Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study

Langade, Deepak; Thakare, Vaishali; Kanchi, Subodh; Kelgane, Sunil B

doi:10.1016/j.jep.2020.113276

Cited by 36 publications

(60 citation statements)

References 45 publications

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“…Both sexes were included in all the trials. There was no baseline imbalance in demographic characteristics across the intervention and comparison groups in all five trials [45,[53][54][55][56].…”

Section: Characteristics Of Included Studiesmentioning

confidence: 95%

“…We included five trials with a total of 400 participants [45,[53][54][55][56]. Table 1 further describes the studies included.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…Out of the five trials, one trial declared that their study was partially sponsored by the manufacturer [45]. All trials were conducted in India [45,[53][54][55][56]. Three of the trials recruited participants from outpatient clinics [54][55][56], one trial recruited through phone call [45], and one trial did not mention the method of recruitment [53].…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…All trials were conducted in India [45,[53][54][55][56]. Three of the trials recruited participants from outpatient clinics [54][55][56], one trial recruited through phone call [45], and one trial did not mention the method of recruitment [53]. The five trials included in this meta-analysis comprised of two trials with 210 healthy adults [45,53], one trial with 50 healthy elderly over 60 years old [55], one trial with 60 adults diagnosed with insomnia based on DSM-IV [54], and one trial that included two groups of participants which were 40 healthy adults, and 40 adults diagnosed with insomnia based on DSM-IV [56].…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

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Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

et al. 2021

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Objective To determine the effect of Ashwagandha extract on sleep. Methods A comprehensive search was conducted in CENTRAL, MEDLINE, SCOPUS, Google Scholars, World Health Organization Trials Portal, ClinicalTrials.gov, Clinical Trial Registry of India, and AYUSH Research Portal for all appropriate trials. Randomized controlled trials that examined the effect of Ashwagandha extract versus placebo on sleep in human participants 18 years old and above were considered. Two authors independently read all trials and independently extracted all relevant data. The primary outcomes were sleep quantity and sleep quality. The secondary outcomes were mental alertness on rising, anxiety level, and quality of life. Results A total of five randomized controlled trials containing 400 participants were analyzed. Ashwagandha extract exhibited a small but significant effect on overall sleep (Standardized Mean Difference -0.59; 95% Confidence Interval -0.75 to -0.42; I2 = 62%). The effects on sleep were more prominent in the subgroup of adults diagnosed with insomnia, treatment dosage ≥600 mg/day, and treatment duration ≥8 weeks. Ashwagandha extract was also found to improve mental alertness on rising and anxiety level, but no significant effect on quality of life. No serious side effects were reported. Conclusion Ashwagandha extract appears to has a beneficial effect in improving sleep in adults. However, data on the serious adverse effects of Ashwagandha extract are limited, and more safety data would be needed to assess whether it would be safe for long-term use.

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Section: Characteristics Of Included Studiesmentioning

confidence: 95%

“…We included five trials with a total of 400 participants [45,[53][54][55][56]. Table 1 further describes the studies included.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

et al. 2021

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“…Deshpande et al showed improved sleep quality in healthy patients suffering from nonrestorative sleep after treatment with a standardized extract of ashwagandha [75]. In a recent clinical study, Langade et al verified the use of an extract of ashwagandha both as an anxiolytic and to improve symptoms of insomnia as compared to a placebo [76]. Taken together, these studies show that ashwagandha can be used as an anxiolytic, as well as for treating insomnia and enhancing sleep quality.…”

Section: Withania Somniferamentioning

confidence: 99%

Medicinal Plants for Insomnia Related to Anxiety: An Updated Review

2021

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Sleep disorders are common among the general population and can generate health problems such as insomnia and anxiety. In addition to standard drugs and psychological interventions, there are different complementary plant-based therapies used to treat insomnia and anxiety. This review aimed to find and examine the most recent research on the use of herbal medicines for treating anxiety and insomnia as compiled from clinical trials, as well as to assess the safety and efficacy of these medicines and to elucidate their possible mechanisms of action. The process entailed a search of PubMed, Scopus, and the Cochrane Library databases from 2010 to 2020. The search terms included “sleep disorder”, “insomnia”, “sedative”, “hypnotic”, “anxiety”, “anxiolytic”, and “clinical trial”, combined with the search terms “herbs” and “medicinal plants”, in addition to individual herbal medicines by both their common and scientific names. This updated review, which focuses mainly on clinical trials, includes research on 23 medicinal plants and their combinations. Essential oils and their associations have also been reviewed. The efficacy of medicinal plants depends on treatment duration, types of study subjects, administration route, and treatment method. More clinical trials with an adequate, standardized design are necessary, as are more preclinical studies to continue studying the mechanisms of action. As a result of our work, we can conclude that the 3 plants with the most potential are valerian, passionflower, and ashwagandha, with the combination of valerian with hops and passionflower giving the best results in the clinical tests.

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Effect of standardized root extract of ashwagandha (Withania somnifera) on well‐being and sexual performance in adult males: A randomized controlled trial

Chauhan

Srivastava²,

Pathak³

2022

Health Science Reports

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Background and Aim: In Ayurveda, ashwagandha is a popular plant for promoting youthful energy, longevity, and overall well-being. It is also an excellent aphrodisiac herb that aids in the improvement and maintenance of normal sexual health. The present study aims to evaluate the effect of ashwagandha root extract on improving sexual health in adult males.Methods: In this 8-week randomized, double-blind, placebo-controlled study, we investigated the aphrodisiac property of an ashwagandha root extract in adult males.Fifty participants with lower sexual desire were randomly allocated to take 300 mg of ashwagandha root extract or placebo capsules twice daily. Outcomes were measured using the derogatis interview for sexual functioning-male (DISF-M) questionnaire, serum testosterone, serum prolactin, and short-form survey-36 quality of life questionnaire before and after the intervention.Results: Compared to placebo, ashwagandha root extract supplementation was associated with a statistically significant increase in the total DISF-M scores (mean difference −9.8; 95% confidence interval, −10.73 to −8.87; p < 0.0001; t-test). It was also associated with a statistically significant increase in serum testosterone levels (−66.52; −80.70 to −52.34; p < 0.0001; t-test). However, the prolactin level did not change after intervention in both the ashwagandha and placebo groups (−1.06; −2.78 to 0.66; p > 0.05). Conclusion:These findings suggest that ashwagandha demonstrated a significant subjective perception of sexual well-being and assisted in increasing serum testosterone levels in the participants.

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Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study

Cited by 36 publications

References 45 publications

Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

Medicinal Plants for Insomnia Related to Anxiety: An Updated Review

Effect of standardized root extract of ashwagandha (Withania somnifera) on well‐being and sexual performance in adult males: A randomized controlled trial

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