Health Condition 1: null- Subjects with Sleep Irregularities
Conditions
Interventions
Intervention1: BlaQmax: Single 200mg capsule every day after the dinner for 30 days.
Control Intervention1: Nill: Nill
Sponsors
Akay Flavours and Aromatics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 25-65 Years ( Both Inclusive) 2) Male and Female Subjects 3) Patients suffering from any kind of sleep disorders including insomnia, nocturnal awakening etc. 4) Subject should be suffering from any kind of sleep irregularities for a minimum period of 1 month . 5) Subjects with a PSQI score Greater than 5. 6) Must agree to sign an Informed Consent Document.
Exclusion criteria
Exclusion criteria: 1) Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic and renal problems 2) Subjects who are currently under any kind of long term medication 3) Subjects with a known allergy to herbal products 4) Chronic drinkers 5) Subject with a habit of smoking 6) Subjects with abnormal biochemical or haematological values 7) Subjects with abnormal blood pressure 8) Pregnant or Lactating Women 9) Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from basline value in PSQI score Hamiltonâ??s Anxiety rating scale score. DASS 21 Score Sleep EEG Timepoint: Day 0, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Serum cortisol LevelTimepoint: Day0, Day 30 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Akay Flavours and Aromatics Private Limited
Outcome results
None listed