None listed
Conditions
Interventions
Intervention1: De-Stress and Focus capsule- U001: Two capsules in sequence daily after meal for 60 days.
Intervention2: De-Stress and Focus capsule - I001: Two capsules in sequence daily after meal fo
Sponsors
Herbolab India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18-50 years both inclusive 2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3. Scoring 18-26 on the Montreal Cognitive Assessment MoCA 4. No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire FAQ 5. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 6. No severe anxiety and depression on GAD and PHQ-9 scales 7. Able to complete the cognitive assessment tests
Exclusion criteria
Exclusion criteria: 1.Inability to perform any of the assessments required for endpoint analysis 2.Shows signs of Dementia, such as caused by Alzheimer’s Disease, acquired immunodeficiency syndrome AIDS, Creutzfeldt-Jakob disease, Lewy Bodies dementia LBD, Cerebrovascular dementia CVD, Progressive Supranuclear Palsy PSP, multiple cerebral infarctions, or normal pressure hydrocephalus NPH, cardiac disease or endocrine disease 3.Have any other neurodegenerative diseases 4.History of a seizure disorder 5.Known hypersensitivity to investigational products 6.Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy 7.Sitting or resting systolic blood pressure more than 180 mm Hg or diastolic blood pressure more than 110 mm Hg at Screening. 8.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years 9.Participants currently using medications and or supplements that could have cognitive or mood effects including but not limited to nutraceutical, allopathic, ayurvedic herbal extract or supplement 10.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 11.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude the successful completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are as follows- 1.Changes in perceived stress scale (PSS) score, Montreal Cognitive Assessment (MoCA) scale score, Rey Complex Figure Test (RCFT), Trail Making Test (TMT) score, digit span memory test, fatigue severity scale (FSS) score, mental chatter 5-point scale, Epworth Sleepiness Scale for daytime sleepiness, energy levels by using energy audit diary. 2.Assessment of alertness, orientation, and executive control functioning and executive/arousal vigilance will be assessed using ANTI-Vea-UGR computerized test(5 participants from each group i.e, total 15 participants) 3. Assessment of changes in the adult ADHD Self-Report Scale (ASRS) score 4.COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression) 5.Serum cortisol levelsTimepoint: 1.Screening, baseline, day 15, day 30, day 60 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 3.Screening, baseline, day 15, day 30, day 60 4.Screening and day 60 5.screening, day 15 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are as follows- 1.Assessment of adverse events, treatment compliance and tolerability of investigational products, changes in vital sign parameters 2.Assessment of changes in complete blood count, liver function test and kidney function testTimepoint: 1.Baseline, day 15, day 30, day 60 2.Screening and day 60 | — |
Countries
India
Contacts
Public ContactDr Kriti Soni
Herbolab India Pvt. Ltd.
Outcome results
None listed