Table 3.
Baseline demographic and disease characteristics in the intention-to-treat population
| Characteristics of patients | Control | Trial | P |
| Sex | |||
| Male (%) | 104 (54) | 169 (53) | 0.934 |
| Female (%) | 88 (46) | 147 (47) | 0.927 |
| Age-yr median(IQR 25th & 5th) | 35 (23.75-45) | 35 (27-45) | 0.229 |
| Weight (kg, mean ± SD) | 37.61 ± 5.94 | 38.32 ± 6.08 | 0.199 |
| Ethnicity (%)1 | |||
| Tribals | 171(89) | 287(91) | 0.883 |
| Others | 21(11) | 29(9) | 0.559 |
| Habits (%) | |||
| Smoking | 58 (30.2) | 103 (32.6) | 0.685 |
| Alcohol | 23 (12) | 33 (10.4) | 0.633 |
| Both | 26 (13.5) | 53 (16.7) | 0.403 |
| Socio-Economic status (%) | |||
| Upper-Middle | 20 (10.4) | 40 (12.6) | 0.499 |
| Middle | 30 (15.6) | 52 (16.4) | 0.833 |
| Lower | 142 (74) | 224 (71) | 0.763 |
| Pulmonary (%)2 | |||
| Open cases (sputum +ve) | 67 (35) | 137 (43.4) | 0.214 |
| Parenchymal | 152 (79.2) | 258 (81.6) | 0.822 |
| Cavitary | 18 (9.4) | 66 (21) | 0.003 |
| Effusion | 9 (4.6) | 20 (6.3) | 0.464 |
| Fibrosis | 27 (14) | 68 (21.5) | 0.081 |
| Extra pulmonary (%)2 | |||
| Cervical lymph node | 18 (9.4) | 31 (9.8) | 0.883 |
| Abdominal | 4 (2.1) | 6 (2) | 0.886 |
| Laryngeal | 7 (3.6) | 11 (3.5) | 0.925 |
| Central nervous system | 6 (3.1) | 6 (2) | 0.389 |
| Bones/Joints | 10 (5.2) | 19 (6) | 0.72 |
| Skin | 0 | 3 (1) | 0.598 |
| Genito-Urinary | 2 (1.04) | 1 (0.3) | 0.304 |
| Type of case (%) | |||
| New | 140 (73) | 195 (61.7) | 0.245 |
| Relapse | 43 (22.4) | 97 (30.7) | 0.122 |
| Chronic | 9 (4.7) | 24 (7.6) | 0.225 |
| Hematology | |||
| Hb (%) | 8.84 ± 1.93 | 8.95 ± 1.95 | 0.808 |
| Total leucocyte count/mm3 | 10 179 ± 4 680 | 9575 ± 4075 | 0.478 |
| ESR | 66.79 ± 30.64 | 70.49 ± 27.91 | 0.517 |
| Liver Function (mean, 95%CI) | |||
| Serum bilirubin | 1.07 (0.7-1.3) | 1.09 (0.8-1.4) | 0.952 |
| AST | 34.35 (17-63) | 32.4 (11-61) | 0.658 |
| ALT | 27.45 (9-57) | 31.15 (6-52) | 0.655 |
| ALP | 100 (50-260) | 107 (50-260) | 0.092 |
Unless stated otherwise, P values were calculated with the use of a two sided t-test with Welch’s modification (when unequal variance) for continuous data and a χ2 test for categorical data.
1
Ethnic group was assessed by investigation on screening. Tribal consists of Chaudhari, Gamit, Vasava, Bhil, Valvi, Nayka and Halpati.
2
Patients may belong to more than one category. ALP: Alkaline phosphatase.