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CTRI Number  CTRI/2022/06/043558 [Registered on: 28/06/2022] Trial Registered Prospectively
Last Modified On: 31/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial to evaluate the efficacy and safety of investigational product (MXP22) on liver health. 
Scientific Title of Study   A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SY/211203/MASP/NFLD version 1.0 Date 31 - March 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Srivastava 
Designation  Associate Director - Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai

Mumbai (Suburban)
MAHARASHTRA
400053
India 
Phone  02242172300  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Srivastava 
Designation  Associate Director - Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai


MAHARASHTRA
400053
India 
Phone  02242172300  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashank Jadhav 
Designation  Medical Representator 
Affiliation  Synergia Life Sciences Pvt. Ltd. 
Address  Synergia Life Sciences Pvt. Ltd. 6/312, Jogani Industrial Complex, V N Purav Marg, Chunabhatti, Mumbai

Mumbai
MAHARASHTRA
400 022
India 
Phone  9930241802  
Fax    
Email  SSAJ@novozymes.com  
 
Source of Monetary or Material Support
Modification(s)  
Vedic Lifesciences Pvt Ltd 118, Morya House, Opp. Infinity mall, Andheri (West), Mumbai 400053 
 
Primary Sponsor  
Name  Synergia Life Sciences Pvt Ltd 
Address  6/312, Jogani Industrial Complex, V N Purav Marg, Chunabhatti, Mumbai 400 022 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudhir Maharshi  Dr Sudhir Maharshi Gastro Clinic  Dr Sudhir Maharshi Gastro Clinic 407, 4th Floor Akshat Retreat, Ramsingh Rd, opp. SMS Hospital, Jaipur, Rajasthan 302001
Jaipur
RAJASTHAN 		 8290692476

sudhirgastro@gmail.com 
Dr Madhumati Verma  Jaipur National University Institute for Medical Science and Research Centre  New RTO Office, Agra Road, Jagatpura,Jaipur,Rajasthan-302017
Jaipur
RAJASTHAN 		 9530150795

clinicalresearch@jnujaipur.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, JNU Institute for Medical Sciences and Research Centre  Approved 
Institutional Ethics Committee, JNU Institute for Medical Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MXP22 (Probiotic and antioxidant capsule  Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days 
Comparator Agent  Placebo (Microcrystalline cellulose and Talc)  Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult men and women aged ≥30 and ≤60 years, diagnosed with NAFLD within last 2 years.
2. CAP scores ≥248 and ≤270 dB/m indicating steatosis grade I/ II.
3. Non-alcoholics (little or no consumption of alcohol).
4. Willing to participate in the study with a signed and dated written consent.
5. Overweight and obese participant with BMI ≥25 kg/m2.
6. Having at least 3 of the following five metabolic risk factors:
i Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches).
ii Triglycerides >150 mg/dL.
iii Blood pressure ≥130 mm Hg (systolic, SBP) and/or ≥85 mm Hg (diastolic, DBP).
iv Fasting blood glucose ≥ 100 mg/ dl.
v Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL. 
 
ExclusionCriteria 
Details  1. Treatment of NAFLD for at least 3 months prior to the screening.
2. History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
3. Participants with liver cirrhosis, any concomitant liver disease.
4. Participants with systemic inflammatory disease or autoimmune disorders.
5. Participants with blood pressure ≥160 mm Hg (systolic, SBP) and/or ≥95 mm Hg (diastolic, DBP).
6. Participants with Fasting blood glucose ≥ 140 mg/ dl.
7. Participants with cardiopulmonary disease.
8. Heavy alcohol drinkers defined as follows:
i For men, consuming more than 4 drinks on any day or more than 14 drinks/week
ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week
9. Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis.
10. Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus.
11. Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F4.
12. Individuals with Inflammatory bowel diseases.
13. Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening.
14. Intake of probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk and proton pump inhibitor within one month before screening or during the study period.
15. Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions.
16. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
17. Regular use of a probiotic or prebiotic supplement within 3 months prior to screening.
18. Antibiotic use within 3 weeks prior to screening.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo.
 		 Day 0, Day 60 and Day 120
 
 
Secondary Outcome  
Outcome  TimePoints 
Liver health as assessed by the significant change in the AST & ALT levels from baseline as compared to that in placebo.  Day 0, 60 and 120 
Lipid profile as assessed by the significant change in the total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides from baseline to end point in comparison to the placebo.  Day 0, 60 and 120
 
The inflammatory factors as assessed by the change in IL-6 and TNF-α from baseline to end point in comparison to the placebo.  Day 0 and 120 
On dietary endotoxemia as assessed by the significant change in the serum Lipopolysaccharide level after a high fat diet  Day 0 and 120 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="59" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2022 
Date of Study Completion (India) 04/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   NIL 
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