Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Conditions
Interventions
Intervention1: VHAKM- Akkermansia muciniphila: Dose: Take one capsules or as
directed, best taken prior to a meal.
Frequency: One Capsule or as directed.
Route of Administration: Oral
Total Duratio
Sponsors
Vidya Herbs Pvt LTD
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 Years to 65 Years Both males and females Patients willing to provide written informed consent and comply with protocol requirements.
Exclusion criteria
Exclusion criteria: Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding, Known inflammatory bowel disease or celiac disease patients, Immunocompromised patients, Pregnancy or wishing to become pregnant during the study, End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency, The use of other probiotic products or antibiotics over the previous 6 months, Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the reaction time (in milliseconds) will be measured at from using a computerized task-switching color-word Stroop task following acute stress from baseline to Day 60, Self reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) in a non-stressful condition, Anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) total Pittsburgh Sleep Quality Index (PSQI) scores.Timepoint: Visit 01(Day 01) Baseline Screening and Enrollment Visit, Visit 04 Day 45 (Interim visit), Visit 05 (Day 60 ? 3 days) Final Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Accuracy (proportion correct; %false alarms) on a computerized taskswitching and an incongruent CWST, a go/no-go paradigm, a visual working memory maintenance paradigm, and a visual working memory complex span task (SYMSPAN) from baseline to Day 60 (end of study), Change in Self-reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) in a non-stressful condition from baseline to Day 60 (end of study), Change in Anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) total Pittsburgh Sleep Quality Index (PSQI) scores from baseline to Day 60 (end of study), Change in the Generalized Anxiety Disorder-7 (GAD-7) score from baseline to Day 60. (end of study)Timepoint: Visit 01(Day 01) Baseline Screening and Enrollment Visit, Visit 04 Day 45 (Interim visit), Visit 05 (Day 60 ? 3 days) Final Visit. | — |
Countries
India
Contacts
Public ContactDr Radha Parthasarathy
Srinivasan Rajalakshmi Memorial Hospital (SRMH)
Outcome results
None listed