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CTRI Number  CTRI/2026/01/100484 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 10/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study to evaluate HLTX-072522 for the safety and improvement in liver parameters in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Placebo-Controlled, Two-arm, Comparative, Multicentric Clinical Study to Evaluate the Safety and Efficacy of HLTX-072522 in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). 
Trial Acronym  MASLD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Utsa Basu 
Designation  MBBS consultant physician and diabetologist 
Affiliation  Dr Utsa Basu Clinic. 
Address  Dr Utsa Basus Clinic, 65A Middle Road, Entally, Kolkata-700014.

Kolkata
WEST BENGAL
700014
India 
Phone  9432658968  
Fax    
Email  dr.utsabasu@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumawat 
Designation  Head Medical Services and Clinical Development 
Affiliation  Himalaya Wellness Company 
Address  Room No 301 3rd Floor Medical Services and Clinical Development (R&D) Makali

Bangalore
KARNATAKA
562162
India 
Phone  08067549904  
Fax    
Email  rajesh.kumawat@himalayawellness.com  
 
Details of Contact Person
Public Query
 
Name  Dr Soorya Narayan H 
Designation  Manager Clinical Operations  
Affiliation  Himalaya Wellness Company 
Address  Room No 301 3rd Floor Medical Services and Clinical Development R and D Makali

Bangalore
KARNATAKA
562162
India 
Phone  08067549919  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company Makali Bangalore Karnataka 562162 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Makali Bangalore 562162 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasad Bhate  Accord Hospitals  Room No NA, Ground Floor Moshi Pradhikaran Pimpri-Chinchwad Pune Maharashtra 412105
Pune
MAHARASHTRA 
9920039265

prasadbhate07@gmail.com 
Dr Ramendar Bahadur Singh Tomar  Atmaram Hospitals   Room No NA Ground Floor 3/128 Y block Naubasta Kanpur, Uttar Pradesh 208021
Kanpur Nagar
UTTAR PRADESH 
9621256741

tomar1283@gmail.com 
Dr Utsa Basu  Dr. Utsa Basu clinic  Room No 03 ground floor Dr Utsa Basus Clinic, 65A Middle Road, Entally, Kolkata-700014.
Kolkata
WEST BENGAL 
9432658968

dr.utsabasu@yahoo.com 
Dr Manoj Kumar  Jawahar Lal Nehru Medical College  Room No NA, Floor NA Kala Bagh, Ajmer Rajasthan-305001
Ajmer
RAJASTHAN 
9468964902

drmanoj.clinical@gmail.com 
Dr Umesh M Jalihal  Karnataka Gastro Centre  Room No NA Floor NA 748 5th Main 2nd Stage West of Chord Road 11th Cross Mahalakshmipuram Bangalore 560 086.
Bangalore
KARNATAKA 
9945190666

kargastro@gmail.com 
Dr Rekha Patil  KLE Dr Prabakar Kore Hospital  Room No 11 General medicine OPD ground floor KLEs Dr Prabhakar Kore Hospital MRC Nehru Nagar Belgaum 590010
Belgaum
KARNATAKA 
944837125

drrekhaspatil@gmail.com 
Dr Hemant Kumar Gupta   Samvedna Hospital  Room no NA Ground floor, B 27/88 G New Colony Ravindrapuri Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 
8573888800

hemantkrg26@gmail.com  
Dr N A Rajesh  SRM Medical College Hospital and Research Centre,   Room No NA 4th floor SRM Nagar SRM Institute of Science and Technology Kattankulathur 603 203.
Kancheepuram
TAMIL NADU 
9621256741

piclinicaltrials@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Apex Hospital Institutional Ethics Committee  Approved 
Ethics Committee Atmaram Child Care and Critical Care  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee of Accord Hospital  Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Karnataka Gastro Center Ethics Committee  Approved 
SRM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E713||Disorders of fatty-acid metabolism. Ayurveda Condition: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: HLTX-072522, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult male and female participants aged between 18 and 60 years.
2. Diagnosed with Metabolic dysfunction-associated steatotic liver disease defined as hepatic steatosis in adultsdetected either by imaging techniques or biopsy
3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness with 8 to 10 Kpa 
 
ExclusionCriteria 
Details  1. LSM score more than 10kpa Fibrosis stage F3 to F4 confirmed through Fibroscan VCTE.
2. History of histologically confirmed MASLD with advanced fibrosis stage F4.
3. History of Cirrhosis or its complications
Elevated liver parameters ALT, AST, ALP more than 5 times ULN and Total Bilirubin more 3 times ULN 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in Liver Stiffness Measurement [(LSM); fibrosis] score through VCTE from baseline to EOS.
2. Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE from baseline to EOS. 
Visit 1: Screening (-14 days to Day 0)
Visit 2: Baseline/ Day 1
Visit 3: Day 30± 3 days
Visit 4: Day 60± 3 days/ Telephonic visit
Visit 5: Day 90± 3 days
Visit 6: Day 135±3 days/ Telephonic visit
Visit 7: Day 180±3 days/ EOS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in BMI and/or Waist circumference at baseline, visit 3, visit 5 and EOS.
2. Change in Lipid Profile (HDL, Triglycerides) from baseline to EOS.
3. Change in HbA1C at baseline, visit 5, and EOS.
4. Change in Fasting serum glucose level at baseline, visit 3, visit 5 and EOS.
5. Change in Systolic BP and Diastolic BP from baseline to EOS.
6. Change in Liver function test (AST, ALT, ALP, Total bilirubin) at baseline, visit 3, visit 5 and EOS.
7.Incidence of adverse events during the study period. 
Visit 1: Screening (-14 days to Day 0)
Visit 2: Baseline/ Day 1
Visit 3: Day 30± 3 days
Visit 4: Day 60± 3 days/ Telephonic visit
Visit 5: Day 90± 3 days
Visit 6: Day 135±3 days/ Telephonic visit
Visit 7: Day 180±3 days/ EOS 
Improvement in quality of life from baseline to EOS using questionnaire.  Visit 2:Baseline/Day 1
Visit 7:Day 180±3 days/ EOS 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2 
Date of First Enrollment (India)   05/02/2026 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Participants will be examined for eligibility during the screening period after signing the informed consent form (within 14days prior to Baseline). An adequate number of participants will be screened to enroll 120 participants, to have at least 100 evaluable participants.
Participants will be enrolled based on study eligibility criteria (inclusion and exclusion criteria). After signing the informed consent form, eligible participants will be randomized as per randomization schedule either into active or in the placebo arm. All the participants will be given IP (active or placebo) on the same day. The date of first IP administration will be considered as Day1 and instructions about the dosage and timings will be given by Investigator as described in dosage & administration section.
Core Endpoints
Change in Liver Stiffness Measurement [(LSM); fibrosis] score through VCTE.
Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE.
Exploratory Endpoints
Change in BMI and/or Waist circumference
Change in Lipid Profile (HDL, Triglycerides)
Change in HbA1C, Fasting serum glucose level
Change in Systolic BP and Diastolic BP
Change in Liver function test (AST, ALT, ALP, Total bilirubin)
In the participants where these parameters have clinical significance at the baseline. The details will be mentioned in SAP.
Assessment of quality of life using questionnaire
Incidence of adverse events during the study period
There will be a total of 7 study visits for each participant.
Visit 1: Screening (-14 days to Day 0)
Visit 2: Baseline/ Day 1
Visit 3: Day 30± 3 days
Visit 4: Day 60± 3 days/ Telephonic visit
Visit 5: Day 90± 3 days
Visit 6: Day 135±3 days/ Telephonic visit
Visit 7: Day 180±3 days/ EOS
 
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