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| Name | Class |
|---|---|
| Indonesian Directorate General of Higher Education | OTHER_GOV |
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Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment. This study aimed to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight and physical function changes among active pulmonary tuberculosis patients with standard therapy.
This study was carried out at the outpatient department building, lung hospital Surabaya, Indonesia. As a national health referral system in TB program, the hospital was related to four local sub district health centers that were involved in the recruitment of participants in the study.
Patients with newly diagnosed pulmonary tuberculosis were randomly assigned into two groups, namely intervention group, which consisted of 65 participants and control group which had 64 participants. Randomization was carried out using sealed, unmarked opaque envelopes that are allocated to participants in this study. A minimum sample size of per group (n=64) was determined by Windows version G*Power 3.1.5 software to identify a mean difference in body weight change of ≥1.1 kg between intervention and control groups.
The intervention group obtained the standard therapy of TB and an additional 166.5 grams of boiled tempeh daily for two months. The control group obtained only standard TB therapy. Patients in the intervention group were instructed to divide one cake tempeh into three pieces and eat them three times in a day. Consumption frequencies of supplements were recorded in a logbook by an enumerator during random visits once a week. One of the patient family members was asked to help to supervise compliance.
The participants were assessed before and after the intervention period for both groups. Body weight of the participants was evaluated by measuring the change in body weight. The change of physical function was assessed by handgrip strength using a digital dynamometer and 6-minute walk test (6MWT). Protein and caloric intakes were estimated twice, measured during the first and second months using 24-hour dietary recall method during the intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets and 166.5 grams cooked fermented soybean (tempeh) daily for two months |
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| Control | Active Comparator | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months | Change of body weight of the participants over the two months intervention period as measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. A higher value score in change means a better outcome on nutritional status for the patients after the study. | Baseline, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months | The change of hand-grip strength of the participants over the two months intervention period was measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. The higher scores reflected the better physical function outcomes of the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | The average calorie intake (in kcal/day) was assessed by the 24-hour dietary recall questionnaire and calculated by NutriSurvey software version 2005, with the country-specific food database for Indonesia. | In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Krawinkel, Prof. Dr. | University of Giessen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15277171 | Background | Paton NI, Chua YK, Earnest A, Chee CB. Randomized controlled trial of nutritional supplementation in patients with newly diagnosed tuberculosis and wasting. Am J Clin Nutr. 2004 Aug;80(2):460-5. doi: 10.1093/ajcn/80.2.460. | |
| 19858174 | Background | Martins N, Morris P, Kelly PM. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. BMJ. 2009 Oct 26;339:b4248. doi: 10.1136/bmj.b4248. |
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After the enrollment of the study, several participants withdrew their assignment due to several reasons such as underlying disease, heavy smoker, they did not stay in the city, plan to move to other city, and dislike the food.
Between November 2013 and February 2015, patients who attended the lung clinics in Surabaya for newly diagnosed pulmonary TB were screened for study enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets and 166.5 grams cooked fermented soybean (tempeh) daily for two months Rifampicin Isoniazid Pyrazinamide Ethambutol Fermented soybean |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Isoniazid |
| Drug |
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| Pyrazinamide | Drug |
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| Ethambutol | Drug |
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| Fermented soybean | Dietary Supplement |
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| Baseline, 2 months |
| Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months | The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes. | Baseline, 2 months |
| Change in Body Mass Index (BMI) From Baseline at 2 Months | The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients. | Baseline, 2 months |
| Protein Intake on 24-hour Dietary Recall Method. | The average protein intake (in Gram/day) was assessed by the 24-hour dietary recall questionnaire and calculated using NutriSurvey software version 2005, with the country specific food database for Indonesia. | In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week. |
| 21221502 | Background | Jahnavi G, Sudha CH. Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting. Singapore Med J. 2010 Dec;51(12):957-62. |
| 21729372 | Background | PrayGod G, Range N, Faurholt-Jepsen D, Jeremiah K, Faurholt-Jepsen M, Aabye MG, Jensen L, Jensen AV, Grewal HM, Magnussen P, Changalucha J, Andersen AB, Friis H. The effect of energy-protein supplementation on weight, body composition and handgrip strength among pulmonary tuberculosis HIV-co-infected patients: randomised controlled trial in Mwanza, Tanzania. Br J Nutr. 2012 Jan;107(2):263-71. doi: 10.1017/S0007114511002832. Epub 2011 Jul 6. |
| FG001 | Control | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets Rifampicin Isoniazid Pyrazinamide Ethambutol |
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| NOT COMPLETED |
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The Baseline Analysis Population of the participants was assessed by age, gender, education, income, occupation, ethnicity, sputum smear examination result, and Body Mass Index.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets and 166.5 grams cooked fermented soybean (tempeh) daily for two months Rifampicin Isoniazid Pyrazinamide Ethambutol Fermented soybean |
| BG001 | Control | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets Rifampicin Isoniazid Pyrazinamide Ethambutol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants were newly diagnosed adult male and female pulmonary TB active patients aged between 18 and 55 years. | The number of Baseline Participants was assigned to the arm groups based on the inclusion and exclusion criteria. Some of them have rejected and withdrawn for some reasons such as objection and underlying diseases. | Count of Participants | Participants | No |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | Kg/m² |
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| Education | Count of Participants | Participants |
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| Income (million rupiahs) | Count of Participants | Participants |
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| Occupation | Count of Participants | Participants |
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| Sputum Smear | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months | Change of body weight of the participants over the two months intervention period as measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. A higher value score in change means a better outcome on nutritional status for the patients after the study. | All participants were assessed their body weight (kg) using an electronic weight scale before and after the study to determine its change. | Posted | Mean | Standard Deviation | Kilogram | Baseline, 2 months |
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| Secondary | Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months | The change of hand-grip strength of the participants over the two months intervention period was measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. The higher scores reflected the better physical function outcomes of the patients. | All participants were measured from two-times points, before and after the study in order to analyze their change after 2 months of intervention. Higher values reflected better physical function results. | Posted | Mean | Standard Deviation | Kilogram | Baseline, 2 months |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months | The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes. | Not all participants were analyzed before and after the study to measure the change in the distance. Only 64 participants from the intervention group and 63 participants from the control group contributed to data collection. | Posted | Mean | Standard Deviation | Meter | Baseline, 2 months |
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| Secondary | Change in Body Mass Index (BMI) From Baseline at 2 Months | The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients. | All participants were assessed before and after the study using a standard formula to determine the change of the body mass index (BMI). | Posted | Mean | Standard Deviation | Kg/m² | Baseline, 2 months |
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| Other Pre-specified | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | The average calorie intake (in kcal/day) was assessed by the 24-hour dietary recall questionnaire and calculated by NutriSurvey software version 2005, with the country-specific food database for Indonesia. | Not all participants were assessed their calorie intake, only 61 participants in the control arm and all participants from intervention contributed to the data collection. | Posted | Mean | Standard Deviation | Kcal/day | In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week. |
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| Other Pre-specified | Protein Intake on 24-hour Dietary Recall Method. | The average protein intake (in Gram/day) was assessed by the 24-hour dietary recall questionnaire and calculated using NutriSurvey software version 2005, with the country specific food database for Indonesia. | Not all participants were assessed before and after the study, only 61 participants from the control group contributed to the data collection of the study. | Posted | Mean | Standard Deviation | Gram/day | In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week. |
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The intervention period was 2 months for each participant who is eligible for the study. All participants were assessed at month zero (baseline) and month two (end line). The recruitment method was not a one-time event but a referral from physicians. Since eligible participants were not always available every day at the clinics thus the adverse data collection period for all participants was 1 year and 3 months.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, are the same from the clinicaltrials.gov definitions. Observation for adverse event was done three times a week since the food should be delivered regularly and regular notes taken on a log book.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets and 166.5 grams cooked fermented soybean (tempeh) daily for two months Rifampicin Isoniazid Pyrazinamide Ethambutol Fermented soybean | 0 | 75 | 0 | 75 | 1 | 75 |
| EG001 | Control | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets Rifampicin Isoniazid Pyrazinamide Ethambutol | 0 | 72 | 0 | 72 | 0 | 72 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Vomiting | Non-systematic Assessment |
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It needs more participants and not all patients were tested for HIV since it was not suitable for the local culture. High temperature which is involved in the cooking process could change the chemical properties of tempeh. Since physical activity consists of complex aspects, a combination of several tools can be used in a study to give a comprehensive view of interpretation.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Budhi Setiawan | Medical Faculty Wijaya Kusuma Surabaya | +6287751644522 | nehesa@gmail.com |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D001836 | Body Weight Changes |
| D009043 | Motor Activity |
| D001835 | Body Weight |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D015431 | Weight Loss |
| D013851 | Thinness |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D007538 | Isoniazid |
| D011718 | Pyrazinamide |
| D004977 | Ethambutol |
| D045730 | Soy Foods |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011719 | Pyrazines |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D000074421 | Fermented Foods |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D005502 | Food |
| D019602 | Food and Beverages |
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| >=65 years |
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| Male |
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| Madurese |
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| Others |
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| Others |
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| Middle School |
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| High school |
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| Bachelor |
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| Between one to three |
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| More than three |
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| Part timer |
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| Private |
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| Negative |
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| OG001 | Control | TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets Rifampicin Isoniazid Pyrazinamide Ethambutol |
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