An observational study for Improving Physiological Function, Psychological, Emotional and Mental Health

Not Applicable

• Registration Number: CTRI/2022/07/043633
• Lead Sponsor: Trivedi Global Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 August 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Males or females between 20 to 55 years of age (both inclusive) at the time of consent.

2.Volunteers with a skin reflection of >6% measured via an AGE reader during screening.

3.Volunteers with at least one sign and symptom/complaint in at least five or more questions in attachment I and II (for screening) and five of the twelve categories mentioned in the psychological questionnaire in attachment III (for enrollment of the subjects in the study) which broadly include the following:

Physical Health

Fatigue

Tiredness

Joint pain

Back pain

Exhaustion

Low energy

Muscle pain

Constipation

Poor Digestion

Aches and pain

Chronic fatigue

General weakness

Appetite problems

Poor quality of skin

Laziness and lethargy

Poor quality and growth of hair

Poor quality and growth of nails

Sleep

Insomnia

Grogginess

Sleep Apnea

Disorientation

Heavy Headed

Sleep disturbances

Poor quality of Sleep

Not feeling refreshed on waking up in the morning

Stress

Tension

Anxiety

Sadness

Bad luck

Irritability

Depression

Panic attacks

Hopelessness

Loss of income

Constant worry

Poor concentration

Fear of the Unknown

Cognition and Memory

Mental fog

Confusion

ADD / ADHD

Indecisiveness

Difficulty Learning

Delusional thinking

Poor Memory (short/long term)

Inability to Focus / Concentration

Lack of Mental Peace / Calmness

Mental Restlessness / Mind Chatter

Poor Status of Alertness and Awareness

Lack of Judgment and Decision-making ability

Mental Health

PTSD

Worry

Anxiety

Addiction

Depression

Indiscipline

Mood swings

Stress / Tension

Fear of the Future

Emotional Trauma

Panic / Panic Attacks

Obsessive Compulsive Disorder

Feeling Lost & Lack of Direction

Emotional Health

•Sadness

•Uncertainty

•Stubbornness

•Hopelessness

•Shamelessness

•Low Willpower

•Guilt and Grief

•Boring / Boredom

•Lack of Confidence

•Suicidal Tendencies

•Poor Self-Awareness

•Dissatisfaction in Life

•Delusion / Impracticability

•Inability to sacrifice & be caring

•Pessimism & Negative Thoughts

•Numbness / Emptiness / Loneliness

•Anger / Hate / Hostility / Frustration

•Lack of Common-Sense and Judgment

•Lack of Empathy / Sympathy / Compassion

•Lack of Inspiration / Motivation / Enthusiasm / Ambition

•Lack of Appreciation / Low Self-worth / Low Self-esteem

•Apathy (Indifference / Lack of Interest, Feeling, Emotion)

Psychological Health

•Confusion

•Fearfulness

•Feeling Lost

•Feeling down

•Procrastination

•Problem denial

•Erratic behavior

•Purposelessness

•Lack of freedom

•Agitation/Aggression

Perception

•Feeling of Empowerment

•Feeling of Satisfaction

Exclusion Criteria

1.History within the last year or current problems with alcohol dependence or drug abuse.

2.Significant diseases or clinically significant abnormal findings in medical history, physical examination, laboratory evaluations, etc., during screening.

3.self-tanning agents within 10 days prior to screening. Regular vigorous aerobic/endurance exercise ( >3 vigorous bouts/week).

Note: Subjects performing exercise (except vigorous aerobic/endurance exercise >3 vigorous bouts/week) can be enrolled in the study if they agree to perform the same during the entire study period.

4.Volunteers receiving treatment for any of the complaints mentioned in inclusion criteria no. 3.

5.Known history of positive HIV, HCV, HBsAg or VDRL/RPR results.

6.Volunteers with non-healthy, non-homogenous or damaged skin over the measuring area used during the AGE reading.

7.Volunteers with birthmarks or excessive hair over the skin of the measuring area used during the AGE reading that can influence the results.

8. Volunteers who have used

9. Female volunteers with a positive pregnancy test, or who are currently breast-feeding or planning for pregnancy.

10.Any other acute or chronic illness that could compromise the integrity of the study data or place the subject at risk by participating in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The amount of AGE in tissue assessed using autofluorescence (AF) with the help of an AGE reader <br/ ><br>2. Motor and cognitive functions will be evaluated using the NIH Toolbox motor test battery and NIH Toolbox cognitive test battery <br/ ><br>3. Arterial stiffness will be measured using aortic pulse wave velocity <br/ ><br>4. Self-reported changes for symptoms/complaints will be assessed based on the Psychological Questionnaire Scoring (PQS) method mentioned in attachment III <br/ ><br>Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Immune Biomarkers - Investigations related to immunity in blood: <br/ ><br>Immunoglobulins: IgG, IgM, IgA <br/ ><br>Neurotransmitter levels - acetylcholine, adrenaline, noradrenaline, serotonin, dopamine <br/ ><br>Stress Biomarkers - Malondialdehyde (MDA), superoxide dismutase (SOD), catalase, GSH, GPX <br/ ><br>Antiaging Biomarker - Klotho protein <br/ ><br>Timepoint: 24 weeks