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| Name | Class |
|---|---|
| Ministry of Health, Thailand | OTHER_GOV |
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This study was a randomized controlled trial studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin with pulmonary tuberculosis standard treatment group and placebo drug with pulmonary tuberculosis standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient receive metformin with pulmonary tuberculosis standard treatment. | Active Comparator | Patient receive pulmonary tuberculosis standard treatment: isoniazid, rifampicin, pyrazinamide, and ethambutol in first and second month(weight adjusted dose), then in third to sixth month switch tuberculosis standard treatment to isoniazid and rifampicin(weight adjusted dose). In all 6 months, patient receive metformin (500 mg) 1 tablet simultaneously. |
|
| Patient receive placebo drug with pulmonary tuberculosis standard treatment. | Placebo Comparator | Patient receive pulmonary tuberculosis standard treatment: isoniazid, rifampicin, pyrazinamide, and ethambutol in first and second month(weight adjusted dose), then in third to sixth month switch tuberculosis standard treatment to isoniazid and rifampicin(weight adjusted dose). In all 6 months, patient receive placebo drug 1 tablet simultaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetFORMIN 500 Mg Oral Tablet | Drug | studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients receive metformin with pulmonary tuberculosis standard treatment group in second week, second, fifth, and sixth month. |
| Measure | Description | Time Frame |
|---|---|---|
| To study about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin and placebo drug with pulmonary tuberculosis standard treatment. | patient will be collected sputum acid fast bacillus and sputum culture for tuberculosis in second week, second, fifth, sixth month. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To study about side effect such as nausea, vomit, hepatitis between patients use metformin with pulmonary tuberculosis standard treatment and patients use placebo drug with pulmonary tuberculosis standard treatment. | To compare incidence rate of side effect between patients use metformin with pulmonary tuberculosis standard treatment and patients use placebo drug with pulmonary tuberculosis standard treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angsana Phuphuakrat, MD, PhD | Contact | 6622011581 | angsana.phu@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angsana Phuphuakrat | Recruiting | Ratchathewi | ฺBangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25411472 | Background | Singhal A, Jie L, Kumar P, Hong GS, Leow MK, Paleja B, Tsenova L, Kurepina N, Chen J, Zolezzi F, Kreiswirth B, Poidinger M, Chee C, Kaplan G, Wang YT, De Libero G. Metformin as adjunct antituberculosis therapy. Sci Transl Med. 2014 Nov 19;6(263):263ra159. doi: 10.1126/scitranslmed.3009885. | |
| 29540054 | Background |
| Label | URL |
|---|---|
| Clinical Evaluation of Efficacy and Safety of Metformin add-on Therapy to Standard ATT in Newly Diagnosed Pulmonary Tuberculosis Patients | View source |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 |
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| Placebo | Drug | studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients receive placebo drug with pulmonary tuberculosis standard treatment group in second week, second, fifth, and sixth month. |
|
| 6 months |
| Lee YJ, Han SK, Park JH, Lee JK, Kim DK, Chung HS, Heo EY. The effect of metformin on culture conversion in tuberculosis patients with diabetes mellitus. Korean J Intern Med. 2018 Sep;33(5):933-940. doi: 10.3904/kjim.2017.249. Epub 2018 Mar 16. |
| 29325084 | Background | Degner NR, Wang JY, Golub JE, Karakousis PC. Metformin Use Reverses the Increased Mortality Associated With Diabetes Mellitus During Tuberculosis Treatment. Clin Infect Dis. 2018 Jan 6;66(2):198-205. doi: 10.1093/cid/cix819. |
| 31623569 | Background | Yu X, Li L, Xia L, Feng X, Chen F, Cao S, Wei X. Impact of metformin on the risk and treatment outcomes of tuberculosis in diabetics: a systematic review. BMC Infect Dis. 2019 Oct 17;19(1):859. doi: 10.1186/s12879-019-4548-4. |
| 23148156 | Background | Lashen H. Role of metformin in the management of polycystic ovary syndrome. Ther Adv Endocrinol Metab. 2010 Jun;1(3):117-28. doi: 10.1177/2042018810380215. |
| 30151735 | Background | Ning HH, Le J, Wang Q, Young CA, Deng B, Gao PX, Zhang HQ, Qin SL. The effects of metformin on simple obesity: a meta-analysis. Endocrine. 2018 Dec;62(3):528-534. doi: 10.1007/s12020-018-1717-y. Epub 2018 Aug 27. |
| 30797286 | Background | Novita BD, Ali M, Pranoto A, Soediono EI, Mertaniasih NM. Metformin induced autophagy in diabetes mellitus - Tuberculosis co-infection patients: A case study. Indian J Tuberc. 2019 Jan;66(1):64-69. doi: 10.1016/j.ijtb.2018.04.003. Epub 2018 Apr 17. |
| 25880846 | Result | Vashisht R, Brahmachari SK. Metformin as a potential combination therapy with existing front-line antibiotics for Tuberculosis. J Transl Med. 2015 Mar 7;13:83. doi: 10.1186/s12967-015-0443-y. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |