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Behavioural Intervention
Advanced Meditation (Samyama) for Mental Health Wellness
N/A
Waitlist Available
Led By Senthilkumar Sadhasivam, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will investigate the effects of the Samyama program on neurotransmitters and the mind/psyche.
Who is the study for?
This trial is for adults over 18 who are advanced meditation program participants or their live-in spouses/significant others. It's not for those who can't understand the consent form, have conditions making blood draws unsafe, live outside the country, recently used certain supplements or antibiotics, or use marijuana/opioids.Check my eligibility
What is being tested?
The study examines how an advanced meditation technique called Samyama affects neurotransmitters and mental states. Participants undergo a preparatory phase with diet and yoga before testing through surveys and sample collection to see if there's less gut inflammation and improved wellbeing.See study design
What are the potential side effects?
Since this trial involves meditation practices rather than medication, traditional side effects are not expected. However, changes in consciousness levels during deep meditation could potentially cause unusual sensations or emotional responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epigenetic analysis (DNA methylation)
Levels of Brain Derived Neurotrophic Factor (BDNF)
Transcriptome analysis
+1 moreSecondary outcome measures
Gut Inflammation analysis
Microbiome analysis
Plasma
Other outcome measures
EEG
fMRI
Trial Design
4Treatment groups
Experimental Treatment
Group I: Timepoint 4: 3 months Post SamyamaExperimental Treatment2 Interventions
Blood draw at home by at home phlebotomist
Post program online survey follow up to be completed
Survey link for participant
Survey link for spouse: https
Stool collection from home
Group II: Timepoint 3: Immediate Post-SamyamaExperimental Treatment3 Interventions
Online survey to be completed
Survey link for participant
Survey link for spouse
Blood sample collection: on site at IIIS o Participant only - Not spouse/significant other. EEG and fMRI
Group III: Time point 2: Post-Preparatory/Pre-SamyamaExperimental Treatment3 Interventions
Online Surveys
Participant
Spouse
Stool collection from IIIS/home
Blood sample collection: on site at IIIS/home EEG and fMRI
Group IV: Time Point 1: Baseline/Pre-preparatory SamyamaExperimental Treatment2 Interventions
Survey link for participant
Survey link for spouse/ "control"
Stool collection from home
Blood sample at home provided by at home phlebotomy services or at Isha Center group meditation by study personnel.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,402 Total Patients Enrolled
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,341,582 Total Patients Enrolled
Senthilkumar Sadhasivam, MDPrincipal InvestigatorIndiana University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken antibiotics in the last 60 days.I haven't taken probiotic or prebiotic supplements in the last 60 days.I am 18 or older and participate in an advanced meditation program.I do not practice meditation.You are currently using marijuana, opioids, or related drugs.I am 18 or older and participate in an advanced meditation program.I live with someone who is part of the meditation program.
Research Study Groups:
This trial has the following groups:- Group 1: Timepoint 4: 3 months Post Samyama
- Group 2: Time Point 1: Baseline/Pre-preparatory Samyama
- Group 3: Time point 2: Post-Preparatory/Pre-Samyama
- Group 4: Timepoint 3: Immediate Post-Samyama
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still positions available for participants in this clinical trial?
"As per the clinicaltrials.gov database, this medical experiment is not presently taking on new participants - its initial posting was January 19th 2018 and it's latest update happened November 16th 2022. However, there are 1476 other studies that are actively searching for enrollees at present."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Indiana University
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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