| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E713||Disorders of fatty-acid metabolism. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: - | | 2 | Comparator Arm | Drug | Other 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 |