| CTRI Number |
CTRI/2025/12/099672 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy Study of Phyllanthus niruri 6C in Adults with Grade 2 Fatty Liver Disease |
|
Scientific Title of Study
|
A Prospective Single-Arm Interventional Study To Assess The Safety And Efficacy Of Phyllanthus Niruri 6C In Patients With Grade 2 Fatty Liver |
| 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 Koppineedi Lakshmi Prasanthi |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD 7
Department of Materia Medica
JIMS Homoeopathic Medical College and Hospital Srirama nagar Munchital Hyderabad
Hyderabad TELANGANA 509325 India |
| Phone |
9426909664 |
| Fax |
04023470444 |
| Email |
k.lakshmiprasanthi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Samar Chatterjee |
| Designation |
Proffessor |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD no 7 Department of Materia medica JIMS Homoeopathic Medical College and Hospital Srirama nagar Munchital Hyderabad
Hyderabad TELANGANA 509325 India |
| Phone |
8250798221 |
| Fax |
04023470444 |
| Email |
samarchatterjeee01@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR Koppineedi Lakshmi Prasanthi |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD 7
Department of Materia Medica
JIMS Homoeopathic Medical College and Hospital Srirama nagar Munchital Hyderabad
Hyderabad TELANGANA 509325 India |
| Phone |
9426909664 |
| Fax |
04023470444 |
| Email |
k.lakshmiprasanthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIMS Homoeopathic Medical College and Hospital Srirama nagar Munchital Telangana 509325 |
|
|
Primary Sponsor
|
| Name |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD 7
Department of Materia Medica
JIMS Homoeopathic Medical College and Hospital Srirama nagar Munchital Telangana 509325 India |
| Type of Sponsor |
Private medical college |
|
|
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 Koppineedi Lakshmi Prasanthi |
JIMS Homoeopathic Medical College and Hospital |
JIMS Homoeopathic Medical College and Hospital Srirama nagar Munchital Hyderabad Hyderabad TELANGANA |
09426909664 04023470444 k.lakshmiprasanthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIMS Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Phyllanthus niruri 6c |
Phyllanthus niruri commonly known as Bhumi Amla has been traditionally used for its hepatoprotective and antioxidant and anti inflammatory properties
Medicine will be prescribed twice daily for one month with further monitoring follow up till 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18 to 60 years
Diagnosed cases of grade 2 fatty liver disease confirmed by ultrasonography |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with grade 1and grade 3 fatty liver disease or cirrhosis of liver
Patients with chronic kidney disease cholecystitis hepatic malignancy or any other
serious systemic illness
Patients who are already on conventional hepatoprotective agents or nephrotoxic drugs
Patients with uncontrolled diabetes mellitus or hypertension
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occurrence of any adverse drug reactions assessed throughout the study period using the ADR Probability scale
Change in liver function test specifically ALT Levels
Change in renal function parameters specifically serum creatinine and urea |
baseline 3rd month and 6th month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in ultrasonographic grading of fatty liver |
baseline 3rd month 6th month |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
15/01/2026 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Fatty liver disease is a prevalent metabolic liver disorder characterized by excessive accumulation of fat within hepatocytes. It is broadly classified into alcoholic fatty liver disease and non-alcoholic fatty liver disease. Grade 2 fatty liver represents a moderate stage of hepatic steatosis, involving 33–66% of hepatocytes, and is clinically significant due to its potential progression to steatohepatitis, fibrosis, cirrhosis, and long-term complications such as hepatocellular carcinoma and cardiovascular disease. Phyllanthus niruri, commonly known as Bhumi Amla, has been traditionally used for its hepatoprotective, antioxidant, and anti-inflammatory properties. In homoeopathic practice, it is known to act predominantly on the hepatobiliary system and is frequently prescribed in liver disorders. However, systematic clinical evidence evaluating the safety and therapeutic response of Phyllanthus niruri in potentised homoeopathic form, particularly in Grade 2 fatty liver disease, remains limited. This prospective, single-arm, open-label interventional study is designed to assess the safety and clinical outcomes of Phyllanthus niruri 6C in patients diagnosed with Grade 2 fatty liver disease of both alcoholic and non-alcoholic etiology. A total of 36 adult participants will be enrolled and administered Phyllanthus niruri 6C twice daily for one month, with follow-up extending up to six months. The primary outcomes focus on safety assessment through continuous monitoring of adverse drug reactions using the ADR Probability (Naranjo) Scale, along with changes in hepatic biochemical parameters, particularly alanine aminotransferase and renal function parameters as serum creatinine and urea. Secondary outcomes include changes in ultrasonographic grading of fatty liver assessed at baseline, third month, and sixth month. Data analysis will be carried out using appropriate statistical methods. Descriptive statistics will summarize baseline characteristics. For normally distributed data, paired t-tests will be applied, while non-parametric data will be analyzed using Wilcoxon signed-rank tests. McNemar’s test will be used for dichotomous outcomes related to adverse drug reactions. This study aims to generate preliminary clinical evidence regarding the safety and potential therapeutic benefits of Phyllanthus niruri 6C in Grade 2 fatty liver disease. |