Health Condition 1: F51- Sleep disorders not due to a substance or known physiological condition
Conditions
Interventions
Intervention1: PistamelTM: administered orally in capsule form daily after dinner, with each capsule containing 100 mg for 28 days
Control Intervention1: Placebo (Cyclodextrin): identical in appearanc
Sponsors
Botanic Healthcare Pvt. Ltd
Botanic Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female adults aged 18 54 years 2.Willing to provide written informed consent 3.Free from psychiatric conditions (except mild stress) 4.Able to read and write in English
Exclusion criteria
Exclusion criteria: 1.Chronic alcoholics ( greater than 2 standard drinks per day) 2.Known cardiovascular disease, hypertension, liver or kidney disease 3.History of epilepsy, psychiatric conditions, or other significant medical conditions 4.Pregnant, lactating, or attempting to conceive 5.Currently participating in another clinical trial or received investigational product within 90 days 6.Taking medications other than oral contraceptives or hepatotoxic drugs (e.g., antitubercular, antiviral, paracetamol) 7.Acute narrow-angle glaucoma, prostate hypertrophy, or other chronic diseases affecting stress, sleep, or daily functioning 8.Diagnosable mental health disorder in the past 6 months or current use of psychotropic or herbal medication
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Serum Cortisol levels (a marker for stress and calmness)Timepoint: Day 1,Day 28;2.Changes in hs-CRP levels (a marker associated with sleep and stress)Timepoint: Day 1,Day 28;3.Improvement in QOL using the SF-36 questionnaire,Timepoint: Day 1,Day 28;4.Changes in Subject Global Assessment(SGA) and Physician Global Assessment (PGA) scoresTimepoint: Day 14, Day 28;5.Change in weight and BMI throughout the study durationTimepoint: Screening, Day 1, Day 14, Day 28;6.Assessment of the safety of PistamelTM through haematological and biological evaluations, including ECG, CBC, LFT, RFT, and RBSTimepoint: Day 1, Day 28 | — |
Primary
| Measure | Time frame |
|---|---|
| 1.Objective sleep measures: Daily sleep diary Monitoring (Consensus Sleep Diary) recorded at baseline (one week prior to intervention) and throughout the period of intervention (Day 1-28) i. Bedtime and wake-up time ii. Sleep onset latency (estimated time to fall asleep) iii. Number and duration of awakenings after sleep onset iv. Total sleep duration 2) Improvement in sleep quality as measured by the AIS score, from baseline to the end of the studyTimepoint: Screening, Day 1, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr HN Shivaprasad
Botanic Healthcare Pvt. Ltd
Outcome results
None listed