Health Condition 1: Z733- Stress, not elsewhere classified
Conditions
Interventions
Intervention1: Treatment 1: One capsule orally twice daily after the meal for 60 days.
Intervention2: Treatment 2: One capsule orally twice daily after the meal for 60 days.
Intervention3: Treatment
Sponsors
Mane Kancor Ingredients Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study. 1. Male and female participants aged 21 to 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 that is 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 Alzheimers Disease Acquired Immuno Deficiency 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 110mm 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 15, day 30 and day 60. 2. Changes in serum cortisol levels at screening, day 30 and day 60. 3. Changes in Hamilton Anxiety Rating Scale (HAM-A) score at screening, day 30 and day 60. 4. Changes in COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score at screening, day 30 and day 60. 5. Changes in STAI (State-Trait Anxiety Inventory) score at screening, day 30 and day 60. 6. Changes in Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression) at screening, day 15, day 30 and day 60. 7. Changes in visual analogue scale score- for evaluation of fatigue, nausea, palpitation, breathlessness at screening, day 30 and day 60. 8. Changes in Modified Sleep Regularity and Medication Withdrawal Questionnaire (MSRMWQ)Timepoint: Screening, day 15, day 30 and day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety endpoints of our study include assessment of 1. Adverse events at baseline, day 15, day 30, and day 60. 2. Changes in hematological and biochemical parameters like complete blood count, liver function test and kidney function test at screening and day 60. 3. Assessment of treatment compliance and tolerability of investigational products at day 30 and day 60. 4. Changes in vital signs at screening, baseline, day 15, day 30, and day 60. Timepoint: Screening, baseline, day 15 , day 30 and day 60 | — |
Countries
India
Contacts
Public ContactDr Sherena PA
Mane Kancor Ingredients Pvt Ltd
Outcome results
None listed