CTRI/2022/07/043943已完成不适用
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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Arterial stiffness will be measured using aortic pulse wave velocity
研究概览
简要总结
· To evaluate the safety and efficacy ofProprietary Therapy (Blessing/Biofield Energy Healing Therapy) by renownedreligious and spiritual leader Mahendra Trivedi in comparison with control andplacebo (sham healer) groups in improving physiological function,psychological, emotional, and mental health as well as wellness in adultvolunteers for a better quality of life.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •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.
排除标准
- •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.
- •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.
- •Volunteers who have used 9.
结局指标
主要结局
Arterial stiffness will be measured using aortic pulse wave velocity
时间窗: 12 weeks
The amount of AGE in tissue assessed using autofluorescence (AF) with the help of an AGE reader
时间窗: 12 weeks
Motor and cognitive functions will be evaluated using the NIH Toolbox motor test battery and NIH Toolbox cognitive test battery
时间窗: 12 weeks
Self-reported changes for symptoms/complaints will be assessed based on the Psychological Questionnaire Scoring (PQS) method mentioned in attachment III
时间窗: 12 weeks
Vitamins - 25 hydroxy cholecalciferol, 1, 25
时间窗: 12 weeks
次要结局
- Immune Biomarkers - Investigations related to immunity in blood:(Immunoglobulins: IgG, IgM, IgA)
研究者
研究点 (1)
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