Health Condition 1: F30-F39- Mood [affective] disorders
Conditions
Interventions
Intervention1: Cognisol: Oral administration of Cognisol twice a day for 84 days
Control Intervention1: Placebo: Oral administration of Placebo twice a day for 84 days
Sponsors
Unique Biotech Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Overall healthy subjects, those experiencing moderate mental health concerns such as moderate depression and anxiety disorder along with significant sleep disturbances (such as sleeplessness, depressive episode, recurrent depression, mixed depressive and anxiety disorder) assessed by:i.Beck’s depression Inventory (BDI-II): 21-30 score ii.Hamilton Anxiety Rating Scale (HAM-A): 18-24 score iii.Pittsburgh sleep Quality Index (PSQI): Greather than 5 score. 2.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 3.Willing to give written informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Subject with history of i.Use of any anti-depressant drug ii.Use of any antibiotic drug in the past 4 weeks iii.Use of natural health products that affect depression and sleep iv.Use of any sleep medication in the past 4 weeks v.Daily use of probiotic product in the past 2 weeks vi.Use of any type of laxative 2.Subjects with history of psychiatric disorders, severely suicidal and experiencing psychosis or bipolar episode 3.Subjects with of alcohol or substance abuse in the past 6 months4.Subjects with history of epilepsy or uncontrolled seizures 5.Women who are pregnant, breast feeding or planning to become pregnant during the trial 6.Subjects with known Immunodeficiency 7.Subjects with unstable medical conditions or serious diseases/ conditions (e.g. cancer, cardiovascular. renal, lung, diabetes, psychiatric illness, bleeding disorders etc.) 8.Subjects with history of Electroconvulsive therapy (ECT) in the year prior to participation in the study. 9.Subjects taking antidepressant medication or other not-permitted treatment that cannot be safety discontinued. 10.A significant change in the treatment schema with proton-pump inhibitors, metformin, laxatives, systemic steroids, nonsteroidal anti-inflammatory drugs, antipsychotics, or any other medications influencing the microbiota according to present knowledge in the previous four weeks. 11.Subjects having hypersensitivity or history of allergy to any component of the study product.12.Unable to take medication orally or tolerate oral rehydration.13.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.14.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations or any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.15.Use of any other investigational drug currently or within 30 days prior to study entry. 16.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 17.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the following efficacy parameters assessed in the investigational product arm compared to placebo: Anxiety & Depression will be assessed through various questionnairesTimepoint: Baseline, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the efficacy parameters including biomarkers for stress, sleep, GI symptoms, inflammatory stress, depression, and alterations in gut microbiota.Timepoint: Baseline, Day 42, Day 84;Overall SafetyTimepoint: Baseline, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Servicces Pvt. Ltd.
Outcome results
None listed