Table 5. Adverse events (AE) in the two study groups* (n = 139).
| Adverse Events | AYUSH plus (n = 69) | OC (n = 70) | |||
|---|---|---|---|---|---|
| Participant | Events | Participant | Events | ||
| Summary | |||||
| Total | 28 | 48 | 29 | 48 | |
| Mild | 14 | 27 | 14 | 33 | |
| Moderate | 12 | 19 | 13 | 14 | |
| Severe | 2 | 2 | 2 | 2 | |
| Serious AE | 1 | 1 | 2 | 2 | |
| Causality | |||||
| Unrelated | - | 45 | - | 47 | |
| Unlikely | - | 03 | - | 2 | |
| AE is classified according to System Organ Classification and Preferred Term/Diagnosis (according to the investigator) | |||||
| Cardiac | 1 | 1 | 0 | 0 | |
| Transient hypertension | 1 | 1 | 0 | 0 | |
| Ear and labyrinth | 0 | 0 | 1 | 1 | |
| Ear ache | 0 | 0 | 1 | 1 | |
| GIT | 10 | 10 | 5 | 5 | |
| Gastritis | 0 | 0 | 1 | 1 | |
| Dyspepsia | 1 | 1 | 1 | 1 | |
| Diarrhea | 4 | 4 | 1 | 1 | |
| Constipation | 2 | 2 | 1 | 1 | |
| Epigastric pain | 1 | 1 | 0 | 0 | |
| Vague pain | 0 | 0 | 1 | 1 | |
| Hyperacidity | 2 | 2 | 0 | 0 | |
| Hepatic | 1 | 1 | 0 | 0 | |
| Transaminitis | 1 | 1 | |||
| Infections & infestations | 5 | 6 | 6 | 9 | |
| Episodic Fever | 5 | 5 | 2 | 2 | |
| Malaria | 0 | 0 | 2 | 2 | |
| Cellulitis | 0 | 0 | 1 | 1 | |
| Sore throat | 1 | 1 | 3 | 4 | |
| Skin | 2 | 2 | 1 | 1 | |
| Itch | 1 | 1 | 0 | 0 | |
| Eczema | 1 | 1 | 0 | 0 | |
| Non-specific | 1 | 1 | |||
| Respiratory | 6 | 7 | 7 | 8 | |
| Cough | 1 | 1 | 2 | 2 | |
| Episodic Breathlessness | 5 | 6 | 4 | 5 | |
| Non-specific | 0 | 0 | 1 | 1 | |
| Nervous system | 3 | 3 | 0 | 0 | |
| Neuropathy | 1 | 1 | 0 | 0 | |
| Vertigo | 2 | 2 | 0 | 0 | |
| Renal | 0 | 0 | 1 | 1 | |
| Dysuria | 0 | 0 | 1 | 1 | |
| Endocrine | 6 | 6 | 6 | 6 | |
| Hyperglycemia | 6 | 6 | 6 | 6 | |
| Investigation (Laboratory) | 0 | 0 | 1 | 1 | |
| Hyperlipidemia | 0 | 0 | 1 | 1 | |
| Others | 12 | 13 | 12 | 15 | |
| Weakness | 2 | 2 | 5 | 6 | |
| Chills | 0 | 0 | 1 | 1 | |
| Myalgia | 5 | 6 | 6 | 8 | |
| Arthralgia | 2 | 2 | 0 | 0 | |
| Headache | 3 | 3 | 0 | 0 | |
(1) Abbreviations: AYUSH Plus: AYUSH 64 plus Standard of Care (SOC); n: number of participants; GIT: gastrointestinal
(2) Clinical grading as per WHO classification
(3) Causality in the AYUSH plus pertained to AYUSH 64 drug while causality in the SOC arm was not specified to any particular drug
(4) Transaminitis: raised serum glutamic oxalacetate and or pyruvate
(5) No AE recorded for Disorders of blood and lymphatic, immune system, metabolism and nutrition, psychiatric, reproductive system and breast, eye, vascular system, congenital familial and genetic, injury poisoning and procedural complications, and surgical and medical procedures
(6)See Text and S6 File for further detail