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CTRI Number  CTRI/2018/09/015689 [Registered on: 11/09/2018] Trial Registered Prospectively
Last Modified On: 11/09/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Randomized controlled clinical trial 
Study Design  Randomized, Crossover Trial 
Public Title of Study   INVESTIGATION OF THE EFFECT OF GUT BACTERIA ON MARKERS OF INFLAMMATION IN PATIENTS OF HIGH CHOLESTEROL WHO TAKING STATIN DRUGS AS TREATMENT 
Scientific Title of Study   TO INVESTIGATE THE INFLUENCE OF GUT MICROBIOTA COMPOSITION ON INFLAMMATORY MARKERS IN HYPERCHOLESTEROLEMIC SUBJECTS ON STATIN THERAPY 
Trial Acronym  MIST 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Jain  
Designation  Sr. Demonstrator/Tutor, Department of Biochemistry RUHS-CMS, Jaipur 
Affiliation  RUHS College of Medical Sciences, Jaipur 
Address  Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur, Rajasthan
Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur, Rajasthan 302033
Jaipur
RAJASTHAN
302033
India 
Phone  9460782342  
Fax    
Email  priyanka_24feb@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Sharma  
Designation  Professor &Head, Department of Biochemistry RUHS-CMS, Jaipur 
Affiliation  RUHS College of Medical Sciences, Jaipur 
Address  Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur, Rajasthan
Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur, Rajasthan 302033
Jaipur
RAJASTHAN
302033
India 
Phone  9414314678  
Fax    
Email  sonalisharma14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Jain  
Designation  Sr. Demonstrator/Tutor, Department of Biochemistry RUHS-CMS, Jaipur 
Affiliation  RUHS College of Medical Sciences, Jaipur 
Address  Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur
Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur
Jaipur
RAJASTHAN
302033
India 
Phone  9460782342  
Fax    
Email  priyanka_24feb@ymail.com  
 
Source of Monetary or Material Support  
Department of Biochemistry, RUHS College of Medical Sciences and associated RDBP Jaipuria Hospital, Jaipur. 
 
Primary Sponsor  
Name  ARDU RUHS College of Health Sciences Jaipur 
Address  Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur, Rajasthan  
Type of Sponsor  Government medical college 
 
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 Priyanka Jain  Department of Biochemistry RUHS College of Medical Sciences, Jaipur  Near Shani Mandir, Kumbha Marg, Pratap Nagar, Sanganer, Sector 11, Jaipur
Jaipur
RAJASTHAN 
9460782342

priyanka_24feb@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS-CMS Ethics Committee, Rajasthan University of Health Sciences, Jaipur, Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Statin drug therapy  Statin will be administered orally at bedtime and dose of statin will be as follows: Group 1: Patients of Hypercholesterolemia receiving Moderate Dose (10 mg Atorvastatin) Statin Therapy Group 2: Patients of Hypercholesterolemia receiving High Dose (40 mg Atorvastatin) Statin Therapy Total duration of Statin therapy will be 12 weeks. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1.Confirmed cases of Hypercholesterolemia, defined as having the following: LDL >130 mg/dl, total cholesterol >200 mg/dl, HDL < 40 mg/dl according to National Cholesterol Education Program (NCEP) (Adult Panel Treatment III) guidelines for male subjec2. Presently not on Statin Therapy
 
 
ExclusionCriteria 
Details  1. Use of lipid-lowering drugs
2. Patients of Acute and Chronic infections
3. Overt Nephropathy
4. Use of antibiotics, antifungals, antivirals and antiparasitics drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To examine association between gut microbiome and inflammation at different doses of statin.  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of high and low dose of statin on inflammatory markers.
 
12 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hypercholesterolemia is an emerging health problem due to sedentary lifestyle. Mainly LDL cholesterol levels are increase in hypercholesterolemia that is a strong risk factor for cardiovascular disease. The statins or HMG-CoA reductase inhibitors are effective reduce LDL cholesterol levels as well as levels of inflammatory markers such as CRP, IL-6 and TNF-a. The human gastrointestinal system is populated with a variety of symbiotic organism namely, gut microbiota. Gut microbiota cause inflammation that increases CVD risks.

In this study, we are using statin therapy as a treatment to reduce inflammation and to find out effect of statin therapy on gut microbiota.

We will observe the association between gut microbiome and inflammation at different doses of statin. Secondly we will compare the effect of high and low dose of statin on inflammatory markers.


 
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