Health Condition 1: Z733- Stress, not elsewhere classified
Conditions
Interventions
Intervention1: Mentacalm Tablet: one Mentacalm tablet two times in a day after food orally.
Control Intervention1: NIL: NIL
Sponsors
Vedistry Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants aged 21-50 years (both inclusive); 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26; 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form; 4.No severe anxiety and depression i.e, Generalized anxiety disorder (GAD) score less than or equal to 10 and Patients’ health questionnaire-9 (PHQ-9) score less than or equal to 14; 5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period; 6.No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial); 7.Willing to limit caffeine consumption while in the study.
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 (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH); 3.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management; 4.Have any other neurodegenerative diseases or 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.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 8.Sitting or resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening; 9.Participants with a history of substance abuse, drugs, heavy use of alcohol, and or smoking within last 5 years; 10.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy endpoints of the study include assessment of: 1.Changes in Perceived stress scale (PSS) score at screening, day 30 and day 60. 2.Changes in Serum cortisol levels at screening, day 30 and day 60. 3.Changes in Depression anxiety stress scale (DASS) at screening, day 30 and day 60. 4.Changes in Hamilton anxiety rating scale (HAM-A) score at screening, day 30 and day 60. 5.Changes in Penn state worry questionnaire (PSWQ) score at screening, day 30 and day 60. 6.Changes in Profile of mood state (POMS) questionnaire score at screening, day 30 and day 60. 7.Changes in World health organization quality of life questionnaire (WHOQOL-BREF) score at screening, day 30 and day 60. 8.Changes in Modified Sleep Regularity and Medication Withdrawal Questionnaire (MSRMWQ) score after stopping treatment for 1 week (day 68). Timepoint: screening, day 30, day 60 and day 68 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of adverse events from baseline to end of the study. 2.Assessment of treatment compliance and tolerability of investigational products throughout the study. 3.Assessment of changes in vital sign parameters throughout the study. 4.Assessment of changes in physical examination such as weight, blood pressure and pulse at screening and end of the study. 5.Assessment of changes in complete blood count, liver function test and renal function test at screening and end of the study. Timepoint: screening, day 30 and day 60. | — |
Countries
India
Contacts
Public ContactDr Sandip Mali
Charak Pharma Pvt. Ltd
Outcome results
None listed