| CTRI Number |
CTRI/2025/08/093068 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate effects of Alpha Keto Analogues of essential amino acids in patients with hepatic encephalopathy |
|
Scientific Title of Study
|
A prospective, single center, randomized, open label, two arm clinical study to evaluate the effects of Alpha Keto Analogues of essential amino acids with standard of care versus standard of care alone in patients with hepatic encephalopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay Kumar |
| Designation |
Consultant Gastroenterology |
| Affiliation |
GSVM Medical Collage |
| Address |
GSVM Medical Collage
Swaroop Nagar, Kanpur, Uttar Pradesh 208002
GSVM Medical Collage
Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8004877113 |
| Fax |
|
| Email |
dr.vinayksachan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar |
| Designation |
Consultant Gastroenterology |
| Affiliation |
GSVM Medical Collage |
| Address |
GSVM Medical Collage
Swaroop Nagar, Kanpur, Uttar Pradesh 208002
GSVM Medical Collage
Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8004877113 |
| Fax |
|
| Email |
dr.vinayksachan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh S Ray |
| Designation |
Research Associate |
| Affiliation |
Department of Clinical Trial, RYT Life Sciences Pvt. Ltd. |
| Address |
205/1 Shilp Arcade,LBS Road,Hirawadi, Bapunagar- Ahmadabad-GUJARAT-382345-
India
205/1 Shilp Arcade,LBS Road,Hirawadi, Bapunagar- Ahmadabad-GUJARAT-382345-
India
Ahmadabad
GUJARAT
382345
India |
| Phone |
7778866235 |
| Fax |
|
| Email |
rakesh@rytlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Dr Vinay Kumar
Consultant Gastroenterology
GSVM Medical Collage
Swaroop Nagar, Kanpur, Uttar Pradesh 208002 |
|
|
Primary Sponsor
|
| Name |
Dr Vinay Kumar |
| Address |
GSVM Medical Collage Swaroop Nagar, Kanpur, Uttar Pradesh 208002 |
| Type of Sponsor |
Other [Investigator funded] |
|
|
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 Vinay Kumar |
GSVM Medical College |
Department of Gastroenterology, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
8004877113
dr.vinayksachan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College Kanpur |
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 |
Alpha Keto Analogues Tablet with standard of care |
Alpha Keto Analogues of essential amino acids tablet will be given as add on to standard of care for 90 days |
| Comparator Agent |
Standard of care |
Standard of care treatment will be provided by the investigator for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 65 years male and female both.
2. Cirrhosis diagnosed on the basis of clinical features, biochemical, radiological and or liver histology data.
3. Diagnosed with hepatic encephalopathy having Grade 2 and 3
4. Diagnosed with hepatic encephalopathy at least 7 days prior to screening.
5. Ammonia level more than 170.
|
|
| ExclusionCriteria |
| Details |
1. Current or recent (less than 6 weeks) use of alcohol
2. Use of antibiotics within last 6 weeks
3. Use of lactulose, lactitol, L-ornithine L-aspartate and zinc within the last 6 weeks
4. Use of interferon or psychoactive drugs like benzodiazepines, psychotropic drugs, anti-epileptics within the last 6 weeks
5. Infection or gastrointestinal hemorrhage within the last 6 weeks
6. Advanced medical problems like congestive cardiac failure, advanced pulmonary disease or renal insufficiency or electrolyte imbalance
7. Hepatocellular carcinoma
8. History of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
9. Pregnancy and breastfeeding
10. Neurological or psychiatric problems which may influence quality of life measurement.
11. Poor vision or motor defects which interfere with the performance of psychometric tests.
12. Any condition which may not appropriate for study result as per PI discretion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in arterial ammonia concentration from baseline |
Screening, day 30, day 60, day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in grades of hepatic encephalopathy |
Screening, Day 90 |
| Reduction of ammonia level to at least 50% from the baseline at the end of treatment. |
Baseline, Day 90 |
| Improvement in quality of life using EQ-5D |
Baseline, Day 90 |
| Mental State Examination using MMSE |
Baseline, Day 90 |
| Adverse Events |
Screening, Day 0, day 30, day 60, day 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0"
Months="11"
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
|
This is a randomized, controlled, prospective clinical study with a total participation duration of up to 94 days for each subject, starting from the day of enrolment. The study will begin with a screening visit (Visit 1) conducted between Day -3 and Day -1 to assess eligibility. Eligible subjects will undergo randomization at the baseline visit (Visit 2) on Day 0. The treatment period will span approximately three months, during which participants will attend follow-up visits on Day 30 (±4 days), Day 60 (±4 days), and Day 90 (±4 days). The primary endpoints of the study include changes in arterial ammonia levels. Secondary endpoints include improvement in quality of life and mental state examination scores. Adverse events will be monitored throughout the study period. |