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A Clinical Study to evaluate effectiveness of Isha Kriya in enhancing Quality of Life and reducing fatigue symptoms in patients who sustained mild traumatic brain injury

A Prospective Comparative pilot study to evaluate the effectiveness of Isha Kriya in enhancing quality of life and improving fatigue symptoms post mild traumatic brain injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036480
Enrollment
56
Registered
2021-09-14
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: S060- Concussion

Interventions

Intervention1: Isha Kriya and Standard of Care: Isha Kriya is a simple meditation practice offered by Isha foundation which will take 12 minutes to complete, this regimen was chosen because of its sim

Sponsors

Dr P V Ramana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female aged between 18- 60 years (both inclusive). 2. Individuals with Glasgow Coma Scale indicating mild TBI i.e GCS score of 13-15. 3. History of injury within past 3 months to 1 years 4. Individuals with the ability to understand and provide written informed consent form, which must have been obtained before the screening. 5. Individuals willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Individuals who are on psychiatric medication. 2. Individuals with injuries other than head injury, which may be hindrance for meditation. 3. Individuals who attended any type of yoga classes in the past six months and practicing regularly. 4. Individuals with any type of persistent neurological disorders. 5. Individuals with a history of drug or alcohol abuse. 6. Individuals with below high school education or equivalent. 7. Suspected inability or unwillingness to comply with the study procedures.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the effectiveness of Isha Kriya in enhancing Quality of Life Post mild Traumatic Brain Injury (mTBI) 2.To evaluate the effectiveness of Isha Kriya in improving fatigue symptoms post mTBITimepoint: QoLIBRI and FSS will be assessed at baseline and 06 weeks

Secondary

MeasureTime frame
1.To evaluate the effectiveness of Isha Kriya in reducing stress post mTBI. 2.To evaluate the effectiveness of Isha Kriya in reducing depressionTimepoint: PSS and CES-D will be assessed at baseline and 06 weeks

Countries

India

Contacts

Public ContactDr K Vittalnadh Pradeep

Pinnacle institute of Neurosceinces

neuroramana@gmail.com9908036235

Outcome results

None listed

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