| CTRI Number |
CTRI/2025/02/081034 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The trial is to Evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in participants with deranged liver function. |
|
Scientific Title of Study
|
An Open Label, Randomized, single center Clinical Trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in subjects with deranged liver function |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DLF/CT/2025, Version 1.0, Dated 13-Jan-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipti Gupta |
| Designation |
Consultant Physician |
| Affiliation |
Tulsi Multispeciality Hospital |
| Address |
Clinical Research Room, Ground Floor,B-1 Loni Rd West Jyoti Nagar Jyoti Nagar West.
East
DELHI
110094
India |
| Phone |
9811676049 |
| Fax |
|
| Email |
drdipti16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Gupta |
| Designation |
Consultant Physician |
| Affiliation |
Tulsi Multispeciality Hospital |
| Address |
Clinical Research Room, Ground Floor,B-1 Loni Rd West Jyoti Nagar Jyoti Nagar West.
Jyoti Nagar Shahdara Delhi
East
DELHI
110094
India |
| Phone |
9811676049 |
| Fax |
|
| Email |
drdipti16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director- Clinical Trial Operations |
| Affiliation |
IR Innovate Research Pvt Ltd |
| Address |
Building No. C-120, 3rd Floor, IR Innovate Research Pvt Ltd
Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Sunpure Extracts Private Limited,Sunpure House, Plot No. 11/29, Site-4, Sahibabad Industrial Area, Sahibabad, Ghaziabad, Uttar Pradesh 201010 |
|
|
Primary Sponsor
|
| Name |
Sunpure Extracts Private Limited |
| Address |
Sunpure House, Plot No. 11/29, Site-4, Sahibabad Industrial Area, Sahibabad, Ghaziabad, Uttar Pradesh 201010 |
| 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 |
| DrDipti Gupta |
Tulsi Multispeciality Hospital. |
Clinical Research Room, Ground Floor,B-1 Loni Rd West Jyoti Nagar Jyoti Nagar West.
New Delhi
DELHI |
9811676049
drdipti16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CentralIndependentEthicsCommittee-CIEC CentralIndependentEthicsCommittee-CIEC |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CurcuBoost capsule |
Dose- 1 capsule 500 mg of CurcuBoost to be taken once a day, orally with plain water after meal for 84 +/- 3 days or 12 Weeks. |
| Comparator Agent |
Standard of Care |
Subjects in comparator arm will receive allowed Standard of Care as per protocol and in judgment of Investigator for 84 +/- 3 days or 12 Weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18–75 years
2. Diagnosis of Liver Dysfunction:
Biochemical evidence of liver dysfunction, including elevated liver enzymes (e.g., ALT, AST, ALP, GGT, and/or bilirubin)
Serum total bilirubin level greater than ULN &less than or equal to 3 times ULN.
AST or ALT or ALP greater than 3 times ULN &less than or equal to 5 times ULN.
GGT greater than ULN & less than or equal 2 times ULN
3.Chronic liver conditions, such as:
Non-alcoholic fatty liver disease (NAFLD)
Non-alcoholic steatohepatitis (NASH)
Chronic hepatitis (e.g., hepatitis B, C, or autoimmune hepatitis)
Early liver fibrosis or cirrhosis (confirmed via imaging like elastography or biomarker indices like FIB-4 or APRI)
Alcohol-related liver disease (if participants are not actively consuming alcohol).
4.Stable Health:
Stable liver function and no active acute liver disease (e.g., no acute viral hepatitis or decompensated cirrhosis).
No significant uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
5.Informed Consent:
Ability to provide written informed consent and adhere to study protocol.
6.Willingness to comply:
Willingness to adhere to study requirements, including taking curcumin and attending all follow-up visits
|
|
| ExclusionCriteria |
| Details |
A subject will be considered unsuitable for the study if they meet any one of the following criteria:
1.Severe Liver Disease:
Decompensated cirrhosis (e.g., presence of ascites, variceal bleeding, hepatic encephalopathy).
End-stage liver disease (e.g., MELD score greater than 15, liver transplant candidates).
Acute liver failure or severe acute hepatotoxicity.
2.Other Major Medical Conditions:
Active cancer, except for non-invasive skin cancers (e.g., basal cell carcinoma).
Severe cardiovascular diseases, such as recent myocardial infarction or congestive heart failure require hospitalization.
3.Pregnancy and Lactation:
Pregnant or breastfeeding women.
Women of childbearing potential not using effective contraception.
4.Drug and Substance Use:
Active alcohol or drug abuse (substance abuse that may interfere with liver function or study compliance).
Use of hepatotoxic medications, including certain chemotherapy agents, and anticoagulants (unless stable and managed).
Use of curcumin or turmeric supplements within 30 days prior to enrollment.
5.Gastrointestinal Disorders:
History of active gastrointestinal disease (e.g., peptic ulcer disease, inflammatory bowel disease, gastrointestinal bleeding), which could affect curcumin absorption or safety.
6.Allergy/Intolerance:
Known hypersensitivity to curcumin, turmeric, or any study-related components, such as pipeline.
7.Comorbidities and Medications:
Use of immunosuppressive drugs or chronic use of NSAIDs or other anti-inflammatory medications that could confound the effects of curcumin.
History of non-compliance with medical treatments or clinical study protocols.
8.Other Confounding Factors:
Participation in other clinical trials that may interfere with the outcomes of this study.
Patients who are unlikely to complete the study (e.g., those with mental or psychological conditions that would prevent adherence).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary measure of efficacy would be the change in serum liver enzyme levels (ALT, AST, ALP, GGT) from baseline to the end of the study |
Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes are to Changes in Liver Disease Quality of Life (LDQOL) score from baseline to the end of the study (Week 12) and Adverse events and severe adverse events throughout the study |
Week 12 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This open-label, randomized, single-center clinical
trial aims to assess the potential benefits of CurcuBoost® when added to the
standard of care in subjects with deranged liver function. By comparing
outcomes with standard of care alone, this study seeks to establish whether
CurcuBoost® can provide additional therapeutic benefits, including improvements
in liver function parameters, quality of life, and overall safety and
tolerability in individuals with liver dysfunction. The primary measure of
efficacy would be the change in serum liver enzyme levels (ALT, AST, ALP, GGT)
from baseline to the end of the study (Week 12) and the
Secondary measures Changes in Liver Disease Quality of Life (LDQOL)
score from baseline to the end of the study (Week 12) and Adverse events and
severe adverse events throughout the study. CurcuBoost + SOC, 1 capsule 500 mg to be taken once a day, orally with
plain water after meal for 84+ 3 days or 12 Weeks.
SOC, Subjects in comparator arm will receive allowed
Standard of Care as per protocol and in judgment of Investigator for 84 +
3 days or 12 Weeks.
|