| 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
|
|
|
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
|
|
|
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. |