| CTRI Number |
CTRI/2022/12/048588 [Registered on: 29/12/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate safety/tolerability and the efficacy of Supplement to improve function of liver in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD). |
|
Scientific Title of Study
|
A randomized, double blinded, placebo controlled, dose ranging, parallel group study to evaluate safety/tolerability and the efficacy of AMINO ACID SUPPLEMENTATION to improve liver function in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS/22/004, Version 00, Date: 01 Nov 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Service |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.
Road, Satellite.
Ahmadabad
GUJARAT
380015
India
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Service |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.
Road, Satellite.
Ahmadabad
GUJARAT
380015
India
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Service |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.
Road, Satellite.
Ahmadabad
GUJARAT
380015
India
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
| Sundyota Numandis Probioceuticals Pvt. Ltd.
7th Floor, Safal Pegasus Tower-A, Prahladnagar, Ahmedabad – 380015, India |
|
|
Primary Sponsor
|
| Name |
Sundyota Numandis Probioceuticals Pvt. Ltd. |
| Address |
7th Floor, 705-708 Tower A, Safal Pegasus Prahalad Nagar, Ahmedabad-380015 (Gujarat-INDIA) |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Cysbio ApS |
Agern Alle 1, 2970 Hørsholm, Denmark
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devendra Gadhadra |
Shakti Super Specialty Hospital |
Shakti Super Specialty Hospital , A-ll7, 1st Floor, Krishna Complex B/h. Shahwadi Bus Stand Nr. Petrol Pump, Narolgam, Ahmedabad, Gujarat 382405.
Ahmadabad
GUJARAT |
9374643422
gadhadradevendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medilink Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amino Acid Supplementation |
Powdered sachet (approx. 6 gm) to be mixed with 150-200 ml
water for oral intake three times a day for 84 days. |
| Comparator Agent |
Placebo |
Powdered sachet (approx. 6 gm) to be mixed with 150-200 ml water for oral intake three times a day for 84 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects between 20-50 years of age (both inclusive) with Non-Alcoholic fatty Liver Disease (Grade I & II).
2. Subject has provided written, signed and dated informed consent to participate in the study.
3. Subject is willing and able to comply with the protocol. |
|
| ExclusionCriteria |
| Details |
1. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
2. Subject has a history of alcohol or other drug abuse in the past year.
3. Subject has a known allergy or sensitivity to any ingredient in the test product.
4. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
5. Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements.
6. Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and alpha-1 antitrypsin deficiency).
7. Subjects with accidental cases like injury, all types of anemias.
8.Subjects with Hemophilia, Thalassemia, case of poisoning, alcoholic liver, Alcoholic chronic liver disease, Decompensated cirrhosis.
9. Chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson disease, deficits of alpha-1 antitrypsin, celiac disease.
10. Diseases, eczema, skin diseases/ allergy.
11.Malnutrition
12. Severe renal, cardiac or respiratory insufficiency.
13. Malignant tumors
14. Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass
surgery.
15. Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil.
16. Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter).
17. Contraindication to liver biopsy.
18. Concomitant disease with reduced life expectancy.
19. Severe psychiatric conditions.
20. Pregnant and breast feeding women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change in Fatty Liver Index
2) Change in Liver Stiffness (USG-Liver) |
Baseline and 84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Incidence and Number of AEs and SAEs. |
Baseline and 84 days |
| 2) Change in GSG Index (Glutamate serine glycine) |
Baseline and 84 days |
| 3) Change in QUICKI Index |
Baseline and 84 days |
| 4) Change in Weight |
Baseline and 84 days |
| 5) Change in BMI |
Baseline and 84 days |
| 6) Change in laboratory parameters from baseline |
Baseline and 84 days |
| 7) Improvement in Quality of Life |
Baseline and 84 days |
| 8) Change in HOMA-IR |
Baseline and 84 days |
| 9) Changes in vital parameters |
Baseline and 84 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="103" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/01/2023 |
| Date of Study Completion (India) |
02/05/2023 |
| 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
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted to evaluate the safety/tolerability and the efficacy of Amino Acid Supplementation to improve liver function in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD). Sufficient number of subjects will be enrolled in the study to get 100 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit 1 will be screening visit. Follow up visit 2 will be on 28 ± 2 days, Follow up visit 3 will be on 56 ± 2 days and end of study visit will be on 84 ± 2 days. Subjects will be screened for the eligibility criteria during screening visit.
Subjects will be instructed to mix the sachets containing powder (approx. 6 gm) with 150-200 ml water for oral intake three times a day. The subjects will be divided into 5 groups and in each arm 22 subjects will be enrolled. Arm 1: 3 Placebo Sachets, Arm 2: Supplement Mix- 1 sachet + 2 Placebo sachets, Arm 3: Supplement Mix- 2 sachets + 1 Placebo sachet, Arm 4: Supplement Mix- 3 sachets, Arm 5: Comparator supplement Mix 2 sachets + 1 Placebo sachet. Primary endpoint will be change in Fatty Liver Index and Liver Stiffness (USG-Liver) from baseline and at the end of study. The secondary endpoint will be change in GSG Index (Glutamate serine glycine), QUICKI Index, weight, BMI, laboratory parameters, quality of Life, HOMA-IR will be checked from baseline and at the end of study. |