Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified Health Condition 2: F39- Unspecified mood [affective] disorder
Conditions
Interventions
Intervention1: UO SAF 02: UO SAF 02 is a saffron extract.
one capsule 15mg
Twice daily for 8 weeks
Control Intervention1: Placebo: Placebo is an inert medication with no API
one capsule, Twice daily f
Sponsors
Xtractiva Life Science Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18–65 years of age 2. Adult males and females reporting having a low mood but: a) not diagnosed with a mood disorder such as depression, and b) assessed as not suffering from depression with Beck Depression Inventory score between 10-20 3. Otherwise healthy; including BMI 4. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy 5. Results of screening are within normal range or considered not clinically significant by the Principal Investigator 6. Willing to sign the informed consent and comply with study procedure
Exclusion criteria
Exclusion criteria: 1. Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion 2. Known hypersensitivity to herbal drugs/nutritional supplement/ foods 3. Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy 4. Diagnosed with hypertension and receiving/ prescribed antihypertensive medications 5. Diagnosed severe renal and/or hepatic insufficiency 6. Current or history of chronic alcohol and/or drug abuse 7. Participation in any other clinical trial during last 30 days 8. Simultaneous participation in another clinical trial 9. Since saffron may affect mood, people with any diagnosed mood disorders (major depressive disorder (MDD), bipolar disorders, substance-induced disorders) will be excluded. 10. Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep 11. Women who are suffering severe premenstrual pain (reason being that their mood, pain etc may change during the study period). 12. People suffering any neurological disorders such as multiple sclerosis. 13. People that can not exclude foods containing saffron or the use of saffron in their cooking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from baseline in Profile of Mood States (POMS) Timepoint: Day -7, day 28 & day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Positive & Negative Affect Schedule, (PANAS) Depression Anxiety Stress States (DASS-21) Pittsburgh Sleep Quality Index (PSQI) Blood Cortisol Timepoint: Day -7, day 28 & day 56 | — |
Countries
India
Contacts
Public ContactP Sudha Rani
Chennai Meenakshi Multispeciality Hospital
Outcome results
None listed