An Observational study to assess sleep quality and cognitive performance in different Deha Prakriti and a clinical trial to evaluate the effect of Bilva Khala on loss of sleep (Anidra)

An observational study on Nidra (sleep quality) and cognitive performance in different Deha prakriti and effect of Bilva Khala on Anidra (Primary insomnia) - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056999

Enrollment

Registered

2023-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Eligibility

Inclusion criteria

Inclusion criteria: Primary Insomnia like Insomnia without Identifiable Cause and Psycho-physiologic Insomnia having score more than 6. Fresh patients of Insomnia who are not addicted to drugs will be included. Insomnia cases not less than one month will be included.

Exclusion criteria

Exclusion criteria: Patients suffering from chronic Insomnia who were addicted to sedative medications and taking any drugs possessing sedative effect will be excluded. Secondary Insomnia like Transient Situational Insomnia, Insomnia Associated with Neurological Disorders, Mental Disorders, Drug or Alcohol-Dependent Insomnia Known case of chronic illness and other hormonal diseases Recently done surgery Pregnant ladies and lactating mother.

Design outcomes

Primary

Measure	Time frame
Improvement in condition will be assessed on the basis of changes in scoring patterns of Insomnia severity index & Athens insomnia scale on 0th & 42nd day. ?Changes in the clinical symptoms of Anidra 0th & 42nd day.Timepoint: 6 weeks	—

Secondary

Measure	Time frame
? Improvement in cognitive performance & stress & anxiety level by assessing the changes noted in scoring pattern of concerned scale 0th and 42nd day.Timepoint: 6 weeks	—

Countries

India

Contacts

Public ContactDr Swati Khandale

Institute of Teaching and Research in Ayurveda Jamnagar

khandale_swati@yahoo.com9850483223

Outcome results