| CTRI Number |
CTRI/2025/10/095545 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy of MOLEQURE-Liver Health in Liver Dysfunction |
|
Scientific Title of Study
|
A Non-randomized, Open-Labelled Pilot Study to Assess the Safety and Efficacy of MOLEQURE-Liver Health in Adult Subjects with Mild to Moderate Liver Dysfunction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srikanta Pandit |
| Designation |
Professor |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Centenary Heritage Building,
Research Unit
Clinical Trial Room No. 301-302, 170-172 Raja Dinendra Street, Kolkata 700004, West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srikanta Pandit |
| Designation |
Professor |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Centenary Heritage Building,
Research Unit
Clinical Trial Room No. 301-302, 170-172 Raja Dinendra Street, Kolkata 700004, West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srikanta Pandit |
| Designation |
Professor |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Centenary Heritage Building,
Research Unit
Clinical Trial Room No. 301-302, 170-172 Raja Dinendra Street, Kolkata 700004, West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.B. Roy State Ayurvedic Medical College and Hospital, 170-172 Raja Dinendra Street, Kolkata 700004, INDIA |
|
|
Primary Sponsor
|
| Name |
AMBITN LIFESCIENCES |
| Address |
Door No 130, Mooppil House, Mangattri,
Tirur, Mallappuram, Kerala, India, Pin 676105
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srikanta Pandit BAMS MD Ay PhD Ay |
J. B. Roy State Ayurvedic Medical College and Hospital |
Centenary Heritage Building, Research Unit, Clinical Trial Room 301-302, 170-172 Raja Dinendra Street, Kolkata 700004, West Bengal
Kolkata
WEST BENGAL |
09831723650
srikantapandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. 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: MOLEQURE-Liver Health, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: MOLEQURE-Liver Health capsule contain curcumin and cumin extract 3 percent each |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female volunteers aged 18-60 years.
2. Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (1x upper limit of normal or 1.5x upper limit of normal).
3. Subjects with liver dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right upper quadrant discomfort).
4. Willingness to comply with study procedures and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Known diagnosis of decompensated liver disease, including but not limited to ascites, hepatic encephalopathy, or variceal bleeding.
2. History of Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV infection.
3. Use of any medications, supplements, or herbal products specifically intended for the treatment or management of liver disorders within the last 30 days.
4. History of significant alcohol consumption, defined as above 60 ml of alcohol per day.
5. Presence of severe renal impairment, congestive heart failure, or significant psychiatric disorders that, in the investigator’s opinion, could interfere with study participation.
6. Pregnant or lactating women, or women planning to become pregnant during the study period.
7. Participation in any other clinical trial within 30 days prior to the screening visit.
8. Known hypersensitivity or allergy to any component of the study intervention.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in liver function biomarkers (ALT, AST, ALP, and bilirubin) throughout the study period |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life (QoL) from baseline as measured by 5-item World Health Organization Well-Being Index (WHO-5). |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/10/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
The primary objective is to assess the efficacy of MOLEQURE-Liver Health in reducing liver function parameters from baseline to the end of the study. The study is designed as a single-arm open-label pilot study in 24 participants. After selection, following inclusion and exclusion criteria, the participants will receive a 500 mg capsule (MOLEQURE-Liver Health) containing curcumin and cumin extract, twice daily for a duration of 12 weeks. The study will measure liver function biomarkers such as ALT, AST, ALP, and bilirubin, as well as improvements in clinical symptoms and the 5-item World Health Organization Well-Being Index (WHO-5). The study will also estimate safety laboratory parameters such as FBS, CBC, and kidney function tests, along with the occurrence of adverse events (AES). The statistical analysis for this study will include comparisons of efficacy variables using paired t-tests or Wilcoxon signed-rank tests, depending on the data distribution and study time points. Adverse events and other categorical data will be analyzed using frequency and percentage distributions. A p-value less than 0.05 will be considered statistically significant. |