Health Condition 1: G470- Insomnia
Conditions
Interventions
None listed
Sponsors
Dr Almas Yaser Khan
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients suffering from minimum 50 % of signs and symptoms of Nidranash and Insomnia Severity Index ranging from 8 to 21 from mild to moderate severity. 2) Patients suffering from both primary and secondary Insomnia irrespective of pre-existing systemic disease which is the causative factor for Insomnia.
Exclusion criteria
Exclusion criteria: 1)History or diagnosis of another sleep disorder like bipolar disorder, psychotic disorder post-traumatic stress disorder, current psychiatric disorder that requires advanced medication. 2)History of neurological disorder causing Insomnia. 3)History of substance abuse or dependence. 4)History or current evidence of a clinically significant cardiovascular disorder. 5)Patients taking medications falling under Schedule IV (Controlled Substances Act). (https://www.drugs.com/schedule-4-drugs.html) 6) Subject having night shift duty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Sore and Insomnia Severity Index score will be taken as the as the assessment parametersTimepoint: Pittsburgh Sleep Quality Index score and Insomnia Severity Index score will be assessed in questionnaire form at screening visit, baseline visit, on 15th day and on 30th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| The comparison of before & after improvement in Sleep latency in minutes & Sleep Efficiency in percentage will be considered as secondary outcomeTimepoint: Sleep latency in minutes & Sleep Efficiency in percentage will be assessed at Screening Visit, baseline visit, 15th day & 30th day | — |
Countries
India
Contacts
Public ContactDr Almas Yaser Khan
Dr. D. Y. Patil Vidyapeeth (Deemed to be University), Pune
Outcome results
None listed