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
|
|
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
|
|
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. |