| CTRI Number |
CTRI/2022/07/043943 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study for Improving Physiological Function, Psychological, Emotional and Mental Health as well as Wellness in Adult Subjects for a better Quality of Life. |
|
Scientific Title of Study
|
A Randomized, Placebo-Controlled, Double Blind, Three Arms, Parallel, Single-Center Study of the Safety and Efficacy of Blessing (Prayer)/Proprietary Therapy (Biofield Energy Healing Therapy) for Improving Physiological Function, Psychological, Emotional and Mental Health as well as Wellness in Adult Subjects for a better Quality of Life. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No.: C1B02089 Version: 01 Date:12 APR 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHAIFALI GUPTA |
| Designation |
M.D |
| Affiliation |
Cliantha Research Limited |
| Address |
TP-86, FP 28/1
Off SP Ring road Ahmedabad – 382210
Gujarat India
Ahmadabad
GUJARAT
382210
India |
| Phone |
9687603795 |
| Fax |
|
| Email |
sgupta@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAIFALI GUPTA |
| Designation |
M.D |
| Affiliation |
Cliantha Research Limited |
| Address |
TP-86, FP 28/1
Off SP Ring road Ahmedabad – 382210
Gujarat India
GUJARAT
382210
India |
| Phone |
9687603795 |
| Fax |
|
| Email |
sgupta@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAIFALI GUPTA |
| Designation |
M.D |
| Affiliation |
Cliantha Research Limited |
| Address |
TP-86, FP 28/1
Off SP Ring road Ahmedabad – 382210
Gujarat India
GUJARAT
382210
India |
| Phone |
9687603795 |
| Fax |
|
| Email |
sgupta@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Trivedi Global, Inc., 10624 S. Eastern Avenue Suite A-969 Henderson NV 89052. |
|
|
Primary Sponsor
|
| Name |
Trivedi Global Inc |
| Address |
10624 S. Eastern Avenue Suite A-969 Henderson NV 89052. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHAIFALI GUPTA |
Cliantha Research limited |
Garden View Corporate House No. 7,
Opp. Auda Garden, Bodakdev,
Ahmedabad – 380054 - India
Ahmadabad
GUJARAT |
91-79-68221100
sgupt@cliantha.com |
| DR SHAIFALI GUPTA |
Cliantha Research limited |
Sigma-I Corporates,
Near Mann Party Plot,
Off. Sindhu Bhawan Road, Bodakdev,
Ahmedabad – 380054 - India
Ahmadabad
GUJARAT |
91-79-66135601
sgupt@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Submittted/Under Review |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improving Physiological Function, Psychological, Emotional and Mental Health as well as Wellness in Adult Subjects for a better Quality of Life. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Test Arm 1 (Control) |
Day 0, day 90 |
| Intervention |
Test Arm 2 (Placebo) |
Day 0, day 90 |
| Intervention |
Test Arm 3 (DT Blessing Group) |
Day 0, day 90 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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 or independent of others
• How you perceive about yourself - in terms of beauty, intelligence, personality, magnetism, ability, etc.
• How you perceive about people in your environment - in terms of beauty, intelligence, behavior, cooperation, appreciation, influence on happiness, etc.
• How do people in your environment perceive about you - in terms of beauty, intelligence, behavior, cooperation, appreciation, etc.
Relationships & Social
• Trust in others
• Parent-children bonding
• Better associates and resourceful associates
• Mutual understanding, cooperation and caring in relationships
Sexual Health
• Impotence
• Displeasure in sex
• Low Sexual Stamina
• Premature ejaculation
• Low frequency of Sex
• Lack of Desire for sex / Low libido
Occupation/Finances
• Status of job
• Status of income
• Status of business
Menstrual Cycle
• PMS
• Nausea
• Cramps
• Bloating
• Back pain
• Irritability
• Hot flashes
• Muscle pain
• Night sweats
• Mind Chatter
• Mood Swings
• Breast tenderness
• Appetite problems
• Digestive problems
• Mental restlessness
• Emotional Instability
• Headaches / Migraines
• Constipation / Diarrhea
• Menstrual cycle disorder
• Heavy Bleeding / Spotting
• Exhaustion / Tiredness / Fatigue
4. BMI: 18.5 to 35.0 kg/m2, both inclusive. BMI is calculated as weight in kg/ (height in meters)2.
5. If a female is of childbearing potential and is willing to use an acceptable form of birth control during the study.
6. Is willing to provide written informed consent and able to follow the study directions to participate in the study and complete all follow-up visits.
7. Is able to comply with the study requirements and procedures as per protocol.
8. All volunteers must be judged for eligibility by the principal investigator or sub-investigator or physician and psychologist during a pre-study screening assessment.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The amount of AGE in tissue assessed using autofluorescence (AF) with the help of an AGE reader
Motor and cognitive functions will be evaluated using the NIH Toolbox motor test battery and NIH Toolbox cognitive test battery
Arterial stiffness will be measured using aortic pulse wave velocity
Self-reported changes for symptoms/complaints will be assessed based on the Psychological Questionnaire Scoring (PQS) method mentioned in attachment III
Vitamins - 25 hydroxy cholecalciferol, 1, 25
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2022 |
| Date of Study Completion (India) |
11/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
·
To evaluate the safety and efficacy of
Proprietary Therapy (Blessing/Biofield Energy Healing Therapy) by renowned
religious and spiritual leader Mahendra Trivedi in comparison with control and
placebo (sham healer) groups in improving physiological function,
psychological, emotional, and mental health as well as wellness in adult
volunteers for a better quality of life. |