No Registry |
Status |
Registry |
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. |
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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) |
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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) |
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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 |
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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. |
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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 |
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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 |
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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. |
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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 |
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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) |
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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) |
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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. |
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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 |
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