Investigating the Benefits of Kur-co Smart (Turmeric and Coconut Oil) for Faster Recovery in Dengue Fever Patients

1. Background
Registration Number	INA-T252KER
Date of registry approval	18-11-2024
Registration Date	11-11-2024
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	The Effect of Kur-co Smart (Curcumin and Virgin Coconut Oil Combination) on Platelet Count and Disease Severity in Patients with Dengue Fever: A Phase 2 Randomized Controlled Open Trial
Public (popular study title)	Investigating the Benefits of Kur-co Smart (Turmeric and Coconut Oil) for Faster Recovery in Dengue Fever Patients

2. Sponsor and Funding
Primary Sponsor	Universitas Sebelas Maret
Source(s) of monetary or material support	Universitas Sebelas Maret
Other partners	not specified

3. Contact details
Principal Investigator
Principal investigator	Hartono
City	Sukoharjo
Country	Indonesia
Principal investigator's affiliation	Universitas Sebelas Maret
Principal Investigator's email address	hartono65@staff.uns.ac.id
Public Queries
Contact person name for public queries	Nurhasan Agung Prabowo
Address for public queries	Ahmad Yani street no 200 Makam Haji Kartasura
City	Sukoharjo
Country	Indonesia
ZIP	57161
Affiliation for public queries	Universitas Sebelas Maret
Email address for public queries	dr.Nurhasan@gmail.com
Phone number for public queries	085875703415
Scientific Queries
Name of Contact for scientific queries	Nurhasan Agung Prabowo
Address for scientific queries	Ahmad Yani street no 200 Makam Haji Kartasura
City	Sukoharjo
Country	Indonesia
ZIP	56161
Affiliation of scientific queries contact	Universitas Sebelas Maret
Email address for scientific queries	dr.Nurhasan@gmail.com

4. IRB & Regulatory
Ethical Approval number	001/UN27.4.6/TA.04.19/EC/2024
Name of Ethics committee	The Health Research Ethics Committee of Universitas Sebelas Maret Hospital
Date of Ethic approval	09-09-2024
Contact details of Ethic Committee (phone, email, and office)	Office Address: Rumah Sakit Universitas Sebelas Maret (RS UNS), Jalan Ahmad Yani Nomor 200 Makamhaji, Kartasura, Sukoharjo 57161, Indonesia. Phone: (0271) 7461665, 6775000 Email: rsuns@mail.uns.ac.id
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	Rumah Sakit Universitas Sebelas Maret (RS UNS), Sukoharjo, Jawa Tengah
Recruitment status	Recruit
Date of first enrollment	01-10-2024
Targeted Sample size	00040 -
Number of enrolled participants	40
Date of study completion (last participant, last visit)

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Dengue Fever (Demam Berdarah Dengue - DBD).
Purpose of the study	Treatment
Study type	Interventional
Interventional Study category	Clinical trial
Study phase	Phase 2
Method of allocation	Randomized allocation
Description of the allocation concealment mechanism and sequence generation	The allocation concealment mechanism in this study involved randomized allocation through a controlled process to ensure unbiased assignment. The sequence generation was conducted using randomization techniques, where participants were assigned to either the control group or the intervention group (receiving Kur-co Smart) using an independent random sequence generator. Concealment was maintained by using numbered, sealed, and opaque envelopes to prevent knowledge of group assignment until the point of allocation. This ensured that both participants and investigators remained blinded to the allocation sequence until the intervention was assigned.
Masking	Participant, Care provider, Investigator, Outcome assessor
Study intervention (study arm)	Kur-co Smart (combination of curcumin 500 mg and virgin coconut oil 500 mg). This intervention is administered alongside standard care for patients.
Control intervention (control arm)	Placebo
Intervention assignment	Parallel

7. Eligibility Criteria
Gender inclusion criteria	Not specified
Minimum age	18
Maximum age	65
Inclusion criteria	Adults aged 18-65 years, confirmed Dengue Fever (DHF) grades I-III, laboratory platelet count
Exclusion criteria	Pregnant or breastfeeding women, patients with a diagnosis of cancer, chronic kidney failure, chronic liver disease, acute heart failure, or blood disorders, patients currently participating in other clinical trials, history of allergy to the investigational product, patients with organ failure complications.

8. Study Outcome
Primary Outcome
Name of primary outcome	The primary outcome is change in platelet count in patients with Dengue Fever.
Metric/method of measurement	The metric/method of measurement for the primary outcome is platelet count, measured using standard hematological laboratory tests before and after the 3-day intervention period.
Timepoint(s) of measurement	The timepoints of measurement are Day 0 (baseline) before the intervention and Day 3 after the completion of the 3-day intervention period.
Secondary outcome 1
Name of secondary outcome 1 (SO1)	change in hematocrit levels.
Metric/method of measurement (SO1)	The metric/method of measurement for secondary outcome 1 (SO1) is hematocrit levels, measured using standard hematological laboratory tests at specified timepoints.
Timepoint(s) of measurement (SO1)	The timepoints of measurement for secondary outcome 1 (SO1) are Day 0 (baseline) before the intervention and Day 3 after the 3-day intervention period.

9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic	Age, gender, initial platelet count, initial hematocrit level, and Dengue Fever severity grade (I-III).
Adverse events
Outcome measures

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	Undecided
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	not specified