| CTRI Number |
CTRI/2026/01/100536 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Assess the Safety and Effectiveness of Kava Extract in Adults with Stress and Anxiety |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Trial of Kava Extract (KavasoulTM) in Adults: Effects on Stress and Anxiety. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHAR-CT-KA-11//25 Version 01 dated 08 Dec 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Praveen Kumar |
| Designation |
Consultant Cardiologist(Non Invasive) |
| Affiliation |
Samiksha Heart And Diabetic Care |
| Address |
1226, 8th B Cross Rd, Yelahanka Satellite Town, Yelahanka, Bengaluru, Karnataka 560064
Bangalore
KARNATAKA
560064
India |
| Phone |
9379059060 |
| Fax |
|
| Email |
praveen.j.seth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baburao Vikram |
| Designation |
Director |
| Affiliation |
Pharexcelconsulting private Limited |
| Address |
15093, Tata New Haven, Seshagirirao Palya Village, Dasanpura Hobli, Near The Golden Palms Hotel & Spa Bengaluru North Taluka, Karnataka
Bangalore
KARNATAKA
562123
India |
| Phone |
9878551428 |
| Fax |
|
| Email |
info@pharexcelconsulting.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HN Shivaprasad |
| Designation |
Chief Scientific Officer |
| Affiliation |
Botanic Healthcare Private limited |
| Address |
Plot No. 16,1,12,13, TSIIC IDA, Nacharam, Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076
Hyderabad
TELANGANA
500076
India |
| Phone |
9515222461 |
| Fax |
|
| Email |
shiv@botanichealthcare.net |
|
|
Source of Monetary or Material Support
|
| Botanic Healthcare Pvt. Ltd
Plot No. 16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076 |
|
|
Primary Sponsor
|
| Name |
Botanic Healthcare Pvt. Ltd |
| Address |
Plot No. 16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076 |
| Type of Sponsor |
Other [Nutraceutical Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Botanic Healthcare Pvt Ltd |
Plot No. 16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Praveen Kumar |
Samiksha Heart and Diabetic Care |
Room no 1, Ground floor, 1226, 8th B Cross Rd, Yelahanka Satellite Town,
Yelahanka, Bengaluru, Karnataka 560064
Bangalore
KARNATAKA |
9379059060
praveen.j.seth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pharexcel Independent Ethics Committee Pharexcel Consulting Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kava Extract (KavasoulTM) |
150mg(One capsule/day in Morning after Breakfast) for 6 weeks. |
| Comparator Agent |
Placebo |
identical in appearance to the investigational product |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in HAM-A score
2. Change in PSS-14 score |
Day 0, Day 30, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in Depression Anxiety Stress Scale (DASS-21) scores |
Day 0, Day 30, Day 45, |
| 2. Change in Leeds Sleep Evaluation Questionnaire (LSEQ) scores |
Day 0, Day 30, Day 45, |
| 3.Change in blood pressure and heart rate |
Day 0, Day 30, Day 45, Day 52 |
| 4. Change in biomarkers: GABA, and glutamate/glutamine ratio |
Day 0, Day 45 |
| 5. Change in Biomarker Cortisol |
Day 0, Day 45, Day 52 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
15/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single-centre, randomized, double-blind, placebo-controlled clinical study designed to evaluate the effectiveness and safety of Kava extract (Kavasoul™) in adults experiencing mild to moderate stress and anxiety. A total of 40 eligible participants aged 18 to 65 years will be randomly assigned to receive either Kava extract (150 mg per day) or a placebo for a period of 6 weeks. The primary aim of the study is to assess whether Kava extract reduces stress and anxiety levels compared to placebo. Stress and anxiety will be evaluated using validated questionnaires, including the Hamilton Anxiety Rating Scale (HAM-A) and the Perceived Stress Scale (PSS-14). Secondary objectives include assessing changes in mood, sleep quality, vital signs, and selected blood biomarkers related to stress and neurotransmitter balance. Participants will attend study visits at baseline, during treatment, at the end of treatment, and during a short follow-up period. Safety will be monitored throughout the study by recording adverse events, vital signs, and laboratory test results, including liver function tests. The study will be conducted in accordance with Good Clinical Practice guidelines and ethical principles, and written informed consent will be obtained from all participants prior to participation. |