Nature and mechanism of immune boosting by Ayurvedic medicine: A systematic review of randomized controlled trials

Table 1 Baseline study characteristics, and summary of risk of bias assessment

No	Ref.	Country of 1st author	Type of randomized controlled trial	Patient profile	Intervention1			Comparator1			Overall risk of bias as per RoB-2 tool2
					Sample size	Mean age	Male (N, %)	Sample size	Mean age	Male (N, %)
1	Enesel et al[18], 2005	Romania	Parallel group	Patients undergoing surgery for GIT cancer	40	62 (range 37-87)	23 (57.5)	30	NA	NA	-
2	Ishikawa et al[21], 2006	Japan	Parallel group	Patients with inoperable colon/liver/pancreatic cancer	25	63.6 ± 8.3	21 (84)	25	65.8 ± 6.3	18 (72%)	?
3	Brush et al[22], 2006	United States	Parallel group	Healthy adult volunteers	3	NA	NA	2	NA	NA	-
4	Schink et al[27], 2007	Germany	Parallel group	Primary/locally relapsed colorectal carcinoma patients undergoing open (complete/partial) tumour resection	11	72 ± 8.2	7 (63.6)	11	69 ± 10.4	5 (45.5)	?
5	Purandare et al[33], 2007	India	Parallel group	Patients with diabetic foot ulcer	23	56.26	17 (73.9)	22	56.32	19 (86.4)	?
6	Uebaba et al[29], 2008	Japan	Crossover	Healthy adult female volunteers	16	39 ± 9	0 (0)	16	39 ± 9	0 (0)	?
7	Bhat et al[28], 2010	India	Parallel group (I)	Healthy adult volunteers	13	NA	NA	13	NA	NA	?
			Crossover (II)	Healthy adult volunteers	110	NA	NA	110	NA	NA	-
8	Işik et al[23], 2010	Turkey	Parallel group	Allergic rhinitis patients with house dust mite sensitivity	12	NA	NA	12	NA	NA	-
9	Kianbakht et al[30], 2011	Iran	Parallel group	Healthy adult male volunteers	45	22.5 ± 0.6	45 (100)	44	21.1 ± 0.5	44 (100)	?
10	Mondal et al[24], 2011	India	Crossover	Healthy adult volunteers	22	NA	NA	22	NA	NA	?
11	Nantz et al[26], 2012	United States	Parallel group	Healthy adult volunteers	56	25.4 ± 5.7	23 (41.1)	56	26.9 ± 7.1	26 (46.4)	?
12	Suprabha et al[32], 2017	India	Parallel group	Uncomplicated pregnant women in 20-24 wk of pregnancy	15	NA	NA	15	NA	NA	?
13	Gupta et al[34], 2017	India	Parallel group	Healthy children aged 5-12 yr	313	7.3 ± 1.8	161 (51.4)	314	7.4 ± 1.8	164 (52.2)	?
14	Rais et al[36], 2021	India	Parallel group	25-60 yr, asymptomatic/ uncomplicated COVID-19 RTPCR +ve, mild symptoms	80	NA	57 (71.3)	40	NA	30 (75)	-
15	Bhaskaran et al[31], 2019	India	Parallel group	Healthy full-term infants (< 12 mo age), > 2.5 kg birth weight, with normal growth and development	47	NA	NA	34	NA	NA	-
16	Kumar et al[35], 2014	India	Parallel group	Adult patients with T2DM of any stage	56	NA	NA	28	NA	NA	-
17	Ravindran et al[25], 2014	India	Parallel group	Patients with head & neck cancer in complete remission following primary treatment	37	NA	NA	38	NA	NA	?
18	Somarathna et al[20], 2010	India	Parallel group	HIV +ve patients without AIDS surveillance signs as per WHO, and no concurrent illness	21	NA	NA	6	NA	NA	-
19	Gupta et al[19], 2010	India	Parallel group	New HIV +ve patients with CD4 count not < 150/microliter and no complications or comorbidities	12	NA	NA	8	NA	NA	-

¹Not all studies had reported demographics of participants including age and sex.

²Separate versions of RoB-2 were used for RCTs with parallel group design and crossover design. Interpretation: ?: Some concerns of bias; -: High risk of bias. Detailed risk of bias assessment results: Supplementary Table 4. HIV: Human immunodeficiency virus; NA: Not available; GIT: Gastrointestinal tract; COVID-19: Coronavirus disease 2019; RTPCR: Reverse transcription polymerase chain reaction.