Clinical Research Registry

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INA-78S909M  Awal   The effects of a probiotic milk drink, Yakult®, containing Lactobacillus casei Shirota on the intestinal microbiota and intestinal environment in residents and staff at elderly houses in Indonesia 
Interventions: Intervention Group : Yakult®: Fermented milk drink containing over 6.5×109 CFUs of L. casei Shirota/65 ml, 1 bottle/day for 24 weeks (168 days). Placebo Group : Placebo: Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product. 1 bottle/day for 24 weeks (168 days). 
INA-XSPZF53  Awal   Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies 
Interventions: This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults. 
INA-TZ0XXFY  Awal   The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 
Interventions: This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and astaxanthin 6 mg tablet once daily (experimental group) 
INA-LYY8GNT  Awal   The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 
Interventions: This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin B combination (vitamin B1 100 mg, vitamin B6 200 mg, and vitamin B12 200 mcg) once daily (experimental group) 
INA-MEODDY6  Awal   The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 
Interventions: This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin D 5000 IU tablet once daily (experimental group) 
INA-PA2HB87  Awal   Effects of Dietary Intake and Supplementation of Indigenous Probiotic Lactobacillus plantarum Dad-13 on Body Mass Index, Faecal Short-Chain Fatty Acid, and Gut microbiota of Undernourished Children in East Lombok, Indonesia 
Interventions: Probiotic powder "ProbioGama" with probiotics Lactobacillus plantarum Dad-13 with viability 10^9 CFU/gram. 40 Subject divided into 2 groups : - Probiotic Group : Consume Probiotic Powder ProbioGama 1 sachet/ Day (1 sachet = 1 gram) - Plasebo group : consume skim milk powder 1 sachet (1 sachet = 1 gram) 
INA-2A8RG4R  Awal   PENGARUH KONSUMSI PROBIOTIK POWDER INDIGENOUS DALAM MENYEHATKAN SALURAN PENCERNAAN PADA PENDERITA OBESITAS 
Interventions: Intervensi Produk Probiotik Powder dengan viabilitas 10^9 CFU/Gram/Hari pada kelompok probiotik 
INA-N9A8PM2  Awal   Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) 
Interventions: • Drug: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) • Other: Placebo • Drug: Remdesivir 
INA-K2SGZ24  Awal   NA 
Interventions: 1. Sekitar 1 jam sebelum pemberian obat, subjek menjalani pemeriksaan fisik untuk data tanda vital awal (suhu tubuh, tekanan darah, denyut jantung / nadi, dan laju pernapasan). Subjek perempuan usia subur harus menjalani tes kehamilan urin. 2. Pada pukul 07:00 pagi, dosis oral tunggal 150 mg Pregabalin diberikan pada masing-masing subjek dengan 240 mL air dalam posisi duduk. 3. Subjek harus tetap dalam posisi duduk sampai periode 1 jam setelah pemberian obat. 4. Pemantauan tanda vital (body temperature, blood pressure, heart rate/pulse rate and, respiration rate): predose, 1, 2, 3, 4, 12, 24 dan 36 jam setelah pemberian obat. Subjek diinstruksikan untuk menginap satu malam sebelum dan selama periode pengambilan sampel setidaknya selama 24 jam setelah pemberian obat - Subjek diinstruksikan untuk berpuasa dari 8 jam sebelum sampai dengan 4 jam setelah obat administrasi - Menu yang disajikan dan makanan yang diambil oleh subjek distandarisasi dan dicatat - Air dapat dikonsumsi sesuai keinginan kecuali selama jangka waktu 1 jam sebelumnya sampai 2 jam setelah pemberian obat - Tanda-tanda vital (tekanan darah, nadi, laju respirasi dan suhu tubuh) adalah dipantau dan dicatat sebelum pemberian obat, dan selanjutnya pada 1, 2, 3, 4, 12, 24 dan 36 jam setelah pemberian obat. Keamanan subjek dipantau selama seluruh studi di bawah pengawasan langsung oleh Pelajari Dokter di lokasi penelitian. 
INA-1M7KY9N  Awal   Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference with Co-Administered EPI Vaccines (Phase III) 
Interventions: Investigational product: Rotavirus RV3 Vaccine (Bio Farma); Control product: Placebo 
INA-2GHFOKN  Awal   International SARS-CoV-2 Infection Observational Study (ICOS) 
Interventions: Tidak ada Intervensi 
INA-BB6K0Q7  Awal   Reducing the risk of Plasmodium vivax relapse after acute Plasmodium falciparum malaria in co-endemic areas - a randomized controlled trial (PRIMA STUDY) 
Interventions: Uji klinis terbuka, acak terkontrol dengan dua arm pada penderita P. falciparum, yaitu: i. Kelompok intervensi dengan pengobatan tambahan untuk P. vivax ii.Kelompok kontrol tanpa pengobatan tambahan untuk P. vivax 
INA-H9QLN22  Awal   Fase III, Acak-terbuka, Uji Klinik Efikasi dan Keamanan Favipiravir pada Pasien Covid-19 di Indonesia 
Interventions: Pemberian obat Uji dan Komparator Obat Uji Hari 1: Favipiravir 2 x 1600 mg (8 tablet), Hari 2 sampai hari ke 7 hingga maksimal 14 hari : Favipiravir 2 x 600 mg (3 tablet) sehari, + Azithromycin 1 x 500/hari selama 5 hari Komparator : + Azithromycin 1 x 500/hari selama 5 hari 
INA-HL5Q9B1  Awal   PlaSenTer 
Interventions: Plasma Convalescet @200mL, 2x pemberian dengan jangka waktu 3 hari 
INA-6E2YX0X  Awal   Solidarity Trial 
Interventions: Local standard of care alone, OR local standard of care plus one of • Remdesivir (daily infusion for 10 days) • Chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days) • Lopinavir with Ritonavir (orally twice daily for 14 days) • Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days). 
INA-TX6YYSS  Awal   Uji Klinis Fase III, Multisenter, Acak Terkontrol, Tersamar Ganda Membandingkan Efikasi Dan Keamanan Kombinasi Baru Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, Serta Hydroxychloroquine-Azithromycin Dengan Obat Standar Pada Pasien COVID-19 Yang Dirawat Di Rumah Sakit Dengan Derajat Ringan, Sedang, Dan Berat Yang Tidak Menggunakan Ventilator 
Interventions: Pasien positif COVID-19 yang dibuktikan dengan hasil PCR dan memenuhi kriteria inklusi serta eksklusi pada penelitian ini diberikan obat uji klinik selama 7-14 hari. Selama penelitian dilakukan evaluasi: 1. Evaluasi laboratorium (pemeriksaan darah lengkap, fungsi liver, fungsi ginjal, CRP, D-dimer, elektrolit) pada H-1 dan H-7. 2. Pemeriksaan EKG setiap hari 3. Pemeriksaan Rontgen Dada H-1, H-7, dan H-14, 4. Pemeriksaan PCR Kualitatif dan Kuantitatif (Jumlah Copy Virus) pada H-1, H-3, dan H-7. 5. Pemeriksaan Sitokin pada H-1 dan H-7. 
INA-QCA4OWA  Awal   Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled 
Interventions: Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 107cells of DW-MSC for the low-dose group or 1 x 108cells for the high-dose group after registration. 
INA-WXFM0YX  Awal   A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia 
Interventions: Investigational product: SARS-CoV-2 vaccine (inactivated) Control product: placebo 
INA-1LX0O6E  Awal   KAPSUL EKSTRAK ETANOL 70% TERFRAKSINASI DAUN J. gendarussa Burm. f SEBAGAI OBAT KB PRIA 
Interventions: Subyek akan diminta untuk minum dua kapsul ekstrak dengan dosis 450 mg ekstrak etanol 70% terfraksinasi daun J. gendarussa atau plasebo satu kali sehari, selama 12 bulan. Pada masa subur istri, pasangan diminta untuk melakukan hubungan seksual. Pasangan akan diamati selama 12 bulan masa masa minum obat, yang dilanjutkan dengan pengamatan reversibilitas 72 hari setelah putus obat, sesuai dengan lamanya proses spermatogenesis. 
INA-QXZNETK  Awal   Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV) 
Interventions: The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings. After obtaining fully informed consent, we will recruit healthcare workers, or other individuals at significant risk, who can be followed up reliably for up to 5 months. In Asia they will be randomised to receive either chloroquine or placebo (1:1 randomisation). In Europe they will be randomised to receive either hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10 mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months. Subsequent episodes of symptomatic respiratory illness, including symptomatic COVID-19, clinical outcomes, and asymptomatic infection with the virus causing COVID-19 will be recorded during the follow-up period. If they are diagnosed with COVID-19 during the period of prophylaxis, they will continue their prophylaxis unless advised to do so by their healthcare professional until they run out of their current supply of chloroquine/placebo at home. They will not collect more. They will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days). 
INA-EW74C1N  Awal   The Use of Biomaterials as Bone Substitute for Alveolar Cleft Patients 
Interventions: Intervention divided into 3 group; Group 1 : Alveolar cleft repair (gnatoplasty) with Poly-P as bone substitute, Group 2 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Poly-P as bone substitute, Group 3 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Microfragmented fat (MFAT) as bone substitute. 
INA-KGMRF0T  Awal   Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants 
Interventions: Investigational product: DTP-HB-Hib Vaccine (Bio Farma) using different source of Hepatitis B bulk and Recombinant Hepatitis B (Bio Farma) using different source bulk Control Product: Pentabio Vaccine® (Bio Farma) and Recombinant Hepatitis B® vaccine (Bio Farma) 
INA-HETTL12  Awal   D2EFT 
Interventions: Yes: Dolutegravir, Darunavir, Ritonavir 
INA-OL70Y5G  Awal   Integrasi Kesehatan Jiwa di Klinik HIV untuk Meningkatkan Keberhasilan Pengobatan Antiretroviral: Skrining Gangguan Depresi pada Orang Dengan HIV di Rumah Sakit 
Interventions: Tidak ada intervensi 
INA-WHMG3FX  Awal   The Benefit of Add on Vitamin D or Vitamin B combination or Either for Painful Diabetic Neuropathy 
Interventions: Add on vitamin D (400 IU) per day to standard treatment (pregabalin, gabapentin, or amitryptilin) 
INA-MZXONZG  Awal   Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to lot consistency, Non-inferiority to PQed TCV and Typhoid Vi Polysaccharide Vaccine 
Interventions: Vaksin Tifoid Konjugat (Vi-DT) 
INA-53EA9LH  Awal   The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study 
Interventions: This is a randomized controlled open label trial. There will be 2 groups in this study, group 1 consists of subjects treated with DLBS1033 + standard therapy of ischemic stroke, whereas group 2 consists of subjects treated with placebo of DLBS1033 + standard therapy of ischemic stroke. DLBS1033 and placebo of DLBS1033 will be given 2 tablets three times per day for 30 days. 
INA-F3KQ3DK  Awal   Comparison of Intravenous Ibuprofen and Ketorolac for Acute Musculoskeletal Pain from Various Etiologies 
Interventions: This is a quasi experimental, non randomized, non equivalent, active comparator, open label study. The intervention in this study is an intravenous 800 mg ibuprofen. The intravenous ibuprofen will be given every 12 hours. We will need 4 intravenous ibuprofen injection for every patient. There will be a total need of 120 IV ibuprofen injection for this study. The control in this study is an intravenous 30 mg ketorolac. The ketorolac injection will be given every 12 hours. 
INA-FBT1T7P  Awal   Evaluasi Ekonomi Intervensi Koroner Perkutan pada Pasien Angina Pektoris Stabil dan Sindrom Koroner Akut di Indonesia 
Interventions: Penelitian ini tidak melakukan intervensi kepada subjek. 
INA-DPS3T9B  Awal   Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children 
Interventions: Investigational Product Recombinant Hepatitis B (Bio Farma) Vaccine Form Liquid (in uniject) Dose 1 mL Route Intramuscular injection (deltoid) Batch Number 3660318UK Expiry Date September 2020 Active Comparator Recombinant Hepatitis B (Bio Farma) Vaccine® Form Liquid (in uniject) Dose 1 mL Route Intramuscular injection (deltoid) Batch Number 3660718 Expiry Date 31 August 2020