Dengue FeverPhase 2papaya leafNCT07172100
To Assess the Efficacy of Carica Papaya Leaf Extract in Improving Platelet Counts Among Pediatric Patients With Dengue-associated Thrombocytopenia
A Phase 2 study testing Carica Papaya Leaf Extract Group and standard treatment in people with Dengue Fever and Papaya Leaf Extract, run by Ziauddin Hospital at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever, Papaya Leaf Extract, Pediatric Patients
- What is being tested?
- Carica Papaya Leaf Extract Group and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with dengue fever
- Patients from age 2 till 2 years of age
Who cannot join
- Patients hypersensitive to papaya leaf extract
- Patients with bleeding disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Papaya Leaf Extract on Thrombocytopenia in Children With Dengue Fever at a Tertiary Care Center in Karachi
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?
Read more
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)
Read the detailed description
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.
Control group (n=52): Will receive standard supportive therapy alone.
The primary objective of the study is to assess whether CPLE significantly increases platelet counts from Day 1 to Day 3 compared to standard therapy alone. Secondary objectives include evaluating changes in hemoglobin levels, white blood cell (WBC) count, packed cell volume (PCV), need for platelet transfusion, and admissions to the Pediatric Intensive Care Unit (PICU).
Baseline demographics (age, gender, height, and weight) will be recorded. Laboratory tests including complete blood count will be conducted on Day 1 and Day 3. Data will be analyzed to determine whether CPLE leads to meaningful clinical improvements beyond standard care.
This study is expected to contribute important local data regarding the use of CPLE in pediatric dengue cases. If effective, this herbal adjunct could offer a low-cost, accessible therapeutic option. However, if no benefit is observed, the findings will help guide clinical practice away from potentially unnecessary interventions.
- Conditions
- Dengue Fever, Papaya Leaf Extract, Pediatric Patients
- Being tested
- Carica Papaya Leaf Extract Group, standard treatment
- Keywords
- effect of papaya leaf extract, dengue fever, platelet count
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carica Papaya Leaf Extract GroupDrug
Carica papaya leaf extract syrup will be administered orally at a dose of 10 mL three times daily (TID) for a total of 3 days. Each 10 mL dose contains 1000 mg of papaya leaf extract. This intervention will be given in addition to standard supportive therapy for dengue fever
standard treatmentOther
patients in this group will receive only the standard treatment for dengue fever
| Study group | Role | What they receive |
|---|---|---|
| Carica Papaya Leaf Extract Group | Experimental | 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. Receives: Drug: Carica Papaya Leaf Extract Group |
| Standard Therapy Group | Active comparator | 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. Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet Count from Day 1 to Day 3
To evaluate the effectiveness of Carica papaya leaf extract in increasing platelet count in pediatric patients with dengue-associated thrombocytopenia
Measured: Baseline (Day 1) and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guzel Maxood, Ziauddin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172100
- Sponsor's protocol ID
- 6600223GMPED
- Acronym
- papaya leaf
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Papaya Leaf Extract on Thrombocytopenia in Children With Dengue Fever at a Tertiary Care Center in Karachi
- ClinicalTrials.gov ID
- NCT07172100
- Acronym / sponsor ID
- papaya leaf / 6600223GMPED
- Conditions
- Dengue Fever, Papaya Leaf Extract, Pediatric Patients
- Keywords
- effect of papaya leaf extract, dengue fever, platelet count
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziauddin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Control group (n=52): Will receive standard supportive therapy alone.
The primary objective of the study is to assess whether CPLE significantly increases platelet counts from Day 1 to Day 3 compared to standard therapy alone. Secondary objectives include evaluating changes in hemoglobin levels, white blood cell (WBC) count, packed cell volume (PCV), need for platelet transfusion, and admissions to the Pediatric Intensive Care Unit (PICU).
Baseline demographics (age, gender, height, and weight) will be recorded. Laboratory tests including complete blood count will be conducted on Day 1 and Day 3. Data will be analyzed to determine whether CPLE leads to meaningful clinical improvements beyond standard care.
This study is expected to contribute important local data regarding the use of CPLE in pediatric dengue cases. If effective, this herbal adjunct could offer a low-cost, accessible therapeutic option. However, if no benefit is observed, the findings will help guide clinical practice away from potentially unnecessary interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carica Papaya Leaf Extract Group | Experimental | Drug: Carica Papaya Leaf Extract GroupParticipants 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. |
| Standard Therapy Group | Active comparator | Other: standard treatmentParticipants 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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with dengue fever
- Patients from age 2 till 2 years of age
Key exclusion criteria (2 listed)
- Patients hypersensitive to papaya leaf extract
- Patients with bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carica Papaya Leaf Extract GroupCarica papaya leaf extract syrup will be administered orally at a dose of 10 mL three times daily (TID) for a total of 3 days. Each 10 mL dose contains 1000 mg of papaya leaf extract. This intervention will be given in addition to standard supportive therapy for dengue fever | Drug | Carica Papaya Leaf Extract Group |
| standard treatmentpatients in this group will receive only the standard treatment for dengue fever | Other | Standard Therapy Group |
Primary outcome
Change in Platelet Count from Day 1 to Day 3
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carica Papaya Leaf Extract Group and standard treatment in people with Dengue Fever and Papaya Leaf Extract, run by Ziauddin Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Platelet Count from Day 1 to Day 3 (time frame: Baseline (Day 1) and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.