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
|
|
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
|
|
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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