedic Formulation) As Adjuvant Therapy In Management Of Dengue Fever 
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 Veena JIgalur 
Designation  Associate Professor and HOD 
Affiliation  Ragiv Gandhi University Of Health Sciences Bengaluru 
Address  Dept of Koumarabhutya Shri Hingulambika Ayurvedic Medical College and Hospital Kalaburagi Karnataka

Gulbarga
KARNATAKA
585106
India 
Phone  9902475794  
Fax    
Email  veenajigalur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh Deole 
Designation  Proffesor 
Affiliation  Charutar Vidya Mandal University Anand Gujarat 
Address  Dept Of Kayachikitsa G J Patel institute of Ayurvedic studies and Research New Vallabh Vidya Nagar Anand Gujrat

Anand
GUJARAT
388120
India 
Phone  9974999309  
Fax    
Email  yogesh.deole@cvmu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Yogesh Deole 
Designation  Professor 
Affiliation  Charutar Vidya Mandal University Anand Gujarat 
Address  Dept Of Kayachikitsa G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidya Nagar Anand Gujrat

Anand
GUJARAT
388120
India 
Phone  9974999309  
Fax    
Email  yogesh.deole@cvmu.edu.in  
 
Source of Monetary or Material Support  
Sujani Mother and Child care Hospital Opposite Big Bazar-STBT-Dargah Road Kalaburagi-585105 Karnataka 
 
Primary Sponsor  
Name  Dr Veena Jigalur 
Address  PhD Scholar Dept Of Kayachikitsa G J Patel Institute of Ayurveda Studies and Research Ananad - 388120 Gujarat 
Type of Sponsor  Other [Self] 
 
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 Veena Jigalur  Sujani Mother and Child Care Hospital  OPD NO 1 Paediatric OPD opp.Big Bazar-STBT-Dargah Road Kalaburagi-585105 KARNATAKA
Gulbarga
KARNATAKA 
09902475794

veenajigalur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G J Patel Institute of Ayurvedic Studies and Research Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:3||Administration. Ayurveda Condition: PAITTIKAJVARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Hriberadi Paneeya, Reference: Charaka samhita chikitsa sthana 4/31, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 100(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -no
2Comparator Arm (Non Ayurveda)-Sujani Mother and Child care HospitalSujani Mother and Child care Hospital Kalaburagi Karnataka
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  History of acute onset of fever 24 hrs to 48 hrs, Patients with Dengue NS1 positive Dengue IgM positive and Dengue IgM weekly Positive 
 
ExclusionCriteria 
Details  1) Patients with Dengue IgM positive(Treated on OPD basis)
2) Mentally retarded patients
3) Patients below 8Years and above 18 years of age
4) All chronic fevers of more than 21 days
5) patient entering shock will be excluded(dropped)
6)Patients with platelet count below 20000 will be excluded(dropped) 
 
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 
Dengue patients with Hriberadi Paneeya recover fast  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Dengue patients with Hriberadi Paneeya will not have recrudescence   14 days 
Dengue patients with Hriberadi Paneeya will not progress to complications  7 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   20/01/2025 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

INTRODUCTION:

Dengue is a fast emerging, outbreak-prone and mosquito-borne viral fever. The incidence of Dengue is increasing in recent years with repeated outbreaks from many States and newer areas. At present, except Ladakh all the States and Union Territories are reporting Dengue cases1

Dengue is viral infection transmitted by mosquitoes. Dengue viruses are flaviviruses related to yellow fever virus and Japanese encephalitis virus. There are four serotypes, infection with one serotype does not induce solid immunity to the others, and individuals may suffer from dengue more than once. 2 Transmission is by day-biting of Aedes aegypti mosquitoes. It is not transmitted directly between humans.

Ayurvedic view

Jwara is the most common independent disease entity. It can also be found as a symptom of several other diseases too. Jwara deserves to be described first being the foremost of all Somatic diseases. It is also recognized as the most important cause of death.3It is a condition in which the Santapa (rise of temperature), Swedavarodha (obstruction to perspiration) and angamarda (pain all over the body) exists simultaneously.4, 5

In Ayurveda, Madhavakara explained dandaka jwara which merely matches with another name of dengue i.e. breakbone fever but symptoms do not match other than severe body ache.5

            Charakacharya in nidanastana explained about Pittaja jwara6 which indicate the dengue fever, and pitta Pradhana kaphavaata heena jwara7 explained in chikitsa sthana clearly denote the complication or late stage of dengue i.e, dengue hemorrhagic fever and dengue shock syndrome. Hence pittaja jwara and pitta Pradhana kaphavaata heena jwar are the stages in dengue fever

ORIGIN OF THE RESEARCH PROBLEM:

        Amid climate change, vector borne diseases are spreading at increased rates across larger areas, Dengue is the most rapidly spreading mosquito born viral illness. Dengue, the sometimes fatal, painful viral infection has been spiking in many parts of India in recent years with the West Bengal, Kerala, Karnataka, and Maharashtra particularly hard hit.

                   In 2023, India officially recorded 289235 cases and 485 deaths. In 2024, 19447 cases reported and 16 deaths till 21st February 20241

             From 2005 to 2024 many research works were done on Dengue in Ayurveda but remarkably many researches are carried after 2019, post COVID-19. Many of researches were focusing mainly Platelet count fall and immune boost. Even case studies were done on Dengue with drugs like Tulsi, Amruta, Amalaki, and Triphala but studies to aim Dengue fever and to prevent its complication Dengue hemorrhagic fever not conducted with large sample size.

                The preparation Hriberadi Paneeya8 has Musta, Parpataka, Ushira, Chandana, and Hribera, all these drugs have tikta rasa and sheeta veerya which help to treat Jwara at the same time will help to prevent complications of Dengue.

DEFINITION OF THE RESEARCH PROBLEM:

     This research study emphasizes providing an adjuvant therapy through Ayurveda to manage Dengue Fever and prevent its complications. The classical herbal formulation ‘Hriberadi Paneeya’ has not been evaluated in any research studies for its effectiveness in Dengue and can provide a better option for management.

RESEARCH GAP/REVIEW OF LITERATURE:

               Charakacharya in nidanastana explained about Pittaja jwara6 which indicate the dengue fever, and Pitta Pradhana kaphavaata heena jwara7 explained in chikitsa sthana clearly denote the complication or late stage of dengue i.e, dengue hemorrhagic fever and dengue shock syndrome. Hence pittaja jwara and pitta Pradhana kaphavaata heena jwar are the stages in dengue fever.

             In Ayurveda very few studies are conducted on Dengue fever and most of them are focusing on platelet count with the intervention of Eranda karkati (carica papaya) patra swarasa. No study focused on preventing the complications. The Hriberadi Paneeya mentioned in Charaka Samhita Chikitsa sthana, no studies are conducted which helps in treating Dengue fever and preventing its complications as well.

METHODOLOGY

Study design    - An Open - Label Randomized Controlled Clinical Trial

Sample source - 1) Shri Hingulambika Education Society’s Ayurvedic Medical College and     

                                Hospital, Kalaburagi, Karnataka.

                            2) Sujani Mother and Child Care Hospital, Kalaburagi, Karnataka

Sample size - 40 patient in each group (Mann Whitney U Test is used to calculate the sample size)

 GROUPING AND RESEARCH DESIGN

Groups and sample size

Intervention

A (50)

Contemporary medical management

B (50)

Contemporary medical management except IV fluids along with Hriberadi paneeya as adjuvant therapy

DURATION: The clinical trial will last for 7 days

FOLLOW UP:  After 7 days (14th day)

DELIVERABLES / OUTCOMES:

Dengue patients with Hriberadi paneeya recover fast

Dengue patients with Hriberadi paneeya will not have recrudescence

Dengue patients with Hriberadi paneeya will not progress to complication

                                                                                                    (DHF, DSS)

REFERENCES:

1)https://www.indiatoday.in/health/story/how-rising-dengue-burden-is-costing-india-and-sri-lanka-billions-2516716-2024-03-19

2) https://www.who.int/emergencies/disease-outbreak-news/item/2024-DON518

3)https://ncvbdc.mohfw.gov.in/index4.php?lang=1&level=0&linkid=431&lid=3715

4)https://m.economictimes.com/magazines/panache/dengue-risk-re-evaluated-india-research-finds-first-infections-can-be-as-severe-as-secondary/articleshow/108384055.cms

5)Sharma A, jain A, jain bhadora S. Kayachikitsa. Vol. 2. Delhi: Choukhamba orientalia; 2018.p.470

6)Agnivesha, Charaka samhita, Nidanasthana Chapter 1st, Shloka 16.  Gangasahaya Pandeya editor, 8th ed. Varanasi: Chaukhambha Bharati Academy; Reprint2004.p.473.

7)Agnivesha, Charaka samhita, Chikitsasthana, Chapter 3, Shloka 4. DR.Bramhanand TRipathi editor. Varanasi: Chaukhambha Sanskrit Sansthan; 4th edition; 1994. p.112.

8)Agnivesha, Charaka samhita, Chikitsasthana, Chapter 4, Shloka 31. Dr.Brahmanand Tripathi editor. Varanasi: Chaukhambha Sanskrit Sansthan; 4th edition; 1994.  p. 226.

 

 

 
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