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A Study to Assess the Safety and Effectiveness of Kava Extract in Adults with Stress and Anxiety

A Randomized, Double-Blind, Placebo-Controlled Trial of Kava Extract (KavasoulTM) in Adults: Effects on Stress and Anxiety. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100536
Enrollment
40
Registered
2026-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders

Interventions

Intervention1: Kava Extract (KavasoulTM): 150mg(One capsule/day in Morning after Breakfast) for 6 weeks. Control Intervention1: Placebo: identical in appearance to the investigational product

Sponsors

Botanic Healthcare Pvt. Ltd
Lead Sponsor
Botanic Healthcare Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 65 years 2.Experiencing mild to moderate stress or anxiety (PSS- 14 score greater than 19 and HAM-A score greater than 18) 3.Generally healthy, with no significant medical or psychiatric conditions affecting participation 4.Able to use a smartphone, tablet, or computer to complete study assessments 5.Willing and able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe psychiatric disorder (bipolar disorder, psychosis, major depression with suicidal ideation). 2. Use of anxiolytics, antidepressants, sedatives within 30 days. 3. Known liver disease or abnormal liver function tests. 4. Substance abuse within 6 months. 5. Pregnancy, lactation, or planning pregnancy. 6. Participation in any other clinical trial within 30 days. 7. Hypersensitivity to herbal products or study ingredients. 8. Any condition that may interfere with participation or data quality

Design outcomes

Primary

MeasureTime frame
1. Change in HAM-A score 2. Change in PSS-14 scoreTimepoint: Day 0, Day 30, Day 45—

Secondary

MeasureTime frame
1. Change in Depression Anxiety Stress Scale (DASS-21) scoresTimepoint: Day 0, Day 30, Day 45,;2. Change in Leeds Sleep Evaluation Questionnaire (LSEQ) scoresTimepoint: Day 0, Day 30, Day 45,;3.Change in blood pressure and heart rateTimepoint: Day 0, Day 30, Day 45, Day 52;4. Change in biomarkers: GABA, and glutamate/glutamine ratioTimepoint: Day 0, Day 45;5. Change in Biomarker CortisolTimepoint: Day 0, Day 45, Day 52—

Countries

India

Contacts

Public ContactDr HN Shivaprasad

Pharexcelconsulting private Limited

info@pharexcelconsulting.com9878551428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026