Table 1. Characteristic of included studies.
| Author (Publish year) | Study design | Sample size (Drop-outs) | Patient’s characteristics | WS Form/ Route/ Daily dose | Control | Duration (follow up interval) | Outcomes of interest | Conclusion of effect WS on sleep | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Health status | Mean age (SD) | Sleep outcomes | Other outcomes | |||||||
| Salve et al (2019) | Randomize, DB, PC | I1: 19 (1) I2: 20 (0) C:19 (1) | Stressed healthy adults (PSS ≥20) | I1: 29.65 (6.36) | I1: Root extract in capsule (KSM-66)/ Oral/ 250 mg | Placebo capsule (starch power) | 8 weeks (week 4, 8) | SQS | HAMA-A | Beneficial |
| I2: 32.70 (8.79) | ||||||||||
| C: 30.35 (6.50) | ||||||||||
| I2: Root extract in capsule (KSM-66)/ Oral/ 600 mg | ||||||||||
| Langade et al (2019) | Randomize, DB, PC | I: 39 (1) | Insomnia (DSM-IV) | I: 38.83 (5.00) | Root extract in capsule (KSM-66)/ Oral/ 600 mg | Placebo capsule (starch power) | 10 weeks (week 5, 10) | SQS, PSQI, SOL, TST, WASO, TIB, Sleep efficiency | Mental alertness scale, HAM-A | Beneficial |
| C: 19 (1) | C: 40.00 (6.21) | |||||||||
| Kelgane et al (2020) | Randomize, DB, PC | I: 19 (6) | Healthy elderly adults | I: 72.16 (4.36) | Root extract in capsule (KSM-66)/ Oral/ 600 mg | Placebo capsule (starch power) | 12 weeks (week 4, 8, 12) | SQS | Mental alertness scale, QoL | Beneficial |
| C: 20 (5) | C: 70.70 (4.47) | |||||||||
| Deshpande et al (2020) | Randomize, DB, PC | I: 71 (4) | Healthy adults | I: 36.8 (10.98) | Root and leave extract in capsule (Shoden®)/ Oral/ 120 mg | Placebo capsule (rice powder) | 6 weeks (week 6) | SOL, TST, WASO, TIB, Sleep efficiency | QoL | Beneficial |
| C: 73 (2) | C: 37.61 (10.32) | |||||||||
| Langade et al (2021) | Randomize, DB, PC | I: 18 (2) | P1: Healthy | I: 35.60 (8.74) | Root extract in capsule (KSM-66)/ Oral/ 600 mg | Placebo capsule (starch power) | 8 weeks (week 1, 4, 8) | SQS, PSQI, SOL, TST, WASO, TIB, Sleep efficiency | Mental alertness scale, HAM-A | Beneficial |
| C: 18 (2) | adults | C: 38.25 (7.83) | ||||||||
| I: 20 (0) | P2: Insomnia | I: 38.70 (7.15) | ||||||||
| C: 17 (3) | (DSM-IV) | C: 35.95 (5.49) | ||||||||
C- Control group, DB- Double-blind, DSM- Diagnostic and Statistical Manual, HAMA-A- Hamilton-Anxiety scale, I- Intervention, PC- Placebo control, PSQI- Pittsburgh sleep quality index, P- population, QoL- Quality of life, SD- Standard deviation, SOL- Sleep Onset Latency, SQS- Sleep Quality Scale, TIB- Total Time In Bed, TST- Total Sleep Time, WASO- Wake Time After Sleep Onset, WS- Withania somnifera