None listed
Conditions
Interventions
Intervention1: Chamomile Valerian Herbal Tea: Subject will be instructed to drink Chamomile Valerian Herbal tea twice daily once in the evening between 5 to 7 PM, and once 30 to 60 minutes before slee
Sponsors
Luxmi Tea Co. Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females above the age of 18 years who experience anxiety and have difficulty initiating and or maintaining sleep. 2. Subject or the subject s legally authorized representative willing to give written informed consent. 3. Subjects willing to come for visits at the site as per protocol. 4. Non-Smoker. 5. Subject should not be on Antidepressant or any medication for anxiety. 6. Subject should not be on sleep medication. 7. Subject should not be consuming any dietary supplements consisting Chamomile or Valerian till the end of study.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women. 2. Subjects consuming sedative hypnotics, benzodiazepines, cyclopyrrolones, imidazopyridines, barbiturates, etc. 3. Severe psychiatric disorders. 4. Restless legs or leg cramps that influence sleep and everyday life. 5. Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc.). 6. Breathing problems (asthma, severe snoring, sleep apnea, etc). 7. Subjects with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy. 8. Irregular work hours, including shift work at night. 9. Subject consuming alcohol. 10. High caffeine intake (More than 10 cups per day) or equivalent caffeine intake from other caffeinated drinks example tea, energy drinks. 11. Contraindication or allergy to any substance in the investigational product. 12. Currently, or within the past 30 days, enrolled in a different clinical investigation. 13. Unable or unwilling to provide written informed consent for participation in the study. 14. Subjects suffering from chronic illness or any other condition that, in the opinion of the investigator, may compromise the safety and compliance of the participant or preclude the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Sleep: Total Sleep Time and the Number of Awakenings Post Sleep Onset using Sleep Diary , Evaluation of Quality of Sleep through Sleep Quality Scale (SQS) score, Evaluation of Anxiety: Hamilton Anxiety Rating Scale (HAM-A) score.Timepoint: Screening and Baseline (Day 0) and end of study (Day 46) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of Day Functionality through Stanford Sleepiness Scale (SSS) score 2. Evaluation of Quality of Life through World Health Organization-Five Well-Being Index (WHO-5) 3. Safety Lab Complete Blood Count (Haemoglobin, Haematocrit, RBC count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Platelet count, White blood cell count) 4. Treatment Emergent Adverse Event Timepoint: Screening and Baseline (Day 0) and end of study (Day 46) | — |
Countries
India
Contacts
Public ContactMrs Aditi Vaidya
ProRelix Services LLP
Outcome results
None listed