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Effect of Shirolepa in Primary Insomnia

A Randomised Waitlist-Controlled Trial on the efficacy of Shirolepa in adults with Primary Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045226
Enrollment
38
Registered
2022-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

Interventions

None listed

Sponsors

Lochan Acharya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed with primary insomnia as per research diagnostic criteria for primary insomnia 2. The insomnia severity index (ISI) score is more than eight points but less than 21 points

Exclusion criteria

Exclusion criteria: 1. Indication of moderate/severe depressive or anxiety symptoms (score > 14 on the depression scale, score > 10 on the anxiety scale and score > 19 on the stress scale of DASS-21) 2.Undergoing treatment or had taken any treatment for insomnia in 3. Pregnant or lactating women 4.Nocturnal shift-work (i.e., working between 12:00 am and 6:00 am)

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index (ISI)Timepoint: Baseline (after participant enrollment) Endpoint (after 7 days of intervention)—

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI), Actigraphy wristwatch sleep parameters, Sleep diary, Epworth Sleepiness Scale (ESS)Timepoint: Baseline (after participant enrollment) Endpoint (after 7 days of intervention)—

Countries

India

Contacts

Public ContactRemya Vijayan

Government Ayurveda College, Tripunithura

seena@ayurvedacollege.ac.in9447190133

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026