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CTRI Number  CTRI/2024/05/067829 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 21/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to assess the effects of Homoeopathic medicines in patients with non alcoholic fatty liver disease 
Scientific Title of Study   Efficacy Of Individualized Homoeopathic Medicines In The Management Of Non Alcoholic Fatty Liver Disease: A Prospective Randomized Single Blind Placebo Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRajesh Kumar Verma  
Designation  Professor 
Affiliation  Pt JLN State Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic Materia medica Ground Floor Pt JLN State Homoeopathic Medical College and Hospital Lakhanpur Kanpur 208024

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9918877844  
Fax    
Email  pjlnrhmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRajesh Kumar Verma  
Designation  Professor 
Affiliation  Pt JLN State Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic materia medica Ground floor Pt JLN State Homoeopathic Medical College and Hospital Lakhanpur Kanpur 208024


UTTAR PRADESH
208024
India 
Phone  9918877844  
Fax    
Email  pjlnrhmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRajesh Kumar Verma  
Designation  Professor 
Affiliation  Pt JLN State Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic materia medica Ground floor Pt JLN State Homoeopathic Medical College and Hospital Lakhanpur Kanpur 208024


UTTAR PRADESH
208024
India 
Phone  9918877844  
Fax    
Email  pjlnrhmc@gmail.com  
 
Source of Monetary or Material Support  
Government of Uttar Pradesh Ayush Anubhag 2 Uttar Pradesh Shashan Lal bahadur Shastri Bhavan Lal Bagh Lucknow 226001 
 
Primary Sponsor  
Name  Government of Uttar Pradesh 
Address  Government of Uttar Pradesh Ayush Anubhag 2 Uttar Pradesh Shashan Lal bahadur Shastri Bhavan Lal Bagh Lucknow UP 226001 
Type of Sponsor  Government funding agency 
 
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 Rajesh Kumar Verma  Collegiate Hospital of Pt Jawahar Lal Nehru State Homoeopathic Medical College and Hospital   OPD 1 to7, Collegiate Hospital of Pt Jawahar Lal Nehru State Homoeopathic Medical College and Hospital Lakhanpur Kanpur Uttar Pradesh 208024
Kanpur Nagar
UTTAR PRADESH 
9918877844

pjlnrhmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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 
Intervention  Individualized Homoeopathic Medicines with Life style modification  Individualized Homoeopathic Medicines will be procured from a GMP certified company Potency Potency will be selected according to patient susceptibility based on homoeopathic principles Route of Administration Oral route of administration in globules Doses Each dose will consist of 4 globules Number30 moistened with indicated medicine Repetition Repetition will be According to patient susceptibility and homoeopathic principles Dispensing will be done by Certified Pharmacist of Pt Jawahar Lal Nehru State Homoeopathic Medical College & Hospital Lakhanpur Kanpur Total duration of intervention will be atleast one year  
Comparator Agent  Placebo with Life Style modification  PLACEBO identical in appearance to verum will be procured from a GMP certified company Route of Administration Oral route of administration in globules Doses Each dose will consist of 4 globules Number30 moistened with 90 percent v/v ethanol Repetition Repetition will be According to patient susceptibility and homoeopathic principles Dispensing will be done by Certified Pharmacist of Pt Jawahar Lal Nehru State Homoeopathic Medical College & Hospital Lakhanpur Kanpur Total duration of intervention will be atleast one year  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Individuals with Grade I to III NAFLD established by Ultrasonography and or ALT enzymes level more than 30 IU per mL in males and more than 19 IU per mL in females
Clinically diagnosed cases of Fatty Liver
Patients willing to give consent either
 
 
ExclusionCriteria 
Details  Pregnant females and lactating mothers will be excluded
Individuals not providing written informed consent for the study
Patient with existing from liver diseases like Alcoholic Fatty Liver Grade IV Non Alcoholic fatty Liver disease viral hepatitis Autoimmune liver diseases hepatocellular carcinoma
Patient with Uncontrolled Diabetes Uncontrolled Hypertension renal or cardiac disease stroke or any other serious systemic illness
Patient on any other medication
Patient with medical emergencies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant changes in the scores of Chronic Liver Disease Questionnaire for NAFLD/NASH(CLDQ NAFLD/NASH )   At Baseline 4th month 8th month 12th month  
 
Secondary Outcome  
Outcome  TimePoints 
Serum ALT level  At Baseline 4th month 8th month 12th month  
Significant changes in BARD Score   At Baseline 4th month 8th month 12th month  
 
Target Sample Size   Total Sample Size="354"
Sample Size from India="354" 
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/ Phase 3 
Date of First Enrollment (India)   01/07/2024 
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="3"
Months="0"
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  

Non Alcoholic Fatty Liver Disease (NAFLD) is characterized by the presence of macro-vesicular steatosis in at least 5% of hepatocytes, without any secondary causes like alcohol or drug use. This condition includes a range of disease states, starting from non-alcoholic fatty liver (NAFL) and progressing through non-alcoholic steato-hepatitis (NASH), fibrosis, and ultimately cirrhosis. NAFLD stands out as a prominent liver disease globally, with an estimated global incidence of 47 cases per 1,000 population. This incidence is higher among males than females. The prevalence of NAFLD in India accounts for about 9-32% of general population.. Homoeopathic medicines improves the overall biological processes and reinstates the homoeostasis needed for the efficient functioning of the organ.

NAFLD being a life style disorder is becoming prevalent and managing NAFLD involves making sustainable lifestyle changes that promote a healthy weight, balanced nutrition, and overall well-being. A holistic approach encompassing dietary modifications, physical activity, and stress management along with homoeopathic treatment is critical to reducing the risk of NAFLD and its associated complications. Previous studies conducted on managing NAFLD  with homoeopathy are  few in number and mostly based on specific medicines with organ affinities. This study is an attempt to prove to be a landmark in assessing the role of Individualized homoeopathic medicine in the management of NAFLD along with Lifestyle modification . A  single blind randomized placebo controlled  (1:1) trial will be conducted on  354 adults  who are suffering from  NAFLD at OPD of  Pt. JLN Homoeopathic Medical College and Hospital . Primary outcome assessment  will be done by evaluating the  significant difference in CLDQ -NAFLD/NASH   questionnaire after  12 months. Secondary Outcome assessment will be done by evaluating Serum ALT  levels    and Changes in BARD score after 12 months of  Baseline Intervention . Group differences will be analyzed  statistically . Result will be published in  peer reviewed  scientific journal . 

 
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