#TITLE_ALTERNATIVE#

• Main Author: Febrina (NIM:207 05 012), Ellin
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/6033
• Institution: Institut Teknologi Bandung

Abstrct: <br /> <br /> <br /> <br /> <br /> <br /> <br /> Pulmonary tuberculosis (TB) treatment takes a long periode, at least six months. A previous clinical trial on new pulmonary tuberculosis patients of Acid Fast Bacilli (AFB)-positive with an addition to the standard treatment combination of red ginger rhizome and noni extracts showed that a combination of extracts at a ratio of 1:1 in the daily dose of 1 g at intensive phase could fasten the conversion of microbial sputum significantly than those of the daily dose of 0.5 g as well as the control. Therefore, this study was aimed to evaluate the efficacy and safety of those combination of extracts in tuberculosis treatment at intensive and advanced phases. <br /> <br /> <br /> <br /> <br /> <br /> <br /> The design of the study was randomized, double blind and placebo controlled method. The inclusion criteria in this study were new pulmonary tuberculosis of first category with AFB-positive, male or female of age of 18-55 years, no other disease, and willing to participate in the study. Those who only met inclusion criteria were 92 patients, divided into three groups: the group I received a combination of extracts at a ratio of 1:1 in the daily dose of 1 g, the group II received a combination of extract at a ratio of 1:1 in the daily dose of 0.5 g and the group III as control group received placebo. All patients receiving a standard antituberculosis regimen therapy for the tuberculosis patient of first category. The observed parameters consisted of body weight, Karnofsky score (general appearance), score of certain symptoms, score of microbial sputum, hematological parameters (haemoglobin, leucocytes, thrombocytes, erythrocyte sedimentation rate (ESR), blood glucose, SGOT, SGPT, creatinin, Prothrombin Time (PT), and Activated Partial Thromboplastin Time (APTT)). Observation was performed <br /> <br /> <br /> <br /> <br /> <br /> <br /> every two weeks for two months (intensive phase) and every month for four months (advanced phase). <br /> <br /> <br /> <br /> <br /> <br /> <br /> The results showed that the score of the microbial sputum of the group receiving an addition of combination of extracts at a ratio of 1:1 in the daily dose of 1 g and 0.5 g was different to that of the placebo group since second week but unsignificant. The significant different to the placebo group was happen at eighth week of observation (p<0,01 dan p<0,01). Clinically, body weight and score of certain symptoms of all groups underwent improvement since second week but unsignificant (p>0,05). The Karnofsky score of the group of the daily dose of 1 g and 0.5 g were significantly different to that of the placebo group at second week until eighth weeek (p<0,05). The combination of extracts have no influence on laboratory parameters, liver function, renal function and blood coagulation time. The most adverse event observed in all groups was itching; nine patients in the group of the daily dose of 1 g, seven patients in the group of the daily dose of 0.5 g, and eight patients in the group of placebo. Adverse events observed in the groups with a combination of extracts unsignificantly different than that of placebo group. <br />