Table 1.

Clinical assessment schedule.

Visit	Visit 0 Screening (Day −7 to −1)	Visit 1 Enrollment and randomization (Day 1)	Visit 2 (4 wks)	Visit 3:(8 wks)	Visit 4 (12 wks)		Visit 5:(16 wks)	Visit 6 Intervention completion1 (24 wks)	Visit 7: Study completion (28 wks)
Informed consent	X					Interim analysis
Demographics	X
Inclusion exclusion criteria	X
Medical history	X
Concomitant illness	X		X	X	X		X	X	X
Randomization		X
Complete physical examination	X	X	X	X	X		X	X	X
WHO QOL BREF@		X			X			X	X
HR-BHF#		X			X			X	X
Vital signs	X	X	X	X	X		X	X	X
Ayurvedic evaluation: prakriti		X
Ayurvedic evaluation: dhatu sarata		X	X	X	X		X	X	X
Ayurvedic evaluation:		X	X	X	X		X	X	X
Electrocardiogram	X							X
Chest radiograph	X							X
Study drug dispensation		X	X	X	X		X
Adverse event assessment			X	X	X		X	X	X
Mobile App–Kavach–self reported questionnaire*		X	X	X	X		X	X	X
Completion and outcome report									X

^*To be completed daily by participants.

^#HR-BHF: Health Related-Habits, Behavior and Fitness.

^@WHO QOL BREF: World Health Organization Quality of Life Instruments-short form.