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CTRI Number  CTRI/2022/07/043922 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical
Other (Specify) [Food and Diet intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
Which is better in viral fever? kiwi or guava 
Scientific Title of Study
Modification(s)  
A comparative study in thrombocytopenia induced by dengue fever or viral fever between kiwi and guava - A Randomized Clinical Trial 
Trial Acronym   
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  A-2/38, Ved vihar society, Near Noble hospital, Magarpatta road, Hadapsar
Loni Kalbhor, Pune-Solapur highway
Pune
MAHARASHTRA
411028
India 
Phone  9767133699  
Fax    
Email  khartode.swati@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khartode 
Designation  Consultant Dietitian  
Affiliation  Vishwaraj Hospital 
Address  A-2/38, Ved vihar society, Near Noble hospital, Magarpatta road, Hadapsar
Loni Kalbhor, Pune-Solapur highway
Pune
MAHARASHTRA
411028
India 
Phone  9767133699  
Fax    
Email  khartode.swati@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khartode 
Designation  Consultant Dietitian  
Affiliation  Vishwaraj Hospital 
Address  A-2/38, Ved vihar society, Near Noble hospital, Magarpatta road, Hadapsar
Loni Kalbhor, Pune-Solapur highway
Pune
MAHARASHTRA
411028
India 
Phone  9767133699  
Fax    
Email  khartode.swati@gmail.com  
 
Source of Monetary or Material Support  
Shrigiri Hospital and Heart Care Centre 1st floor Matrusmruti building Opposite to gadital Pune solapur highway hadapsar pune 411028 
Vishwaraj Hospital Near Loni Station, pune solapur highway, next to Hadapsar, kadam wak vasti loni kalbhor Pin number 412201 
 
Primary Sponsor  
Name  NONE 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Swati Khartode  Shrigiri Hospital and Heart Care Centre  OPD and IPD First Floor Shrigiri Hospital Opposite to gadital Hadapsar, Pune
Pune
MAHARASHTRA 
9767133699

khartode.swati@gmail.com 
Dr Swati Khartode  Vishwaraj Hospital  OPD and IPD Ground floor Vishwaraj Hospital Loni kalbhor Pune-Solapur highway
Pune
MAHARASHTRA 
9767133699

khartode.swati@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee of Maeers Vishwaraj Hospital  Approved 
Institutional Ethics Committee of Maeers Vishwaraj Hospital  Approved 
Institutional Ethics Committee of Maeers Vishwaraj Hospital  Approved 
Institutional Ethics Committee of Maeers Vishwaraj Hospital  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], (2) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amla (Indian Gooseberry) or Guava  Second group will be received 100 gm of Amla (Indian Gooseberry) or Guava till platelet count gets normal, it may be 2 weeks to 1 month 
Intervention  Kiwi (Chinese Gooseberry) Fruit  One group will be received 100 gm kiwi (Chinese Gooseberry) fruit till platelet count gets normal, it may be for 2 weeks to 1 month 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with thrombocytopenia (Low platelet count) induced by dengue fever or any other viral fever 
 
ExclusionCriteria 
Details  Patients less than 5 years 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increase count of platelet  2-3 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic relief  2-3 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/07/2022 
Date of Study Completion (India) 30/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published in International Journal of food and Nutrition sciences  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Introduction:-

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 make two groups of thrombocytopenia (low platelet count) caused by dengue fever or any other viral fever, one group will be received kiwi (Chinese gooseberry) and other group will be received Amla (Indian gooseberry) and Guava. Then we will check which group’s platelet count will be increased.  Both groups will receive same diet chart only one group will be received kiwi and other group will be received amla (Indian gooseberry) and guava.      
 
     Study Design:

Interventional / Experimental study with clinical trial to increase the platelet count in dengue fever and other viral fever.

 

 

The schedule of the patient’s visit at study site will be as follows:

Visit 1 (Day 1) –

·       Screening visit which include subject’s detailed medical history, past history, any allergy of food, dietary recall, checking inclusion and exclusion criteria, Educating to subject about Intervention of Kiwi (Chinese gooseberry) and amla (Indian gooseberry) or guava , signature on consent form.

·       Diet chart which included kiwi (Chinese gooseberry) and amla (Indian gooseberry) or guava  will be provided.

 

 

Follow up visit ( Day 2 )

 

TELEPHONIC OR IN PERSON VISIT FOLLOW UP

 

• To confirm whether the recommended dose of  Kiwi (Chinese gooseberry) and Amla (Indian gooseberry) or guava  has been consumed or not? • See the adverse effect, if any

   

 

    WEEKLY TELEPHONIC OR IN PERSON VISIT FOLLOW UP FOR 2 WEEKS

 

·       Weekly follow up for, whether subject taking advised and recommended dose of Kiwi (Chinese gooseberry) and Amla (Indian gooseberry) or guava  as per diet chart provided on day 1 visit.

·       Modification of diet chart, if required.

 

 

 

AT THE END OF 2nd WEEK

Will repeat complete blood count for platelet count 

 

END OF THE STUDY FOLLOW UP


 
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