There are about 1183 clinical studies being (or have been) conducted in Indonesia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.
Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. The provision of probiotic Lactobacillus plantarum IS-10506, an Indonesian original probiotic strain, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.
This is a 2-arm, prospective, double-blind, randomized and placebo-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), for a 4-week course of therapy, for the treatment of patients with functional dyspepsia (FD), and an additional 8 weeks after end of therapy (Week 12) for follow-up visit. The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. The mechanism altogether demonstrated DLBS2411's protective capacity to the gastric and colon mucosa by promoting mucous synthesis and stimulating mucosal blood flow. Having such mechanisms of action, DLBS2411 is hypothesized to benefit subjects with gastric acid disorders such as in functional dyspepsia, gastro-intestinal reflux disease (GERD), peptic-ulcer, and irritable bowel syndrome (IBS).
This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks. The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.
This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.
In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine storm syndrome. SARS-CoV-2 works like a hijacker (hackers), sabotaging communication between cells so that the immune system, like T-cells, kills not only infected cells but also healthy cells. This dysregulation results in hyper-inflammation which cause damage to organs, not just the lungs. This is the cause of the high mortality rate in COVID-19 patients. Exosomes are vesicles with a size of 30-100 nanometers originating from within cells that function to communicate with other cells. Exosomes are transport containers that contain bioactive cargo: such as proteins, genetic material, and various other molecules. These containers move from cells of origin, flowing through blood vessels or other body fluids to target cells. Exosomes penetrate the cell membrane and act on various organelles within the target cell. All cell types can produce exosomes. What differentiates them is the cargo they contain. The exosome produced by mesenchymal stem cells (MSCs) contains bioactive cargo derived from mesenchymal stem cells, such as anti-inflammatory cytokines, growth factors, messengerRNA (mRNA) and microRNA (miRNA). The target cells are immune system cells, infected cells and progenitor cells from infected organs. On target immune cells, the anti-inflammatory cytokines work as immunomodulators to relieve hyper-inflammation. In infected cells, the miRNAs work to prevent viral replication by inhibiting the expression of SARS-CoV-2 virus RNA (viral mRNA silencing and degrading). In lung progenitor cells and other infected organs, the growth factors work to stimulate protein synthesis processes that function for organ regeneration. This study is a multi-center, double-blind, randomized controlled trial (RCT) clinical trial with two arms: one intervention arm, and one control arm. The EXOSOME-MSC will be tested as adjuvant, on top of standard COVID-19 drugs. It will be injected to participants via intravenous route twice, in day-1 and day-7 of 14 days of study participation.
The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp
The clinical study will compare the efficacy and safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate cream post fractional CO2 laser. Combination of Spent Grain Wax, Argan Oil, and Shea Butter was formulated to reduce skin irritation and allergy symptoms such as dryness, itch and rash. The combination cream applied on one side of the face while placebo will be applied on the other side of the face in 18-60 years old female post fractional CO2 laser.
Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there was no change in the way of titration, start low go slow, which resulted in difficulties in reaching optimal doses for some patients.
The 2019 Coronavirus disease outbreak (COVID-19) was first reported at the end of 2019 in Wuhan China as a severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. In less than a year, SARS-CoV-2 infection has become a pandemic and spread to almost all countries in the world, including Indonesia. World Health Organization data states that there are 4,240,479 confirmed cases of SARS-CoV-2 in Indonesia until 25 October 2021 with a death rate of 143,235 (WHO, 2021a). The Indonesian National Agency of Drug and Food Control (NA-DFC) has issued an Emergency Use Authorization for several SARS-COV-2 Vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (BPOM, 2021). Clinical data that the actual immune responses decrease after several months are continuously being reported (Marmot et al., 2021), and the decrease of vaccine efficacy due to the appearance of variants is also known (Abu-Raddad et al., 2021; Lopez Bernal et al., 2021). These potential risks suggest the need for a booster dose or periodic booster doses of the SARS-COV-2 Vaccine. In fact, there is a study result given several months after vaccination, which leads to the generation of a higher immune responses (Pan H et al., 2021). Booster dose of SARS-COV-2 Vaccine will either induce a high level of antibody responses against original strain, or enhance the broadly formed T cell immunity regardless of mutant strain to improve individual protection.