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CTRI Number  CTRI/2023/06/053714 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Phase III clinical trial of Picroliv in the Management of Non-Alcoholic Fatty Liver Disease(NAFLD) 
Scientific Title of Study   A Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study on efficacy and safety of Standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) for 24 weeks in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CDRI-ICMR-6/2021 version 2.5 dated 7th December 2021  Protocol Number 
U1111-1272-3820  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Bhosale 
Designation  Principal Scientist 
Affiliation  CSIR-Central Drug Research Institute, Lucknow 
Address  Toxicology and Experimental Medicine, Lab No. PCN05,06 Sector 10, Jankipuram Extension, Sitapur road, Lucknow

Lucknow
UTTAR PRADESH
226031
India 
Phone  05222772487  
Fax    
Email  drvivekbhosale@cdri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Bhosale 
Designation  Principal Scientist 
Affiliation  CSIR-Central Drug Research Institute, Lucknow 
Address  Toxicology and Experimental Medicine, Lab No. PCN05,06 Sector 10, Jankipuram Extension, Sitapur road, Lucknow

Lucknow
UTTAR PRADESH
226031
India 
Phone  05222772487  
Fax    
Email  drvivekbhosale@cdri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Bhosale 
Designation  Principal Scientist 
Affiliation  CSIR-Central Drug Research Institute, Lucknow 
Address  Toxicology and Experimental Medicine, Lab No. PCN05,06 Sector 10, Jankipuram Extension, Sitapur road, Lucknow

Lucknow
UTTAR PRADESH
226031
India 
Phone  05222772487  
Fax    
Email  drvivekbhosale@cdri.res.in  
 
Source of Monetary or Material Support  
Baijnath Pharmaceuticals Pvt. Ltd. Vill.& P.O.Paprola, Teh. Baijnath, Dist Kangra, Himachal Pradesh 176115 
Marc laboratories Ltd. 3, Vidhan Sabha Marg, Sushanpura, Crossing, Hazratganj, Lucknow, Uttar Pradesh 226001 
 
Primary Sponsor  
Name  Director, CSIR-Central Drug Research Institute 
Address  Sector 10, Jankipuram Extension, Sitapur road, Lucknow 226031 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
CSIR Institute of Himalayan Bioresource Technology CSIRIHBT  Palampur - 176061 (H.P.) INDIA 
Indian Council of Medical Research ICMR  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalimar  All India Institute of Medical Sciences (AIIMS)  Dept. of gastroenterology, second floor in the main building – AB2 ward, Ansari Nagar, New Delhi 110029
New Delhi
DELHI 		 011-26588500

drshalimar@gmail.com 
Dr Shiv Kumar Sarin  Institute of Liver and Biliary Sciences (ILBS)  Director, D-1 Vasant Kunj, New Delhi, Pin code: 110070
New Delhi
DELHI 		 011-46300000

shivsarin@gmail.com 
Dr Akash Shukla  King Edward VII Memorial Hospital (KEMH)  Dept of gastroenterology, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 02224107000

drakashshukla@yahoo.com 
Dr Satyendra Kumar Sonakar  King’s George Medical University (KGMU)  Dept. of medicine, above gandhi ward,Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 05222258880

satyendra.sonkar@gmail.com 
Dr Sukanya Bhrugumalla  Nizam’s Institute of Medical Sciences (NIMS)  Dept. og Gastroenterology, Punjagutta Rd, Punjagutta Market, Punjagutta, Hyderabad, Telangana
Hyderabad
TELANGANA 		 04023489000

sukanyab92@gmail.com 
Dr Ajay Kumar Duseja  Post-Graduate Institute of Medical Education and Research, (PGIMER)  Dept. of Gastroenterology, Sector-12, Chandigarh, Pin- 160 012
Chandigarh
CHANDIGARH 		 0172-2747585

ajayduseja@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi  Approved 
Institutional ethics Committee, Institute of Liver and Biliary Sciences (ILBS), New Delhi  Submittted/Under Review 
Institutional ethics Committee, Nizam’s Institute of Medical Sciences (NIMS), Hyderabad  Submittted/Under Review 
Institutional ethics Committee, Post-Graduate Institute of Medical Education and Research, (PGIMER  Submittted/Under Review 
Institutional ethics Committee, Research cell Administrative block, King George’s Medical University  Approved 
Institutional ethics Committee, Seth Gordhandas Sunderdas Medical College (GSMC) and King Edward VII Memorial Hospital (KEMH), Parel Mumbai  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Picroliv 100mg twice daily  Picroliv 100mg twice daily for 24 weeks + standard therapy of NAFLD 
Comparator Agent  Placebo  Placebo for 24 weeks+ standard therapy of NAFLD  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  3. Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening
4. Liver enzymes normal or above the ULN (upper limit of Normal Range) but less than 3 times
5. Adults who are diagnosed with uncomplicated NAFLD (fibrosis score up to F2) by transient elastography.
6. Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L
7. HbA1c < 7%  
 
ExclusionCriteria 
Details  1. Significant alcohol consumption (> 210 g/week in males and > 70 g/week in females)
2. eGFR < 60 mL/min / 1.73m2 or patients on dialysis
3. Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases
4. Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
5. Pregnant and lactating women.
6. Not willing to provide written informed consent
7. Females unwilling to use any form of contraception during the trial.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)   Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)  
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to Week 24 in hepatic stiffness by transient elastography  0 and 24 weeks 
Change from baseline to week 24 in clinical laboratory variables of Liver function   0, 12, 24 weeks 
Change from baseline to week 24 in clinical laboratory variables of lipid profile   0,12,24 weeks 
Change from baseline to week 24 in Liver indices / scores – NAFLD fibrosis score, FIB4 index, ELF score, Fatty Liver Index, APRI..  0,12,24 weeks 
Change in baseline clinical signs and symptoms at every follow up: Low appetite, distaste, heaviness of the abdomen, constipation, inactivity stiffness, fatigue, pain in right upper abdomen and any other   0,2,4, 8, 12, 18, 24 weeks 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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   Phase 3 
Date of First Enrollment (India)   07/07/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvivekbhosale@cdri.res.in].

  6. For how long will this data be available start date provided 09-12-2024 and end date provided 08-12-2028?
    Response (Others) -  As per publisher policy who accept manuscript

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem worldwide, affecting between 25% and 30% of the general population. NAFLD refers to a spectrum ranging from noninflammatory isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by steatosis, necroinflammatory changes, and varying degrees of liver fibrosis. Picrorhiza kurroa is a well-known herb in the Ayurvedic system of medicine and has traditionally been used to treat disorders of the liver. It is antioxidant and has anti-inflammatory activities. The use of Picroliv which is standardized as per phytopharmaceutical guidelines of Govt. of India for the treatment of NAFLD will be safe and effective.

 
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