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CTRI Number  CTRI/2019/03/018178 [Registered on: 19/03/2019] Trial Registered Prospectively
Last Modified On: 12/07/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Probiotics and stress  
Scientific Title of Study   A RANDOMIZED, DOUBLE BLIND STUDY OF PROBIOTICS ON PHARMACY STUDENTS WITH EXAMINATION STRESS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinay HR 
Designation  Assistant Professor Department Of Psychiatry 
Affiliation  Adichunchanagiri Institute Of Medical Sciences 
Address  Department Of Psychiatry Room No 18 Ground Floor Adichunchanagiri Hospital And Research Center BG Nagara Mandya

Mandya
KARNATAKA
571448
India 
Phone  8904093422  
Fax    
Email  drvinayhr@bgsaims.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Venkataraman 
Designation  Professor & Head 
Affiliation  SAC College of pharmacy 
Address  Department Of Pharmacy Practice Room No 35 Ground Floor SAC College of Pharmacy Adichunchanagiri University BG Nagara Mandya

Mandya
KARNATAKA
571448
India 
Phone  9980038331  
Fax    
Email  rajeshvenky_research@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Venkataraman 
Designation  Professor & Head 
Affiliation  SAC College of pharmacy 
Address  Department Of Pharmacy Practice Room No 35 Ground Floor SAC College of Pharmacy Adichunchanagiri University BG Nagara Mandya

Mandya
KARNATAKA
571448
India 
Phone  9980038331  
Fax    
Email  rajeshvenky_research@hotmail.com  
 
Source of Monetary or Material Support  
Unique Biotech Limited Plot No. 2, Phase-II, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy Dist Hyderabad-500 078 India.  
 
Primary Sponsor  
Name  Unique Biotech Limited 
Address  Unique Biotech Limited Plot No. 2, Phase-II, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy Dist Hyderabad-500 078 India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinay H R  Adichunchanagiri Hospital And Research Center  Adichunchanagiri Hospital And Research Center Department of Psychiatry Room No: 18 Ground Floor BG Nagara Mandya Dist Karnataka 571448
Mandya
KARNATAKA 		 8904093422

drvinayhr@bgsaims.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe,Adichunchanagiri Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Examination stress 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo capsules   Capsule with only excipients 1Capsule two times a day for 28 days  
Intervention  Probiotic capsules with glutamine   Each Capsule contains Proprietary probiotic blend of 10 billion cfu containing : Bacillus coagulans Unique IS2 Lactobacillus rhamnosus UBLR-58 Bifidobacterium breve UBBBr-01 Bifidobacterium lactis UBBLa -70 Bifidobacterium infantis UBBI-01 Lactobacillus plantarum UBLP- 40 and L. glutamine - 250 mg 1 Capsule two times a day for 28 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1. Young adults with no reported cardiac, renal or hepatic conditions.
2. Adults having no allergies or intolerance to lactose or gluten.
3. Adults with no prescribed medication or drug use.
4. Adults who are reported to consume no more than 3-5 alcohol units per week.
5. Female students were not taking hormonal contraceptives.
6. Subjects who are not allergic to milk or milk products.

 
 
ExclusionCriteria 
Details  1. Those who are already with adjuvant therapy like multivitamins.
2. Subjects who are not willing to participate or enrol.
3. Participation in any clinical study within the last 6 months.
4. Subjects who had probiotics 3 weeks before the inclusion.
5 Subjects with daily alcohol consumption > 30 gm.
6. Subjects with unstable physical illness and are bedridden.
7. Subjects meeting criteria for psychiatric disorders other than stress.
8. Subjects with co-morbidities or infection.
9. Subjects with current or recent antibiotic use.
10. Subjects with evidence of immunodeficiency, bleeding disorder or coagulopathy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the effect of probiotics in the treatment of stress using questionnaires- State - Trait Anxiety Inventory [STAI], Perceived Stress Scale [PSS], Depression Anxiety Stress Scale [DASS]  Visit 1- Treatment day ( Day 1)
Visit 2- ( Day 29±2 )

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To measure the serum cortisol level in stress before and after the treatment  Visit 1- Treatment day(Day 1)
Visit 2- ( Day 29±2)
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/04/2019 
Date of Study Completion (India) 16/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is to evaluate the role of probiotics in the management of stress. Stress in biological terms refers to the reaction of the body to the distrubance of eqililbrium given particular stimuli. Stress also changes behavior. It has been hypothesized that exposure to stress and negative life event is related to poor health outcome. Beyond the certain point, stress can also trigger the onset of serious mental health problem. Higher levels of cortisol indicate greater psychological stress.

Studies on probiotics in the management of health professional with stress due to examination shall be a boon among educational research in India and one of a kind in mental health promotion.
 
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