Health Condition 1: -
Conditions
Interventions
Intervention1: Withania somnifera (whole plant) extract 500 mg: One capsule, after dinner for 30days.
Control Intervention1: Placebo: One capsule, after dinner for 30days.
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female participant above 18 to 60 years of age and willing to give written inform Consent. 2. Perceived total sleep time of more than 6 hours per night 3. Patient with history of self-reported primary insomnia Or with diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV [DSM-IV-TR]
Exclusion criteria
Exclusion criteria: 1. Female who are pregnant, breast feeding or not willing to use adequate contraception during the course of the study. 2. BMI more than or equal to 18.5 or less than or equal to 35 kg/m2 3. Patient with psychiatric illness or concomitant disorder or any other condition that could potentially disturb or have impact on sleep. 4. Patients using tobacco products or caffeinated beverages during night awakenings. 5. Patient with diagnostic history of serious illness liver, kidney, heart, thyroid or bone marrow. 6. Patients on any medication for insomnia. 7. Patients with liver function parameters (total bilirubin, conjugated bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase) more than 2 times upper limit of normal. 8. Patients using any sedative hypnotic drugs including benzodiazepines, non-benzodiazepine synthetic drugs, herbal and OTC products. 9. Patients worked in night shifts within 5 days of screening or intended to do so during the course of the study. 10. Patients with history of alcohol abuse or drugs abuse. 11. Patients who were using any other medication that are known to influence sleep but could not be withdrawn. 12. Patients undergoing treatment for any other systemic illness. 13. Patients who are participated in another investigational drug had been used within three months prior to screening in this study. 14. Patients with known allergic reaction to the investigational product. 15. Patients who could not be relied upon to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in the Sleep Condition Indicator (SCI). 2. Mean change in total sleep timeTimepoint: 1. Day 0, Day 7 and Day 30. 2. Day 0, Day 7 and Day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in average sleep latency per night 2. Mean change in average no of night-time awakenings per night. 3.Mean change in the salivary cortisol 4. Mean change in the WHO quality of life Questionnaire 5. Safety of Ashwagandha (whole plant) extract through changes in complete blood count (CBC); blood biochemistry test profile and occurrence of adverse events through the study periodTimepoint: 1. Day 0, Day 7 and Day 30 2. Day 0, Day 7 and Day 30 3. Day 0 and Day 30 4. Day 0 & Day 30 5. Day 0 to Day 30 | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
Sami-Sabinsa Group limited
Outcome results
None listed