None listed
Conditions
Interventions
Intervention1: Test Arm 1 (Control): Day 0, day 90
Intervention2: Test Arm 2 (Placebo): Day 0, day 90
Intervention3: Test Arm 3 (DT Blessing Group): Day 0, day 90
Control Intervention1: NA: NA
Sponsors
Trivedi Global Inc
Eligibility
Inclusion criteria
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 and Pleasure in Life • Happiness – is it dependent on others
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The amount of AGE in tissue assessed using autofluorescence (AF) with the help of an AGE reader 2. Motor and cognitive functions will be evaluated using the NIH Toolbox motor test battery and NIH Toolbox cognitive test battery 3. Arterial stiffness will be measured using aortic pulse wave velocity 4. Self-reported changes for symptoms/complaints will be assessed based on the Psychological Questionnaire Scoring (PQS) method mentioned in attachment III Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune Biomarkers - Investigations related to immunity in blood: Immunoglobulins: IgG, IgM, IgA Neurotransmitter levels - acetylcholine, adrenaline, noradrenaline, serotonin, dopamine Stress Biomarkers - Malondialdehyde (MDA), superoxide dismutase (SOD), catalase, GSH, GPX Antiaging Biomarker - Klotho protein Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDR SHAIFALI GUPTA
Cliantha Research Limited
Outcome results
None listed