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NCT ID: NCT04613271 Completed - Covid19 Clinical Trials

Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

FVR
Start date: October 15, 2020
Phase: Phase 3
Study type: Interventional

The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.

NCT ID: NCT04613258 Completed - Tuberculosis Clinical Trials

Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications

Start date: May 11, 2019
Phase: N/A
Study type: Interventional

Tuberculosis patients that have complications (e.g., diabetes mellitus and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)) who live in tropical regions experience vitamin D deficiency, especially in North Sumatra, Indonesia. The presence of vitamin D receptor (VDR) polymorphism genes, TaqI and FokI, is one of the predisposing factors, as is high levels of inflammatory markers, also indicating disease progression and malnutrition. This study aims to assess the effect of 50 g of soy-catfish-anchovy-rice (SCAR) porridge per day for 14 days on 25(OH)D, calcium, and biomolecular serum levels in patients with VDR gene polymorphisms (TaqI or FokI). The study was a parallel, open, clinical trial. A total of 43 subjects with the VDR gene polymorphisms were selected. The subjects were divided into two groups using block randomization. There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling, and 21 subjects in the control group (C) who only received dietary counseling.

NCT ID: NCT04599127 Completed - Clinical trials for Shoulder Impingement Syndrome

The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome

SIS
Start date: August 12, 2019
Phase: N/A
Study type: Interventional

This study conducted to see the effect of adding mobilization with movement to conventional physical therapy to the subject with shoulder impingement syndrome. The shoulder impingement syndrome is often described as anterior lateral shoulder pain that provoked during shoulder elevation. The pain occurs during shoulder elevation and causes limited range of motion. Moreover, the patients with shoulder impingement syndrome commonly had a forward head posture and slouching shoulder. There is a theory that illustrates the mechanical factors lead to the injury of the bursa or rotator cuff tendons below the subacromial space which is highly related to the posture and scapular movement. Various treatments for shoulder impingement syndrome including medical treatments such as anti-inflammatory drugs, subacromial decompression, and acromion resection surgery. Conventional physical therapy treatments for shoulder impingement syndrome included modalities, exercises and manual therapy. Exercise has been showed to give a significant effect to decrease the pain intensity, increasing the range of motion and shoulder function. There is evidence that supports the use of manual therapy on shoulder impingement, the recent technique introduced by Brian Mulligan is mobilization with movement. Mobilization with movement is a manual therapy technique that uses the active movement while the physical therapist applies an accessory force to align the positional fault of the joint. A previous study investigated the effect of mobilization with movement that uses the mobilization with movement in shoulder impingement syndrome showed different outcomes in the measurement of pain intensity and shoulder range of motion. As the posture may be related to shoulder impingement syndrome, this research will measure the cervical posture, shoulder posture, and muscle strength. Therefore, the purposes of this study will be to compare the effects of conventional physical therapy treatments and the conventional therapy treatments plus the mobilization with movement on pain intensity, shoulder range of motion, cervical and shoulder posture, shoulder muscle strength and shoulder function. The study hypothesis was that mobilization with movement is more effective in improving the investigated outcomes in individuals with shoulder impingement syndrome than the conventional physical therapy.

NCT ID: NCT04594330 Recruiting - Clinical trials for Coronavirus Infections

Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.

NCT ID: NCT04593524 Completed - Tuberculosis Clinical Trials

The Role of Vitamin D, A, and Beta Carotene in Tuberculosis Patients With Vitamin D Receptor Gene Polymorphism

Start date: May 14, 2019
Phase: N/A
Study type: Interventional

Recent studies showed that vitamin D and A has an effect in improving sputum conversion in tuberculosis. This study aims to find out the effect of vitamin D 1000 IU and A 6000 IU supplementation on Tuberculosis patients with vitamin D receptor gene polymorphism, who live in North Sumatera, Indonesia. This study is a randomized control clinical trial, with 48 tuberculosis patients with vitamin D receptor gene polymorphism which are TaqI and FokI participating, divided into two groups, each with 24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU, and control group (C) which only receives nutritional counseling for 28 days. Patients who participated was found to be heterozygous with TaqI (T>C) or FokI (C>T) genotype variants.

NCT ID: NCT04591457 Not yet recruiting - Diabetes Mellitus Clinical Trials

The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus

Start date: October 2020
Phase: Phase 2
Study type: Interventional

This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients

NCT ID: NCT04587544 Completed - Gout Arthritis Clinical Trials

The Relationship Between Cold Water Immersion and the Progression in Gout Arthritis

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Gouty arthritis is a type of autoinflammatory arthritis that generates higher levels of pain with only minimum movement in the joint. The pain is shown to have a negative correlation with the physical function, reduced peak ankle joint angular, mobility velocity , and physical function. As such, the investigator can conclude that gout arthritis led to raises intolerance foot pain, physical inactivity, and joint mobility reduction. Currently, intermittent drugs use for pain relief is suggested to contribute to the renal impairment side effect. However, the investigator found that there is a limited study that investigated non-pharmacological intervention among people with gouty arthritis. The pain among people with gouty arthritis has also been shown to increase the degree of depression, anxiety, and depression. Also, the high levels of pain, psychological distress, anxiety, and depression were found as the risk factor of poor Quality of Life (QOL). Cold therapy (cryotherapy) application has been proven as useful adjuvant therapy on pain among people with gouty arthritis. CWI therapy has twofold reduced the inflammation. Firstly, it attenuates metabolic processes in stressed tissues and slowing cytokine and myokine up-regulation that mediates inflammation. Second, CWI induces microvasculature vasoconstriction by perfusing stressed tissue and reducing the circulatory of tissue access to inflammatory cells. Meanwhile, the high prevalence of gouty arthritis has been presented in North Celebes, Indonesia. Moreover, more than 50% of patients are too late for effective therapy and they had observed tophi for 7 to 9 years before presenting for treatment. These empirical issues indicate that it is vital to investigate gouty arthritis-related risk factors to protect Indonesians from this disease. The investigator aims to investigate a unique analysis of the CWI (20-30C) therapy effect on pain, joint mobility, stress, anxiety, depression, QOL (encompasses PCS and MCS), physical activity (MET-h/week) in the multicenter-community setting with a longitudinal study design.

NCT ID: NCT04578145 Recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Community Based Screening for HIV Self Testing in FSW in 23 Priority Districts in Indonesia

CBS-FSW
Start date: April 17, 2020
Phase: N/A
Study type: Interventional

Indonesia is not yet on course to end HIV and AIDS by 2030. Epidemic transmission of HIV infection among key affected populations (KAPs), specifically FSWs, crucially has contributed to not achieving the target. Although the number of HIV tests performed annually has grown steadily in recent years, reaching 3,077,653 in calendar year 2018, pregnant women is accounted for a fairly large proportion of an increased number of persons being tested (MoH, 2018). Regarding the FSWs, it has been a significant challenge to increase HIV testing uptake among this population. The challenge has been affected by Indonesia's national policy to close brothels. As consequence, many FSWs have become hidden and hard to reach. The implementation national policy also impacts on the way of commercial sex transactions in which it becomes underground, especially many FSWs utilize the new popularity of digital platforms to sell sexual services. It needs more effective case finding strategies to be implemented to reach them accordingly. If it is considered from the FSWs side, there are some barriers to access HIV test services according to several reports. They consist of lack of money, time, stigma, discrimination, low-risk perception, fear, lack of accessibility, reluctance of health service providers to offer HIV testing and limited human resources. Oral fluid HIVST using is an alternative to traditional HIV testing services in the facility or other healthcare provider testing (UNAIDS, 2016). For this study, OraQuick is used as an alternative strategy for HIV testing among FSWs. The primary objectives of this study are to assess whether proportion of FSW, who know their HIV status, increases or not; whether introduction of Oral fluid test increases the number of HIV testing at health facilities or not; and whether "assisted" or "unassisted" community HIV screening have a result to an increasing proportion of HIV testing at health facilities or not. Furthermore, CBS study aims to assess whether "assisted" and "unassisted" community HIV screening results to an increasing number of HIV positive case finding or not; and whether community HIV screening increases proportion of initiation of antiretroviral therapy (ART) or not. The secondary objectives of this study, meanwhile, are to measure acceptability of community-based self-screening in participation and to measure satisfaction of FSWs, who has participated, towards the delivery of community-based self-screening. Regarding the inclusion criteria of this study, participant must be women 18 years old or older at enrollment; has a transactional sex (vaginal, oral and/or anal) at least once in the past month; does not uptake HIV test in the last 6 months; and acknowledges her HIV status 'negative' or 'unknown'. There are several exclusion criteria, which are FSW does not able to fulfill one of inclusion criteria that has been explained above; FSW does not has desire to participate due to several reasons; and she is currently participating in another HIV prevention study. Outcome variables of this study are to compare the characteristic FSWs who receive self-testing and blood testing; who receive assisted and unassisted self-testing. Moreover, it compares the proportion of taking confirmatory test out of those who receive the test in the assisted and unassisted self-testing; proportion of FSWs who receive HIV test out of those who got offered for the test (including self-testing) in the intervention group with proportion of FSWs who receive HIV test in the control group; the proportion of FSWs taking confirmatory test (including self-testing) out of those receive the test in intervention groups and control group. It compares, furthermore, the proportion of HIV positive in the assisted, unassisted (intervention) and HIV positive in the control group. This study also compares ART initiation in the assisted, unassisted (intervention) and the control group. Additionally, it compares stigma scores and FSWs who went to a health facility for HIV testing between assisted, unassisted group and compares the HIV and STI risk behaviors between assisted and unassisted group. It calculates, lastly, the cascade of HIV testing and treatment.

NCT ID: NCT04574622 Completed - Cerebral Palsy Clinical Trials

Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy

Start date: January 17, 2020
Phase: N/A
Study type: Interventional

Spasticity, defined as a velocity dependent increase in tonic stretch reflexes, is one of the most prominent motor problems that occur in patients with cerebral palsy (CP). This causes difficulty in achieving balance, mobility, and an upright stance. CP is a group of permanent disorders that affect the development of movement and posture caused by a non-progressive damage to the brain. Because CP occurs in 2-3 of 1000 individuals, it is one of the most common causes of severe physical disability in children. Mismanagement of spasticity can lead to contracture which is extremely difficult to treat and may result in severe functional disabilities. The current management of spasticity in CP includes physical therapy (i.e. passive stretching), oral medication, botulinum toxin injection, and surgery. Botulinum toxin injection has been proven to effectively reduce spasticity yet many patients are unable to get access to this treatment due to its high cost. Moreover, Botulinum toxin injection is currently not covered by the public health insurance of Indonesia. Therefore, other modalities which are more affordable and are non-invasive therapies should be considered as a treatment option for spasticity. Radial Extracorporeal Shockwave Therapy (rESWT) has been utilized in the medical practice for the treatment of several musculoskeletal disorders such as chronic tendinopathies and spasticity. It is hypothesized that ESWT has two main effects which include a direct effect from mechanical forces at the treatment point and an indirect effect from cavitation. Even though rESWT has less penetration capacity over the focused Extracorporeal Shockwave Therapy (fESWT), rESWT is still believed to be more superior to fESWT because it requires less precise focusing, is less painful, and costs less. These also make rESWT the more appropriate choice for children with CP. Many studies have proven the efficacy of ESWT in reducing spasticity in spastic CP patients with significantly long lasting effects. Despite promising results, there still has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One of the critical parameters needed to be determined is the frequency of treatment. Therefore, the objective of this study is to understand whether the reduction in gastrocnemius stiffness in children with spastic CP is influenced by the frequency of ESWT sessions.

NCT ID: NCT04567498 Recruiting - Tuberculosis Clinical Trials

eNose-TB: Electronic Nose for Tuberculosis Screening

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

An electronic-nose (e-nose) had been investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis.