| CTRI Number |
CTRI/2022/07/043725 [Registered on: 05/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of Livercure Tablets on Patients with Liver Cirrhosis. |
|
Scientific Title of Study
|
Clinical Study to evaluate the safety and efficacy of Livercure tablets on patients with Liver Cirrhosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2201 ver 1.0 dated 05 May 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SatyaPrakash B S |
| Designation |
Gastroenterologist |
| Affiliation |
Dr Satyaprakashs Centre for Digestive and Liver Diseases |
| Address |
Dr Satyaprakashs Centre for Digestive and Liver Diseases
DoorNo 229 14th Cross Road
Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Phone |
6364147979 |
| Fax |
|
| Email |
info@samahitha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SriVatsa G S |
| Designation |
Managing Director |
| Affiliation |
Samahitha Research Solutions |
| Address |
No 1204 ASHVA second floor 26th main road
Jayanagar 9th block
Bangalore
KARNATAKA
560069
India |
| Phone |
6364147979 |
| Fax |
|
| Email |
sri@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Shetty |
| Designation |
Project Manager |
| Affiliation |
Samahitha Research Solutions |
| Address |
No 1204 ASHVA second floor 26th main road
Jayanagar 9th block
Bangalore
KARNATAKA
560069
India |
| Phone |
6364147979 |
| Fax |
|
| Email |
disha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Jammi Pharmaceuticals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Jammi Pharmaceuticals Pvt Ltd |
| Address |
121 Jammi Buildings Royapettah High Road
Chennai 600 004
|
| 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 SatyaPrakash B S |
Dr. Satyaprakash Centre for Digestive and Liver Diseases |
Dr. Satyaprakashs Centre for Digestive and Liver Diseases
Door No.229, 14th Cross Rd, Vijayanagar
Bangalore
KARNATAKA |
6364147979
info@samahitha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K745||Biliary cirrhosis, unspecified. Ayurveda Condition: yakrit vriddhi, (2) ICD-10 Condition:K745||Biliary cirrhosis, unspecified. Ayurveda Condition: YAKRUJJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Livercure , Reference: Ayurvedic pharmacopoeia of India, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged between 18 to 70 years with a confirmed diagnosis of liver cirrhosis (diagnosed by clinical, biochemical, sonographic or histological evidence of cirrhosis and portal hypertension).
2 Evidence of decompensated liver disease at screening (e.g., Child class B or C, Child-Pugh scores of ≥7).
3 MELD scores of at least 10 (UNOS Meld calculator).
4 AFP Level < 400ng/ml.
5 Signed informed consent.
6 Excessive consumption of alcohol (>30 gm of absolute alcohol/day) use in the last 3 months before screening can be included
7 Positive HBsAg or antibodies to HCV
|
|
| ExclusionCriteria |
| Details |
1 Patients likely to undergo liver transplantation during the duration of the study.
2 Presence of advanced hepatic encephalopathy Grades 3 and 4 at the time of screening- Annexure V.
3 Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
4 Platelet count < 30,000/mm3.
5 Serum Sodium <129mEq/L.
6 Serum Creatinine > 2 mg/dl.
7 Hepatocellular carcinoma or other malignancies
8 Active infectious disease.
9 Presence of severe underlying cardiac, pulmonary or renal disease.
10 Positive antibodies to HIV
11 Pregnancy or lactating women
12 Actively participating in in other clinical trial or has participated in a clinical trial within the last 30 days.
13 Unwilling/unable to sign the informed consent
14 Any condition in the opinion of the investigator that may compromise the safety of the patient by participating in this study. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints
•Improved liver function as demonstrated by USG
•Improved liver function as demonstrated by LFT
•Change in MELD and Child-Pugh Score
•Improvement in quality of life as assessed by SF 36 questionnaire |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety parameters like RFT, LFT, Hematology and biochemistry, Vitals during the study |
Day 90, 180, 270 and 360 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
01/08/2022 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open-labeled, single-arm, prospective clinical study to evaluate the safety and efficacy of Tablet Livercure Complex Forte with Nutritone granules therapy in patients diagnosed with liver cirrhosis (stages 1 and 2)Primary Objective ï‚· To evaluate the efficacy of Tablet. Livercure Complex Forte with Nutritone granules 12 months of therapy in subjects diagnosed with Liver Cirrhosis ï‚· To evaluate the change in the quality of life after 12 months of treatment with Tablet. Livercure Complex forte with Nutritone granules.
Secondary Objective ï‚· To evaluate the safety of Livercure Complex Forte with Nutritone granules in subjects diagnosed with Liver Cirrhosis. |