| CTRI Number |
CTRI/2024/12/078148 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
HDLD-092320 for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Two-arm, Comparative, Multicentric, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of HDLD-092320 in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
|
| Trial Acronym |
MASLD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/053/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Kumar Gupta |
| Designation |
Gastroenterology |
| Affiliation |
Samvedna Hospital |
| Address |
Samvedna Hospital Gastroenterology department wing B ground floor B 27 88 G New Colony Ravindrapuri
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8573888800 |
| Fax |
|
| Email |
hemantkrg26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head - Medical services & Clinical development |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room no 302 3rd floor Medical services and clinical development department Himalaya Wellness Company Makali
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549904 |
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Nayaran H |
| Designation |
Manager - Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
3rd floor Medical services and clinical development department Himalaya Wellness Company Makali
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company
Makali Bengalore 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 = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrManoj Kumar |
JLN Medical College |
Kala Bagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN |
8118877284
drmanoj.clinical@gmail.com |
| Dr Prasad Bhate |
Accord Hospital |
spine road, beside FDA, Moshi Pradhikaran
Pune
MAHARASHTRA |
9920039265
prasadbhate07@gmail.com |
| Dr Anurag Sachan |
Atmaram Healthcare Hospital |
Atmaram Healthcare 56Y Naubasta Kanpur UP 208011
Kanpur Nagar
UTTAR PRADESH |
9501698862
dranuragsachandm@gmail.com |
| Dr Rahul Yadav |
Medical Care Centre and Hospital |
Opposite Namaskar In Style Kanpur Road, Alambagh Lucknow 226005
Lucknow
UTTAR PRADESH |
9415888888
drrahulyadav1980@gmail.com |
| Dr Hemanth Kumar Gupta |
Samvedna Hospital |
B 27/88 G, New Colony, Ravindrapuri, Varanasi, 221005. Uttar Pradesh
Varanasi
UTTAR PRADESH |
8573888800
hemantkrg26@gmail.com |
| DrShyam Sunder Sharma |
Sharma Gastroentrology Centre |
107, Gandhipath, Lane Number- 3, Queens Road, Guru Jhambeshwar Nagar, Vaishali Nagar, Jaipur – 302021
Jaipur
RAJASTHAN |
9619425556
shyamsharma4@rediffmail.com |
| DrNARajesh |
SRM |
Department of Gastroentrology Kattankulathur. Chennai
Chennai
TAMIL NADU |
9629006644
piclinicaltrials@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Asopa Ethics Committee |
Approved |
| Central Independent Ethics Committee |
Approved |
| Ethics Committee Atmaram child care and critical care |
Approved |
| Institutional Ethics Committee |
Approved |
| Samvedna Hospital 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: E70-E88||Metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HDLD-092320 |
Investigational Product
Two tablets twice daily orally after food for 180 days |
| Comparator Agent |
Placebo |
Placebo
Two tablets twice daily orally after food for 180 days. |
|
|
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 adults detected either by imaging techniques or biopsy
3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness with 8 to 12 Kpa
|
|
| ExclusionCriteria |
| Details |
1. LSM score more than 12kpa Fibrosis stage F3 to F4 confirmed through Fibroscan VCTE.
2. History of histologically confirmed MASLD with advanced fibrosis stage F3 & 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.
2. Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE
|
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
2. Change in Lipid Profile (HDL, Triglycerides)
3. Change in HbA1C, Fasting serum glucose level
4. Change in Systolic BP and Diastolic BP
5. Change in Liver function test (AST, ALT, ALP, Total bilirubin)
6. Assessment of quality of life using questionnaires.
7. Incidence of adverse events
|
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
|
|
|
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)
|
24/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 14 days prior to Baseline). An adequate number of participants will be screened to enroll 120 participants, to have atleast 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 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
|