A Clinical trial to study the effect of SDLSNT21 tablet in Patients of Nidranash(Insomnia).

Phase 2

Not yet recruiting

• Conditions: Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,

• Registration Number: CTRI/2023/02/049355
• Lead Sponsor: Dean Faculty of Ayurved

Brief Summary

Insomnia is the disorder of initiation and/or maintenance of sleep where patient is having difficulty in initiating of sleep, difficulty in maintening sleep ( Frequent awakenings during the night, Early morning awakening.),Non restorative sleep where despite an adequate duration of sleep, there is sleep pattern as well as loss of quality and quantity of sleep.

Recent growth in digital media and smart phones has increased productivity expectations and blurred the line between work and personal life. All of these shortened free time, faster pace of life, and stress lead to sleep deprivation, which has serious implications for physical and mental health, job performance, and quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients having Classical Lakshana of Nidranash like Angamarda, Shirogaurava, Jrumbha, Jadyata, Glani, Bhrama, Apakti, Tandra.
• Diagnosed case of insomnia made according to the guidelines mentioned in DSM-V for 3 month and above.
• Patient ready to give inform consent and abide instruction.

Exclusion Criteria

• 1 Patient below 20 years & after 60 years.
• 2 Insomnia secondary to Major mental disorders.
• 3 Pregnant and Lactating women.
• 4 Patient with RTA, Alcoholism.
• 5 Patient with drug dependency like anti-histamines and narcotics.
• Patient with severe pain and orthopnea, Uncontrolled DM & HTN.
• Patient having chronic illness like IHD, COPD, Malignancies and other Medical conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment on the basis of gradation of classical symptomes of Nidranash.	At baseline,on 15th day and on 30th day.

Secondary Outcome Measures

Name	Time	Method
Assessment on the basis of Pittsburgh Sleep Quality Index .	At baseline,on 15th day and on 30th day.

Trial Locations

Locations (1)

Parul Ayurved Hospital; 🇮🇳 Vadodara, GUJARAT, India

Parul Ayurved Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Arpit Vankar

Principal investigator

9537539855

vankararpit666@gmail.com