A comparative study where patients suffering from Nidranash (Insomnia) will be given either ayurvedic formulation (Swapa Vati) in tablet form or Tablet Melatonin an allopathic formulation for treating Nidranash (Insomnia).
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2024/07/070998
- Lead Sponsor
- Dr Almas Yaser Khan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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