{
  "abstract": "Anxiety disorders are the most common mental disorders worldwide, affecting more than 359 million people. The COVID-19 pandemic is projected to increase the global prevalence of anxiety and depression by approximately 25%. Despite this significant burden, a notable treatment gap persists globally across high-income and low- and middle-income countries. The present study aimed to evaluate the safety and efficacy of Ashwagandha caplet in reducing the signs and symptoms of patients with mild to moderate stress and anxiety disorders. Patients (n=226) with mild to moderate stress and anxiety were assessed using the Hamilton Anxiety Rating Scale (HAM-A) and the Perceived Stress Scale (PSS-10) and randomized to receive either Ashwagandha caplet (n=112) or placebo caplet (n=114) once a day after food preferably at night for 8 weeks in a double-blind fashion. Reduction in HAM-A and PSS-10 scores were considered the primary outcomes, while improvements in mental well-being, fatigue, and safety evaluations were considered secondary outcomes. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed for all efficacy parameters. Ashwagandha caplet showed statistically significant (p<0.0001) improvement in stress (PSS-10), anxiety (HAM-A), and mental well-being (General Health Questionnaire-12) in patients with mild to moderate stress and anxiety compared to placebo by both ITT and PP analyses. Superiority analysis (as per USFDA guidelines) further indicated that the effect of Ashwagandha caplet was superior to placebo in reducing stress (PSS-10) and anxiety (HAM-A) in both the ITT and PP analyses. No drug- related or serious adverse events were reported throughout the study. Ashwagandha caplet once a day for 8 weeks proved to be effective, safe, and superior to placebo in the management of signs and symptoms in patients suffering from mild to moderate stress and anxiety.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Psychiatry, University of Texas, Houston, TX, USA.",
    "Department of Psychiatry, Central Prison Hospital, Department of Health and Family Welfare, Government of Karnataka, Bengaluru, KA, India.",
    "Department of Psychiatry, Bangalore Medical College and Research Institute, Bengaluru, KA, India.",
    "Department of Psychiatry, KJ Somaiya Medical College and Research Center, Mumbai, MH, India.",
    "Department of Psychiatry, The Mind Clinic, Chennai, TN, India.",
    "Department of Psychiatry, Interdisciplinary Institute of Indian System of Medicine (IIISM), SRM Institute of Science & Technology, Chennai, TN, India.",
    "Department of Psychiatry, Gangoshri Hospital, Varanasi, UP, India.",
    "Research & Development Centre, Himalaya Wellness Company, Bengaluru, KA, India.",
    "Medical Services & Clinical Development, Himalaya Wellness Company, Bengaluru, KA, India."
  ],
  "article_type": "case report",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Prashant Gajwani",
      "orcid": "0009-0005-6158-1667"
    },
    {
      "affs": [
        1
      ],
      "name": "Santhosh J",
      "orcid": "0009-0001-8930-2878"
    },
    {
      "affs": [
        2
      ],
      "name": "Chillal Guru Prasad",
      "orcid": "0000-0003-1907-7107"
    },
    {
      "affs": [
        3
      ],
      "name": "Veena Sagar Gholap",
      "orcid": "0009-0008-3284-4415"
    },
    {
      "affs": [
        4
      ],
      "name": "Sai Balasubramanian Dheenadhayalan",
      "orcid": "0000-0001-8098-0915"
    },
    {
      "affs": [
        5
      ],
      "name": "Satish Kumar Rajappan Chandra",
      "orcid": "0000-0002-6786-5880"
    },
    {
      "affs": [
        6
      ],
      "name": "Pradeep Chaurasia",
      "orcid": "0009-0001-4645-9314"
    },
    {
      "affs": [
        7
      ],
      "name": "U V Babu",
      "orcid": "0009-0002-3596-5390"
    },
    {
      "affs": [
        8
      ],
      "name": "Rajesh Kumawat",
      "orcid": "0000-0001-9304-646X"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/bkwpvfbsqtjzj.bib",
  "cited_by": 0,
  "doi": "10.2147/ndt.s633019",
  "fulltext_url": "https://europepmc.org/articles/PMC13715648",
  "id": "bkwpvfbsqtjzj",
  "issns": [
    "1176-6328",
    "1178-2021"
  ],
  "landing_url": "https://europepmc.org/article/MED/42953409",
  "language": "eng",
  "licence": "CC-BY-NC",
  "licence_label": "CC BY-NC",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Clinical Trial Report"
    ],
    [
      "openalex",
      "2707|Phytochemicals and Medicinal Plants"
    ]
  ],
  "openalex": "W7223400747",
  "pdf_url": "https://europepmc.org/articles/PMC13715648?pdf=render",
  "pmcid": "PMC13715648",
  "pmid": "42953409",
  "published": "2026-10-24",
  "publisher": "Dove Press",
  "ris": "https://research.draconitic.com/paper/bkwpvfbsqtjzj.ris",
  "sources": [
    {
      "first_seen": "2026-10-31T00:20:40Z",
      "native_id": "MED:42953409",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42953409"
    },
    {
      "first_seen": "2026-11-01T12:22:53Z",
      "native_id": "PMC13715648",
      "source": "pmc",
      "url": "https://doi.org/10.2147/ndt.s633019"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2707|Phytochemicals and Medicinal Plants",
      "subfield": "general"
    }
  ],
  "title": "Evaluation of the Efficacy and Safety of Ashwagandha Caplet in Patients Suffering from Mild to Moderate Stress and Anxiety Disorders: A Multicentric, Double-Blind, Randomized, Placebo-Controlled, Clinical Trial.",
  "title_text": "Evaluation of the Efficacy and Safety of Ashwagandha Caplet in Patients Suffering from Mild to Moderate Stress and Anxiety Disorders: A Multicentric, Double-Blind, Randomized, Placebo-Controlled, Clinical Trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:22:53Z",
  "url": "https://research.draconitic.com/paper/bkwpvfbsqtjzj",
  "venue": "Neuropsychiatric disease and treatment",
  "versions": []
}