Procedures and measures
fatigue, anxiety
ADVERSE EVENT
The assessment of general physical and mental health, psychosocial health, and quality of life (QOL) were carried out by using the standard World Health Organization QOL BREF questionnaire and a recently developed Health-Related-Behavior Habit and Fitness Questionnaire (HR-BHF CRD, Pune 2020 version) [The WHO QOL-BREF had 27 questions classified into 4 domains- physical health (7–35), psychological health (6–30), social relationships (3–15), and environmental well-being (8–40); the range of score is shown in parenthesis.HR-BHF contained nine questions pertaining to general health, anxiety, fatigue, energy level, bowel habits, stress, happiness, sleep, and appetite (food). Individual question score (0–100) and the total score (0–900) was used for analysis in the current study.Standard procedures were used to classify, monitor, record, and assign causality, in the case of an adverse event (AE, System organ classification, clinical grade of severity, preferred terms for recording signs, symptoms, and diagnosis). Guidelines published by ICH-GCP, ICMR (India), MedDRA, and WHO were also followed [Clinical evaluation included a routine physical and systemic examination. Both the clinical and laboratory evaluation was carried out several pre-determined study time points which included randomization baseline and study completion (