CTRI

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CTRI Number

CTRI/2025/12/099333 [Registered on: 17/12/2025] Trial Registered Prospectively

Last Modified On:

17/12/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Nutraceutical

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A study to evaluate the effectiveness and safety of JOFP-001 capsules in reducing stress and anxiety in healthy adults.

Scientific Title of Study

A Randomized, Double Blind, Placebo Control study to assess the efficacy and safety of JOFP-001capsule versus placebo for the management of stress and anxiety in healthy adult subjects.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Janani Sankar
Designation	Senior Consultant Psychiatrist
Affiliation	Chennai Meenakshi Multispeciality Hospital
Address	Chennai Meenakshi Multispeciality Hospital Ltd. Old No 149, New No 70, Luz Church Road, Mylapore, Chennai-600004, Tamil Nadu, India Chennai TAMIL NADU 600004 India
Phone	9566229193
Fax
Email	clinsolve@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Janani Sankar
Designation	Senior Consultant Psychiatrist
Affiliation	Chennai Meenakshi Multispeciality Hospital
Address	Chennai Meenakshi Multispeciality Hospital Ltd. Old No 149, New No 70, Luz Church Road, Mylapore, Chennai-600004, Tamil Nadu, India TAMIL NADU 600004 India
Phone	9566229193
Fax
Email	clinsolve@gmail.com

Details of Contact Person
Public Query

Name	Dr Janani Sankar
Designation	Senior Consultant Psychiatrist
Affiliation	Chennai Meenakshi Multispeciality Hospital
Address	Chennai Meenakshi Multispeciality Hospital Ltd. Old No 149, New No 70, Luz Church Road, Mylapore, Chennai-600004, Tamil Nadu, India TAMIL NADU 600004 India
Phone	9566229193
Fax
Email	clinsolve@gmail.com

Source of Monetary or Material Support

Jeeva Organic Private Limited DLF Cybercity, DCB-705, 7th Floor Infocity Ave, Patia, Bhubaneswar Odisha 751024

Primary Sponsor

Name	Jeeva Organic Private Limited
Address	Jeeva Organic Private Limited, DLF Cybercity, DCB-705, 7th Floor, Infocity Ave, Patia, Bhubaneswar, Odisha 751024
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Janani Sankar	Chennai Meenakshi Multispeciality Hospital Limited	Clinical research department, Basement, Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu, 600004, India Chennai TAMIL NADU	09566229193 clinsolve@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Chennai Meenakshi Multispeciality Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Individuals with mild to moderate stress and/or anxiety

Intervention / Comparator Agent

Type	Name	Details
Intervention	JOFP-001	JOFP-001 is a 300 mg standardized ashwagandha based capsule to be taken once daily after food at night for 60 days.
Comparator Agent	Placebo	Matching placebo 300 mg capsule identical in appearance, size, and color; contains inert excipients only. to be taken once daily after food at night for 60 days.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Adults aged 18 to 65 years. 2. Individuals with mild to moderate stress and/or anxiety, as defined by: A Perceived Stress Scale (PSS) score greater than or equal to 14 and smaller than or equal to 26. A DASS-21 anxiety score between 08 and 14 with self-reported fatigue, insomnia, loss of appetite, and concentration. 3. Willing and able to provide written informed consent and comply with all study procedures. 4. Female, participants must be non-pregnant, non-lactating, and either postmenopausal or using an acceptable form of contraception (such as birth control pills, IUDs, or condoms) during the study. 5. Participants must have a stable lifestyle (such as no major changes in diet, exercise routine, or work schedule during the study period). 6. Participants must demonstrate normal vital signs and baseline laboratory values (such as liver function tests, kidney function tests, and electrolyte levels) as assessed during the screening process. 7. Participants must agree to avoid using other adaptogenic herbs, anti-anxiety medications, or supplements that could interfere with the study’s outcomes.

ExclusionCriteria

Details

1. Diagnosis of major depressive disorder, bipolar disorder, schizophrenia, or any other psychiatric condition requiring pharmacological treatment.
2. Use of anxiolytics, antidepressants, antipsychotics, or herbal supplementsfor stress/anxiety (e.g., ashwagandha, valerian root, L-theanine) within the past 4 weeks.
3. Current or recent history (within 6 months) of alcohol or substance abuse (e.g., cannabis, opioids, stimulants).
4. Known or suspected neurological, cardiovascular, renal, hepatic, or endocrine disorders that may interfere with the study or safety of the participant.
5. Pregnant or lactating women, or those planning pregnancy during the study.
6. Known hypersensitivity or allergy to any component of JOFP-001 capsule.
7. Uncontrolled hypertension, diabetes, or other chronic diseases that may affect study outcomes or participant safety.
8. Any condition (e.g., cognitive impairment, language barrier) that, in the investigator’s judgment, may affect the participant’s ability to provide informed consent or comply with study procedures.
9. Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day for men or 1 drink/day for women)
10. Participants participated in any investigational study medication within thirty (30) days prior to screening.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome

Outcome	TimePoints
Mean change from baseline in Perceived Stress Scale (PSS) score Depression, Anxiety, Stress Scale-21 (DASS-21)	Day -7, Day 0, Day 30, Day 45, Day 60

Secondary Outcome

Outcome	TimePoints
Mean change from baseline in DASS-21 Subscale Score Serum cortisol Levels Pittsburgh Sleep Quality Index (PSQI) Profile of Mood States (POMS)	Day -7, Day 0, Day 30, Day 45, Day 60

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

08/11/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="2"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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 study is designed to evaluate the efficacy and safety of JOFP-001 capsules in the management of stress and anxiety in healthy adult subjects. The main purpose of the trial is to determine whether JOFP-001 reduces perceived stress levels and improves anxiety scores compared to placebo. The study hypothesis is that JOFP-001 will show a significant reduction in stress and anxiety measures and will be well tolerated in healthy adults.