Health Condition 1: F519- Sleep disorder not due to a substance or known physiological condition, unspecified
Conditions
Interventions
None listed
Sponsors
Sri Sri Institute for advanced research SSIAR
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.
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.Patient with psychiatric illness or concomitant disorder or any other condition that could potentially disturb or have impact on sleep. 3.Patients using tobacco products or caffeinated beverages during night awakenings. 4.Patients on any medication for insomnia. 5.Patients using any sedative hypnotic drugs including benzodiazepines, non-benzodiazepine synthetic drugs, herbal and OTC products. 6.Patients working in night shifts within 5 days of screening or intended to do so during the course of the study. 7.Patients with history of alcohol abuse or drugs abuse. 8.Patients who were using any other medication that are known to influence sleep but could not be withdrawn. 9.Patients who are participated in another investigational drug had been used within three months prior to screening in this study. 10.Patients who could not be relied upon to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Sleep duration and Sleep quality.Timepoint: Day0,Day15,Day30. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the sleep quality of individuals under Ayurveda medication.Timepoint: Day0,Day15,Day30. | — |
Countries
India
Contacts
Public ContactDr Yogeshwar Chippa
Sri Sri Institue of Advanced Research
Outcome results
None listed