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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

Not Applicable
Conditions
Health Condition 1: S060- Concussion
Registration Number
CTRI/2021/09/036480
Lead Sponsor
Dr P V Ramana
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To evaluate the effectiveness of Isha Kriya in enhancing Quality of Life Post mild Traumatic Brain Injury (mTBI) <br/ ><br>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 Outcome Measures
NameTimeMethod
1.To evaluate the effectiveness of Isha Kriya in reducing stress post mTBI. <br/ ><br>2.To evaluate the effectiveness of Isha Kriya in reducing depressionTimepoint: PSS and CES-D will be assessed at baseline and 06 weeks
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