Skip to main content
Clinical Trials/CTRI/2022/07/043922
CTRI/2022/07/043922
Completed
Not Applicable

A comparative study in thrombocytopenia induced by dengue fever or viral fever between kiwi and guava - A Randomized Clinical Trial

Not provided2 sites in 1 country40 target enrollmentStarted: July 13, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Increase count of platelet

Overview

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 ofthrombocytopenia (low platelet count) caused by dengue fever or any other viralfever, one group will be received kiwi (Chinese gooseberry) and other groupwill be received Amla (Indian gooseberry) and Guava. Then we will check whichgroup’s platelet count will be increased. Both groups will receive same diet chart only one group will be receivedkiwi 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

 â€¢ 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

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
5.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with thrombocytopenia (Low platelet count) induced by dengue fever or any other viral fever.

Exclusion Criteria

  • Patients less than 5 years.

Outcomes

Primary Outcomes

Increase count of platelet

Time Frame: 2-3 WEEKS

Secondary Outcomes

  • Symptomatic relief(2-3 weeks)

Investigators

Sponsor
Not provided

Study Sites (2)

Loading locations...

Similar Trials