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临床试验/CTRI/2024/09/073657
CTRI/2024/09/073657已完成3 期

To check efficacy of guava juice in thrombocytopenia patients induced by dengue fever or any other viral fever

Vishwaraj Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
100
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
12.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Confirmed diagnosis of thrombocytopenia (low platelet count) with dengue fever or any other viral fever.

排除标准

  • Those who are allergic to guava fruit.

结局指标

主要结局

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

时间窗: 2 weeks

次要结局

  • To check symptomatic relief which is induced by dengue fever or any other viral fever(2 weeks)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Swati Khartode

Vishwaraj Hospital

研究点 (1)

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