Table 1. Randomization baseline data on demographic, clinical, COVID related timelines, laboratory variables, and Standard of Care (SOC) drugs in the study groups.
| VARIABLES | AYUSH Plus (n = 69) | SOC (n = 70) | P-value* |
|---|---|---|---|
| Clinical | |||
| Age (years) Mean ± SD | 42.87 ± 12.6 | 42.7 ± 12.0 | 0.93 |
| Male–number (%) | 54 (77.14%) | 58 (82.85%) | 0.52 |
| Body Weight (kg) Mean ± SD | 69.34 ±10.3 | 68.38 ±12.1 | 0.61 |
| BMI (kg/m2) Mean ± SD | 24.86 ±3.4 | 24.53 ±3.7 | 0.65 |
| Symptom onset to randomization (days), mean ± SD | 7.61 ±4.8 | 7.83 ± 4.5 | 0.51 |
| Symptom onset to Hospitalization, mean ± SD | 6.4 ± 4.64 | 6.5 ± 4.47 | 0.75 |
| Hospitalization to Randomization, mean ± SD | 1.4 ± 0.8 | 1.5 ± 0.9 | 0.55 |
| Mild clinical disease number (%) | 56 (80) | 58 (82.9) | 0.82 |
| Moderate clinical disease number (%) | 14 (20) | 12 (17.1) | 0.82 |
| Hypertension number (%) | 17 (24.29) | 10 (14.29) | 0.19 |
| Diabetes mellitus-number (%) | 14 (20) | 06 (8.57) | 0.09 |
| Undiagnosed hyperglycemia-number (%) | 9 (12.85) | 14 (20) | 0.36 |
| Blood sugar level mg/dl, mean ± SD | 112.50 ± 37.5 | 114.17 ± 35.2 | 0.74 |
| ESR mm fall 1st hour, mean ± SD | 50.2 ± 38.0 | 46.9 ± 37.4 | 0.79 |
| Blood hemoglobin gm/dl, mean ± SD | 13.6 ± 1.42 | 13.8 ±1.62 | 0.51 |
| Total leucocyte count/cu mm, mean ± SD | 5920.7 ± 2008 | 6828.3 ± 2085 | 0.02 |
| Total Lymphocyte count/cu mm, mean ± SD | 32.31 ± 9.1 | 31.07 ± 09.6 | 0.34 |
| Symptoms at baseline-number of subjects (percent) | |||
| Fever | 53 (75.71%) | 45 (64.28%) | 0.10 |
| Sore throat | 46 (65.71%) | 53 (75.71%) | 0.24 |
| Cough | 54 (77.14%) | 54 (77.14%) | 0.87 |
| Dyspnea | 24 (34.28%) | 25 (35.71%) | 0.90 |
| Myalgia | 48 (68.57%) | 54 (77.14%) | 0.31 |
| Headache | 37 (52.85%) | 32 (45.71%) | 0.35 |
| Diarrhea | 11 (15.71%) | 12 (17.14%) | 0.85 |
| Ageusia | 19 (27.14%) | 19 (27.14%) | 0.96 |
| Anosmia | 13 (18.57%) | 14 (20%) | 0.86 |
| Drugs administered-number of subjects (percent) | |||
| Tab Azithromycin | 48 (70%) | 49 (70%) | 0.95 |
| Tab Doxycycline | 1(2%) | 0 | 0.31 |
| Tab HCQS | 29 (42%) | 24(34%) | 0.35 |
| Tab Zinc | 48(70%) | 42(60%) | 0.24 |
| Tab Vitamin C | 69 (100%) | 69(99%) | 0.32 |
| Tab Vitamin D 3 | 15(22%) | 18(26%) | 0.58 |
| Tab Pantoprazole | 66(96%) | 65(93%) | 0.73 |
| Tab Paracetamol | 59 (86%) | 55(79%) | 0.28 |
| Tab Cetirizine | 13(19%) | 15(21%) | 0.70 |
| Tab Ivermectin | 3 (4%) | 2 (2.9%) | 0.99 |
| Anti-coagulant | 13(18.8%) | 13(19%) | 0.97 |
| Oxygen intermittent (< 2 liters/min) | 9(13%) | 6 (9%) | 0.39 |
*Statistically significant (P<0.05)
NS Not statistically significant (P> = 0.05)
a. Student’s ‘t test (normative data) or Chi-Square statistic (categorical data)
b. Note- n: number of study participants; SD: standard deviation; AYUSH plus: AYUSH 64 + SOC; BMI: body mass index; ESR: erythrocyte sedimentation rate (Wintrobe method); Other comorbid disorders: hyperlipidemia (2), cardiac disorder (1), chronic lung disease (2), thyroid disorder (5), Allergic rhinitis (3), number of participants in parenthesis; See text for details