Study of Ashwagandha for Stress Anxiety and Sleep in Young Teens

Efficacy and Safety of KSM66 Ashwagandha (Withania somnifera) standardized root extract (450 mg) on Stress, Anxiety, and Sleep Quality in the Young Teens: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/05/111429

Enrollment

100

Registered

2026-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F411- Generalized anxiety disorder

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Parent reported concerns related to child stress, anxiety, or sleep disturbance. 2. Participants aged 13 to 19 years. 3. Participants with moderate to high perceived stress levels based on the Perceived Stress Scale score greater than 14. 4. Participants willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants with current psychiatric diagnosis such as major depressive disorder, bipolar disorder, or psychosis. 2. Participants using anti anxiety or sleep medication within the last 3 months. 3. Participants with known allergy or intolerance to Ashwagandha. 4. Participants who are pregnant or breastfeeding. 5. Participants with any chronic illness that may affect the study results such as severe insomnia or neurological disorders. 6. Participants with known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological, or neurological illnesses.

Design outcomes

Primary

Measure	Time frame
Mean Change in Perceived Stress Scale (PSS-10) scoresTimepoint: baseline, week 4, week 8.	—

Secondary

Measure	Time frame
Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline to week 8.Timepoint: Baseline, Week 8;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline to week 8.Timepoint: Baseline, Week 8;Mean change in Thyroid (T3, T4, TSH) parameters from baseline to week 8.Timepoint: Baseline, Week 8;Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.Timepoint: Baseline, Week 4, Week 8;Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.Timepoint: Baseline, Week 4, Week 8;Mean change in Screen for Child Anxiety Related Disorders (SCARED) scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean change in PANAS-C (Positive and Negative Affect Scale Children) scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean Change in Strengths and Difficulties Questionnaire (SDQ) Attention Subscale from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean change in Youth Self-Report (YSR) scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean change in KIDSCREEN-10 QoL scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Change in Bedtime cortisol levels from baseline to week 8.Timepoint: Baseline and Week 8;Change in Salivary Cortisol Awakening response (CAR) from baseline to Week 8.Timepoint: Baseline and Week 8	—

Measure

Time frame

Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline to week 8.Timepoint: Baseline, Week 8;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline to week 8.Timepoint: Baseline, Week 8;Mean change in Thyroid (T3, T4, TSH) parameters from baseline to week 8.Timepoint: Baseline, Week 8;Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.Timepoint: Baseline, Week 4, Week 8;Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.Timepoint: Baseline, Week 4, Week 8;Mean change in Screen for Child Anxiety Related Disorders (SCARED) scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean change in PANAS-C (Positive and Negative Affect Scale Children) scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean Change in Strengths and Difficulties Questionnaire (SDQ) Attention Subscale from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean change in Youth Self-Report (YSR) scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Mean change in KIDSCREEN-10 QoL scores from baseline to week 8.Timepoint: Baseline, Week 4, Week 8;Change in Bedtime cortisol levels from baseline to week 8.Timepoint: Baseline and Week 8;Change in Salivary Cortisol Awakening response (CAR) from baseline to Week 8.Timepoint: Baseline and Week 8

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Countries

India, United States of America

Contacts

Public ContactDr Sagar Mandlik

Vakratunda Hospital Pvt. Ltd.

sagarmandlik007@yahoo.com9225343885

Outcome results