A Clinical study on swarasa bhavitha Aswattha patra choorna in Nidranasha (Primary insomnia)

Clinical study on swarasa bhavitha Aswattha patra choorna in Nidranasha(primary insomnia) - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074532

Enrollment

Registered

2024-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed case of primary insomnia Subjects who are ready to take part in the study with their consent.

Exclusion criteria

Exclusion criteria: Use of any substance with psychotropic effects or properties is known to affect sleep wake cycle. Subjects with secondary causes like breathing related sleep disorder, psychiatric related sleep disorder, sleepwalking disorder. Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder. Night shift workers and individuals who nap three or more times per week over the preceding month. Females who are lactating or who are pregnant.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the single-arm clinical trial to evaluate the effectiveness of Swarasa Bhavitha Aswattha patra Choorna in Nidranasha (Primary Insomnia) is the reduction in the Insomnia Severity Index (ISI) scores from baseline to the end of the treatment period. The goal is to determine whether there is a significant decrease in ISI scores, indicating an improvement in the severity of insomnia symptoms among the participants.Timepoint: Baseline- day 0 day 28 Follow up after 15 days (day 43)	—

Measure

Time frame

The primary outcome of the single-arm clinical trial to evaluate the effectiveness of Swarasa Bhavitha Aswattha patra Choorna in Nidranasha (Primary Insomnia) is the reduction in the Insomnia Severity Index (ISI) scores from baseline to the end of the treatment period. The goal is to determine whether there is a significant decrease in ISI scores, indicating an improvement in the severity of insomnia symptoms among the participants.Timepoint: Baseline- day 0 day 28 Follow up after 15 days (day 43)

—

Secondary

Measure	Time frame
No secondary outcomesTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr Tapas Brata Tripathy

Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hassan

drdixsaya@gmail.com7708808450

Outcome results