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Role of Ashwagandha in the management of Mild to Moderate Depression among adolescents

Effectiveness of Ashwagandha (Withania somnifera (L.) Dunal) In The Management Of Vishaada (Mild To Moderate Depressive Disorder) Among Adolescents: A Randomized Double Blind Placebo Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037967
Enrollment
114
Registered
2021-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: F330- Major depressive disorder, recurrent, mild Health Condition 2: F331- Major depressive disorder, recurrent, moderate

Interventions

None listed

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants showing signs of Mild to Moderate Depression as per DSM-V Criteria. (PHQ-9 score 5-14). Participants providing written informed consent of caretakers/parents. Participants providing written informed assent to participate in the study.

Exclusion criteria

Exclusion criteria: No Depression (PHQ- 9 score below or equals to 4) along with no other clinical manifestation. Severe Depression (PHQ- 9 score equal or above 15). Intelligent Quotient (IQ) Below 70 [Borderline Intelligence]. Any severe co-morbid psychiatric disorder, especially a diagnosis of bipolar disorder, schizophrenia, autism spectrum disorder, schizoaffective disorder or organic psychiatric disorder assessed by taking detailed history and examination. Any other medical or neurological conditions or any other illness interfering with interventions. Participants suffering from any systemic illness, history of epilepsy or chronic illness like hypo or hyperthyroidism. Substance use disorder or dependency, suicidal ideations. Current use of Anti-epileptics, anti-psychotic or psychotropic drugs (e.g., Selective Serotonin Reuptake Inhibitor, Serotonin and norepinephrine reuptake inhibitors etc.) and any other investigational drugs

Design outcomes

Primary

MeasureTime frame
Reduction in the PHQ-9 score.Timepoint: Before Treatment-After Treatment (8weeks)

Secondary

MeasureTime frame
Improvement in sleep quality of adolescents. Improvement in Clinical Global Impression Score. Improvement in the quality of life (QOL)Timepoint: Before Treatment-After Treatment (8weeks)

Countries

India

Contacts

Public ContactDR SONAM

All India Institute of Ayurveda (AIIA)

ayuarun@gmail.com8506821947

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026