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A study to evaluate the efficacy of Aparajita Churna in Primary Insomnia.

A Randomized open labelled controlled clinical study to evaluate the efficacy of Aparajita Churna in the management of Primary Insomnia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052263
Enrollment
30
Registered
2023-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: G470- Insomnia

Interventions

None listed

Sponsors

Dr. Stebin Anto
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects between age group of 21-60 years of either gender. Subjects fulfilling the diagnostic criteria of Primary Insomnia according to DSM 5. Mild and moderate cases as per Insomnia severity index (score between 8-21) Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand

Exclusion criteria

Exclusion criteria: Subjects on sleep inducing medications. Subjects on drugs known to cause drowsiness. Subjects on psychiatric treatments. Subjects with insomnia secondary to pre-existing conditions like Schizophrenia, mood disorders, BPAD, etc. Pregnant and Lactating women. Any other condition interfering the course of the disease and the intervention.

Design outcomes

Primary

MeasureTime frame
Changes in Insomnia Severity IndexTimepoint: before intervention- 0th day during intervention- 15th day after intervention- 30th day follow up- 45th day—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Neelakanta J Sajjanar

Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore

neelkant.ayu@gmail.com8147891325

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026