Effect of Ayurvedic Intervention on cognition/memory in Type-2 diabetes mellitus patients
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/10/059169
- Lead Sponsor
- Pratiksha Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants of both the genders aged 40 to 65 years (upper limit to minimize differences in brain structural changes related to normal aging).
1. Participants who are not on any medication for cognitive health in the past 1 year.
2. Participants who have not taken any Ayurvedic intervention for DM.
3.BMI =30 (Obesity range).
4.Literate population (minimum 10th pass).
5.Participants (Type 2 DM) were on diabetes medication.
6.HbA1c levels should be more than 7 and less than 9.
7.Duration of Type 2 DM should be more than 2 Years.
8.Individuals should be able to cook a meal, shop, pay bills, etc., independently, even if they take longer or make errors scored using ADLQ.
9.Willing to sign the informed consent letter and participate in the study.
Inclusion Criteria for Healthy controls: -
1.Participants of both the genders aged 40 to 65 years (upper limit to minimize differences in brain structural changes related to normal aging).
2.Literate population (minimum 10th pass)
3.Controls will be non-diabetic and healthy, without any neurological issues that would introduce brain injury or drug dependency (e.g., tobacco, cocaine), that would modify brain hemodynamics and brain tissue, age-(±2 years) and gender-matched with Type 2 DM participants.
1.Recent ( <6 months) myocardial infarction, pregnancy (if subject is female), history of stroke, diagnosed psychiatric disease (clinical depression, schizophrenia, manic-depressive), airway or chest deformities that would interfere with breathing, mechanical ventilator support, and renal failure (requiring dialysis).
2.Patients who are on/ have taken (in past 2 years) Ayurveda medication.
3.Type 2 DM participants should not be on any medications which is known to impact neurological or cardiovascular functions.
4.BMI >30 (Obesity range).
5.Score of 5 and above on QDRS scale
6.Severe hearing or visual impairment which can alter cognitive test outcomes
7.Major psychological / psychiatric illness and on any anti-depressants, antipsychotic drug etc. for long term (more than 1 year)
8.Healthy controls having medical condition (i.e., Diabetes, Hypertension etc.)
•For FMRI participants: Claustrophobia, metallic-based tattoos, metallic implants or devices (e.g., implantable cardioverter-defibrillator [ICD], pacemaker, embolic coils, aneurysm clips), or any other material which could be hazardous in the fMRI scanner
9.Trauma: Head injury, in the past 1 year
10.Severe drug/alcohol addicts.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method