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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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