Quincy-sous-senart, France
The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers
Phase
N/ASpan
17 weeksSponsor
Indonesia UniversityJakarta
Recruiting
Healthy Volunteers
The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients
Subject allocation into groups will be made by third party to ensure masking/ blinding protocol. Data that will be taken from participants : - Private information - Medication history (for type 2 Diabetes Mellitus) - Food intake (calories, fats, carbohydrate, protein, and flavonoid intake) - Physical activity status
Phase
4Span
20 weeksSponsor
Indonesia UniversityJakarta
Recruiting
Effect GnRH Agonist Administration in Endometriosis Cyst Patients
There will be 2 groups of treatment; each group will consist of 16 subjects with study period for 18 weeks. Treatment I : twice before surgery (baseline and week-6) and once after surgery at week-12 Treatment II : once after surgery at week-12 The eligible subjects will be allocated to receive study medication (Treatment 1 or Treatment 2) in an open label study. They will be asked to come to the hospital every 6-week interval throughout the study period. Subjects will be evaluated based on the improvement in the degree of pain felt by the subjects using a visual analogue scale (VAS) on each visit throughout the study period (at baseline, week-6, week-12 prior to surgery and week-18), and Anti Mullerian Hormone (AMH) levels and estradiol levels at baseline and week-12 (prior to surgery). The condition of the uterus and cysts will also be evaluated at the time of surgery at week-12.
Phase
3Span
61 weeksSponsor
Rumah Sakit Pusat Angkatan Darat Gatot SoebrotoJakarta
Recruiting
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
Phase
N/ASpan
74 weeksSponsor
Dr Cipto Mangunkusumo General HospitalJakarta
Recruiting
Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia
The study will utilize qualitative and quantitative methods to: - Test different MMS delivery strategies (bottle count [90 vs. 180 tablets] and communication strategies [BCC vs. expanded BCC vs. MMS orientation only]) for enhancing supplementation consumption - measured as coverage and adherence. - Assess acceptability, feasibility, and fidelity of MMS program implementation within antenatal care services (ANC) More specifically, the investigators will implement and evaluate different MMS packaging (90 count bottle vs 180-count bottle) strategies and behavior change communication (BCC) strategies. The 3 BCC approaches are further described below. - BCC, BCC without Interpersonal Communication (IPC) strategy is a briefer more basic approach that hopes to improve health care providers knowledge about MMS and the providers ability to communicate with pregnant women. This approach will be rolled out by training one district-level facilitator in each district to become a trainer who will be responsible for training health providers in the corresponding study sub-districts. - Expanded BCC ('BCC with Interpersonal Communication [IPC]') needs more intensive training of master trainers to train health care providers and focuses more on the counselling skills portion. The BCC without IPC is more feasible to implement within the existing system, the investigators anticipate that the BCC with IPC achieve better behavior change results. - MMS Orientation: Women in the control group will receive the existing standard of counselling care. The providers will not be given any sort of training on counselling. Due to the fact that MMS is a new product that the providers will be providing pregnant women, all health care providers will receive a standard MMS orientation so providers are comfortable with the new supplement. The study will be conducted in 25 districts representing the western, central, and eastern regions of Indonesia, Indonesia's socio-cultural diversity, and varying capacity of ANC systems across districts. After selection, the 25 districts were divided to receive high-intensity (8 districts), moderate-intensity (5 districts), or low-intensity (12 districts) evaluation activities with those exposed to high-intensity evaluation efforts having comprehensive individual-level data collected by study employed data collectors while the low-and moderate-intensity district data collection efforts are being done within the context of the existing health system. 1. High intensity evaluation areas (8 districts) Evaluation of MMS acceptability, coverage, adherence, feasibility, and fidelity will include data collection from health professionals and pregnant women by study data collectors, and by ANC monitoring activities. 2. Moderate intensity evaluation areas (5 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, data collectors will collect MMS acceptability, feasibility, and fidelity data within 2 of those 5 districts. 3. Low intensity evaluation area (12 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, a household coverage survey will be administered in a subset of districts (n=6) post-intervention to examine MMS acceptability, adherence, coverage, and implementation feasibility and fidelity. The coverage survey will be designed after 6 months of implementation and will be submitted as a separate application to the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, and a separate entry into Clinicaltrials.gov. Within the 8 high-intensity districts and 5 moderate-intensity districts that are the subject of this Clinicaltrials.gov submission, the study will utilize a three-arm cluster randomized design (with sub-district health center as the unit of randomization).
Phase
N/ASpan
106 weeksSponsor
Johns Hopkins Bloomberg School of Public HealthJakarta
Recruiting
Healthy Volunteers
The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients
Subjects who meet the eligibility criteria will be classified into intervention and control groups based on their Qur'an listening routine. Those who listen to the Qur'an less than once a week will be included in the control group. On the other hand, those who listen to the Qur'an once or more a week will be included in the intervention group. Before the intervention, we will also evaluate the potential confounding factors in each respondent that could affect quality of life, such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety or depression, comorbidities, and economic status. Subjects in the intervention group will be asked to listen to the Al Qur'an recital (QS. Ar-Rahman) with a minimum duration of 15 minutes each, twice every day for 40 days, through an MP3 player using a headset or earphone. They will listen to the same Qur'an recital that is recited by Freed Ghalib. To ensure the respondents listen to the Qur'an recital Surah Ar-Rahman, the researcher will call and message via the Whats App application to research subjects every day for reminding. Respondents are also given a checklist card that will be filled out each time they are finished listening to the Qur'an recital. The control group will be asked not to change their habits of listening to or reading the Qur'an during this period. In addition, both the intervention and control groups will also be asked to inform the researchers if they read the Qur'an during the intervention or monitoring period.
Phase
N/ASpan
25 weeksSponsor
Indonesia UniversityJakarta
Recruiting
Healthy Volunteers
The Effect of Press Needle in the Combination of Ear and Body Acupuncture Points on Visual Analog Scale in Post-Operative Patients of Open Spine Surgery
Phase
N/ASpan
38 weeksSponsor
Indonesia UniversityJakarta
Recruiting
Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients
This study uses an open label randomized clinical trial (RCT) design, double arm which allows subjects and researchers to know the interventions received by subjects conducted on cancer patient subjects. The study aims to compare knowledge, attitudes, and actions related to nutrition consumption through questionnaires, nutritional status assessed from anthropometry (BW and BMI), nutrient intake, as well as laboratory results (Hb, serum albumin), and inflammatory markers (CRP, TNF-α, IL(interleukin)-1, IL-6) between the group of subjects who were given dietary counseling and ONS/oral nutrition supplement (intervention group) for 8 weeks compared to the group of subjects who only received dietary counseling and did not receive ONS (control group). Subjects who meet the inclusion criteria will be randomized into 2 groups using the stratified block randomization method stratified by age, and cancer type. Randomization will be carried out using a system in the application by stratifying the age of the subject based on the categorical age which has been categorized into 18-45 years and >45 years. For the type of cancer stratified into two, namely lung cancer and gynecology cancer according to the inclusion criteria. Both stratified will be randomized using excel application that will randomize 80 subjects at the beginning of the research study.
Phase
3Span
57 weeksSponsor
Kalbe International Pte. LtdJakarta
Recruiting
The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
A randomized control trial of two clusters : 1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients. Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level. In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations. Ultrasound examination was performed for both cluster since 1st until 3rd trimester.
Phase
N/ASpan
70 weeksSponsor
Dr Cipto Mangunkusumo General HospitalJakarta
Recruiting
Healthy Volunteers
The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post-ACS Patients
Design: This study is a single-blinded, randomized clinical trial conducted in the National Cardiovascular Center Harapan Kita, and aims to investigate the effect of the mobile application "HARKIT I-Care" on the morbidity and mortality of post-acute coronary syndrome patients. Subjects: Post-ACS patients hospitalized at the National Cardiovascular Center who are willing to be a subject in this research and have signed the informed consent form. Eligible subjects will be recruited and randomized to two groups: I-Care and control. Subjects in the I-Care group will be instructed to download 'HARKIT I-Care' application on their smartphone. Subjects will then be taught how to use the application, including logging blood pressure, blood sugar, and cholesterol levels, making use of exercise and medication reminders, and where to access health information and teleconsultation. Subjects are instructed to log their health parameters regularly according to the guidebook that has been prepared beforehand. Subjects in the control group will receive education on medication compliance and health information at the beginning of the enrolment. Education was conducted by another research team not involved in assessing outcomes. Randomization: We conducted stratified permutated block random sampling using a computer application. Stratification used were: (1) Gender: male and female, (2) Age: <65 and ≥65, and (3) Diagnosis: STEMI (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-segment Elevation Myocardial Infarction), and UAP (Unstable Angina Pectoris). Randomization was conducted using a computer app, and patient assignments were done using a sealed opaque envelope containing the assignment group. Randomization was conducted by a study statistician not involved in data collection. Outcome assessors were blinded to the treatment. Statistical Analysis plan: We planned on conducting a survival analysis for MACE (major adverse cardiovascular events), cardiovascular mortality, all-cause mortality, and rehospitalization rate. We also intended to analyze the effect of HARKIT I-Care on medication compliance, laboratory parameters, smoking cessation and relapse, sodium consumption, and physical activity.
Phase
N/ASpan
57 weeksSponsor
National Cardiovascular Center Harapan Kita Hospital IndonesiaJakarta
Recruiting