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CTRI Number  CTRI/2024/09/073657 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 16/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Guava juice is the best nutritional supplement in dengue fever or any other fever  
Scientific Title of Study   To check efficacy of guava juice in thrombocytopenia patients induced by dengue fever or any other viral 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 Swati Khartode 
Designation  Consultant Dietitian 
Affiliation  Vishwaraj Hospital 
Address  OPD NO 4,Ground Floor Dietetics and Nutrition Department, Vishwaraj Hospital Near Loni Station, Next to Hadapsar, Pune Solapur Highway

Pune
MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khartode 
Designation  Consultant Dietitian 
Affiliation  Vishwaraj Hospital 
Address  OPD NO 4,Ground Floor, Dietetics and Nutrition DepartmentDietetics and Nutrition Department, Vishwaraj Hospital Near Loni Station, Next to Hadapsar, Pune Solapur Highway


MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khartode 
Designation  Consultant Dietitian 
Affiliation  Vishwaraj Hospital 
Address  OPD NO 4,Ground Floor, Dietetics and Nutrition Department, Vishwaraj Hospital Near Loni Station, Next to Hadapsar, Pune Solapur Highway


MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Source of Monetary or Material Support  
Vishwaraj Hospital Near Loni Station, Next to Hadapsar, Pune Solapur Highway, Maharashtra, India 412201 
 
Primary Sponsor  
Name  Vishwaraj Hospital 
Address  Near Loni Station, Next to Hadapsar, Pune Solapur Highway Pin 412201  
Type of Sponsor  Private hospital/clinic 
 
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 Swati Khartode  Vishwaraj Hospital  OPD no 4 ground floor and all IPD floors, Department of Dietetics and Nutrition, Near Loni Station, Next to Hadapsar, Pune Solapur Highway Pin 412201
Pune
MAHARASHTRA 
9767133699

opd@vrhpune.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERR’s Vishwaraj Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B349||Viral infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guava fruit Juice 100 ml once a day for 2 weeks  Guava fruit Juice 100 ml once a day or twice a day depends on weight for 2 weeks  
Comparator Agent  NIL  NIL There is no any placebo or intervention drink/juice for control group, its just a control group who will not recieve any guava juice or placebo 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Confirmed diagnosis of thrombocytopenia (low platelet count) with dengue fever or any other viral fever.

 
 
ExclusionCriteria 
Details  Those who are allergic to guava fruit 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To check efficacy of guava juice in thrombocytopenia patients, how many days required to increase in paltelet count after taking this guava juice compared to control group   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To check symptomatic relief which is induced by dengue fever or any other viral fever  2 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/09/2024 
Date of Study Completion (India) 01/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
International Journal Of Scientific Research 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dengue virus, a member of the flaviviridae family, is transmitted principally by the Aedes aegypti mosquito. Dengue, an emerging disease of global importance, is characterized by four antigenically related serotypes (Dengue 1–4), where infection with one serotype provides life-long immunity to that dengue serotype but not to other serotypes. Dengue results in a spectrum of clinical presentations, from subclinical infection to severe hemorrhagic disease. Dengue fever, which is usually benign and self-limiting, is characterized by sudden onset of high fever, chills, severe headache (mostly frontal or retro-ocular), skin rash and general malaise. Two distinct clinical entities, dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), have been associated with poorer outcomes, with mortality rates approaching 5% (Seet, R. C., Quek, A. M., & Lim, E. C. (2007).

According to the World Health Organization (WHO) approximately 2.5 billion people, or two-fifths of the world’s population, are now at risk from dengue. The disease is now endemic in over 100 countries. Dengue hemorrhagic fever is a leading cause of serious illness and death among children in some Asian countries. (Mishra, S., Agrahari, K., & Shah, D. K. (2017).

A symptomatic episode usually comprises a febrile phase (with fever of at least 38.5°C), a critical phase around defervescence (which may include hemorrhagic manifestations and/or dengue shock syndrome), and a recovery or convalescent phase. However, some dengue patients present persistent symptoms including fatigue, depression, and weight loss after the recovery phase, a possibility acknowledged by the World Health Organization (WHO) since 1997 (Tiga, D. C., Undurraga, et al. (2016). Also dengue virus results in a spectrum of ocular manifestations, ranging from non-specific symptoms to severe retinal hemorrhages. (Seet, R. C., Quek, A. M., & Lim, E. C. (2007).

In dengue fever intake of proper diet with liquids results in better nutritional status, increased appetite and balance electrolytes. Diet therapy is very helpful in recovering from dengue, good nutritional status, increased appetite and increase RBC count and balanced electrolytes. (Mishra, S., Agrahari, K., & Shah, D. K. (2017).

A retrospective study was carried out for a period of 6 months from November 2017 to April 2018 with the objective to analyze the effect of vitamin C in the management of Dengue fever in the tertiary care hospitals of selected three states of India (Tamil Nadu, Kerala, and Madhya Pradesh), the patients who were administered with Vitamin C had a greater percentage increase in their platelet count and a shorter duration of hospital stay. Study indicates that there exists an association between Vitamin C intake and length of hospital stay (Ramalingam, K.,et al.(2019).

 

In current study we will check efficacy of Guava juice, in this guava juice 10 % Amla (Indian gooseberry) has been added to enhance the action of guava and for better absorption of juice. We will make two groups of thrombocytopenia (low platelet count) caused by dengue fever or any other viral fever, one group will be received this guava juice and other group, control group will not be received Guava juice. Then we will check which group’s platelet count will be increased.  Both groups will receive same diet chart, same treatment, same nutritional supplements if any, but the difference is only one group will be received guava juice and other group will not be received guava juice.       
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