None listed
Conditions
Interventions
Intervention1: JOFP-001: JOFP-001 is a 300 mg standardized ashwagandha based capsule to be taken once daily after food at night for 60 days.
Control Intervention1: Placebo: Matching placebo 300 mg ca
contains inert excipients only. to be taken once daily after food at night for 60 days.
Sponsors
Jeeva Organic Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Perceived Stress Scale (PSS) score Depression, Anxiety, Stress Scale-21 (DASS-21) Timepoint: Day -7, Day 0, Day 30, Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in DASS-21 Subscale Score Serum cortisol Levels Pittsburgh Sleep Quality Index (PSQI) Profile of Mood States (POMS) Timepoint: Day -7, Day 0, Day 30, Day 45, Day 60 | — |
Countries
India
Contacts
Public ContactDr Janani Sankar
Chennai Meenakshi Multispeciality Hospital
Outcome results
None listed