Effect of Papaya Leaf Extract on Thrombocytopenia in Children With Dengue Fever at a Tertiary Care Center in Karachi
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Platelet Count from Day 1 to Day 3
研究概览
简要总结
The goal of this clinical trial is to evaluate whether Carica papaya leaf extract (CPLE) can improve platelet counts in children aged 2 to 12 years diagnosed with dengue fever and thrombocytopenia. The main questions it aims to answer are:
Does Carica papaya leaf extract significantly increase platelet counts compared to standard supportive therapy alone?
Does the use of Carica papaya leaf extract reduce the need for platelet transfusion or PICU admission?
Researchers will compare the group receiving CPLE plus standard therapy to the group receiving standard therapy alone to see if CPLE leads to improved platelet recovery and better clinical outcomes.
Participants will:
Be randomly assigned to receive either standard care or standard care plus Carica papaya leaf extract syrup (10 mL orally, three times daily for 3 days)
Undergo blood testing on Day 1 and Day 3 to assess platelet count, hemoglobin, WBC, and packed cell volume
Be monitored for clinical outcomes including need for transfusion and admission to the Pediatric Intensive Care Unit (PICU)
详细描述
Dengue fever is a mosquito-borne viral illness that continues to pose a significant health threat in tropical and subtropical regions, including Pakistan. One of the common hematological complications of dengue infection is thrombocytopenia (a low platelet count), which can lead to bleeding, requiring hospitalization, intensive care, or platelet transfusions. Currently, there is no specific antiviral treatment for dengue; management remains largely supportive.
Carica papaya leaf extract (CPLE) has shown potential as an adjunct therapy due to its proposed thrombopoietic, anti-inflammatory, and antiviral properties. Previous studies, primarily conducted in other countries, have suggested that CPLE may aid in increasing platelet counts in patients with dengue fever. However, limited data exists regarding its efficacy in pediatric populations within Pakistan.
This randomized controlled trial will be conducted to evaluate the efficacy of oral Carica papaya leaf extract in improving platelet counts in children with dengue-associated thrombocytopenia. The study will be carried out at the Department of Pediatrics, Ziauddin Hospital, Clifton Campus, Karachi, over a period of three months.
Participants will be randomly assigned into two groups:
Intervention group (n=55): Will receive 10 mL of Carica papaya leaf extract syrup orally three times daily (each 10 mL dose containing 1000 mg of extract) along with standard supportive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with dengue fever
- •Patients from age 2 till 2 years of age
排除标准
- •Patients hypersensitive to papaya leaf extract
- •Patients with bleeding disorder
研究组 & 干预措施
Carica Papaya Leaf Extract Group
Participants in this arm will receive oral Carica papaya leaf extract syrup (10 mL containing 1000 mg of extract), administered three times daily for 3 days, along with standard supportive care for dengue fever. Standard therapy includes hydration, antipyretics, and monitoring per hospital protocol.
干预措施: Carica Papaya Leaf Extract Group (Drug)
Standard Therapy Group
Participants in this arm will receive standard supportive treatment for dengue fever, including antipyretics, fluids, and monitoring as per institutional protocol. No Carica papaya leaf extract will be administered.
干预措施: standard treatment (Other)
结局指标
主要结局
Change in Platelet Count from Day 1 to Day 3
时间窗: Baseline (Day 1) and Day 3
To evaluate the effectiveness of Carica papaya leaf extract in increasing platelet count in pediatric patients with dengue-associated thrombocytopenia
次要结局
未报告次要终点
研究者
Guzel Maxood
Principal Investigator
Ziauddin Hospital