Identifikasi Faktor Risiko dan Uji Efektivitas Antioksidan Imunomodulator Madu Temulawak-jinten hitam Terhadap Anak Stunting di Kabupaten Cirebon
| 1. Background | |
|---|---|
| Registration Number | INA-Y6CT9L0 |
| Date of registry approval | 27-11-2023 |
| Registration Date | 25-11-2023 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Uji efektivitas madu temulawak-jinten hitam |
| Public (popular study title) | Identifikasi Faktor Risiko dan Uji Efektivitas Antioksidan Imunomodulator Madu Temulawak-jinten hitam Terhadap Anak Stunting di Kabupaten Cirebon |
| 2. Sponsor and Funding | |
| Primary Sponsor | Yayasan Pendidikan Imam Bonjol |
| Source(s) of monetary or material support | Universitas YPIB Majalengka |
| Other partners | |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Siti Pandanwangi TW |
| City | Majalengka |
| Country | Indonesia |
| Principal investigator's affiliation | Fakultas Farmasi, Universitas YPIB Majalengka |
| Principal Investigator's email address | sitipandanwangi@gmail.com |
| Public Queries | |
| Contact person name for public queries | Siti Pandanwangi |
| Address for public queries | Jl. Gerakan Koperasi No.003, Majalengka Wetan, Kec. Majalengka, Kabupaten Majalengka, Jawa Barat 45411 |
| City | Majalengka |
| Country | Indonesia |
| ZIP | 45411 |
| Affiliation for public queries | Fakultas Farmasi, Universitas YPIB Majalengka |
| Email address for public queries | sitipandanwangi@gmail.com |
| Phone number for public queries | 089661002386 |
| Scientific Queries | |
| Name of Contact for scientific queries | Siti Pandanwangi |
| Address for scientific queries | Jl. Gerakan Koperasi No.003, Majalengka Wetan, Kec. Majalengka, Kabupaten Majalengka, Jawa Barat 45411 |
| City | Majalengka |
| Country | Indonesia |
| ZIP | |
| Affiliation of scientific queries contact | Fakultas Farmasi, Universitas YPIB Majalengka |
| Email address for scientific queries | sitipandanwangi@gmail.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | 003/KEPK/EC/III/2023 |
| Name of Ethics committee | Universitas YPIB |
| Date of Ethic approval | 11-02-2023 |
| Contact details of Ethic Committee (phone, email, and office) | (0233) 284098 |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | Not applicable |
| 5. Status | |
| Countries of recruitment | Cirebon |
| Study sites in Indonesia | Cirebon |
| Recruitment status | Complete |
| Date of first enrollment | 19-05-2023 |
| Targeted Sample size | 00050 - |
| Number of enrolled participants | 50 |
| Date of study completion (last participant, last visit) | 02-08-2023 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | medication error |
| Purpose of the study | Prevention |
| Study type | Interventional |
| Interventional Study category | Interventional, other than clinical trial |
| Method of allocation | Non-randomized allocation |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | No (open) |
| Study intervention (study arm) | Intervensi adalah pemberian madu temulawakjinten hitam pada balita stunting dengan dosis sehari 1 sendok teh selama 4 bulan. Pengambilan darah pertama sebanyak 3 cc sebelum perlakuan, dan pengambilan darah kedua setelah 4 bulan pemberian madu. Parameter yang diukur adalah kadar Hb, Leukosit, trombosit, Superoxide dismutase, Catalase, Glutation peroksidase, CD4, IgM, interleukin-1, Insulin like Growth Factor dan parameter fisik BB, TB, LL, dan LK |
| Control intervention (control arm) | - |
| Intervention assignment | Single arm |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | 0 |
| Maximum age | 5 |
| Inclusion criteria | Balita yang mengalami stunting, tidak sedang sakit, tidak cacat mental |
| Exclusion criteria | orang tua tidak mengisi inform concent, orang tua pindah domisili diluar jangakauan peneliti |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Diketahuinya Faktor risiko dari yang besar pengaruhnya sampe yang terkecil sebagai pencetus terjadinya stunting. Untuk uji efektivitas antioksidan dengan parameter SOD, MDA, NO,GPx, Cat. Parameter imun IL-1, Leukosit, Hb. Parameter fisik IGF-1, TB, BB, LK, LL |
| Metric/method of measurement | Analisa darah dilakukan di 2 tempat, di RS Muhammadiyah dan di Laboratorium Fisiologi Fakultas Kedokteran Universitas Brawijaya |
| Timepoint(s) of measurement | Antisipasi Studi Dimulai Tanggal dimulai 19 Januari dan perlakuan terakhir 19 Mei 2023 |
| 9. Study Results | |
| Brief summary of study results | Ditemukannya hasil untuk uji efektivitas antioksidan dengan parameter SOD, MDA, NO,GPx, Cat. Parameter imun IL-1, Leukosit, Hb. Parameter fisik IGF-1, TB, BB, LK, LL |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | |
| 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)) | |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | |