| CTRI Number |
CTRI/2025/03/082497 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Treatment for fatty liver cases in non alcoholic person |
|
Scientific Title of Study
|
Efficacy Of Individualized Homoeopathic Medicine In Management Of Non Alcoholic Fatty Liver Disease With The Help of Homoeopathic Medical Repertory by Robin Murphy-An Open Interventional Prospective Clinical Study |
| 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 Shweta Verma |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department Of Case Taking And Repertory,State National Homoeopathic Medical College And Hospital, Hahnemann Chauraha,Viraj Khand, Gomtinagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9264927342 |
| Fax |
|
| Email |
sv566573@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sutapa Nandi |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Case Taking And Repertory State National Homoeopathic Medical College And Hospital Hahnemann chauraha, Viraj khand, Gomtinagar ,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
6351407744 |
| Fax |
|
| Email |
drnandisutapa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Verma |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Case Taking And Repertory State National Homoeopathic Medical College And Hospital Hahnemann chauraha, Viraj khand, Gomtinagar ,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9264927342 |
| Fax |
|
| Email |
sv566573@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital viraj khand -1 Gomtinagar Lucknow, Uttar pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Verma |
| Address |
State National Homoeopathic Medical College and Hospital,Viraj Khand-1, Gomti Nagar, Lucknow Uttar pradesh 226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shweta Verma |
State National Homoeopathic Medical College and Hospital |
Department of case taking and Repertory
Viraj Khand-1,Gomti Nagar, Lcknow-226010 o.p.d -05
Lucknow
UTTAR PRADESH |
9264927342
sv566573@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National 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 |
| Intervention |
Homoeopathic Medicines |
Intervention is planned as administrating individualized homoeopathic medicine to a group 30 patient suffering from non alcoholic fatty liver disease after detailed case taking and repertorization. Individualized homoeopathic medicine Will be given in varying potencies depending upon the susceptibility of the patient.Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine (preserved in 90% v/v ethanol) to be taken orally on ab empty stomach. Dosage and repetition will depend upon the individual requirement in each case and the duration of intervention would be 1 year |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Ultrasonographically diagnosed cases of non alcoholic Fatty liver disease.
Non alcoholic patient aged between 20 to 50 years.
Those who have given consent.
Patient of both the sexes will be included. |
|
| ExclusionCriteria |
| Details |
Chronic alcoholic
Patients with history or positive serologic evidence of viral or
autoimmune hepatitis, and Wilson’s disease will be excluded from
this study.
ï‚· Subjects with history of drug intake known to result in liver enzyme
elevation will be excluded. ï‚· Patients with complications of hepatic steatosis like liver cirrhosis, hepatocellular carcinoma.
ï‚· Patients not willing to participate. ï‚· Patient below 20 years and above 50 years of age.
ï‚· Pregnant and lactating women.
ï‚· Patient suffering with any life threatening illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatological assessment |
2 weeks,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in BARD score at baseline & every 3 months of treatment |
12 weeks , 24 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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="1"
Months="6"
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) has a global prevalence of 25%, and is a primary cause of cirrhosis and hepatocellular cancer. NAFLD is a disease spectrum that ranges from steatosis with or without moderate inflammation (non-alcoholic fatty liver) to non-alcoholic steatohepatitis (NASH).The prevalence of the disease has been increased due to the changes of life style(decreased physical activity and alterations in dietary habits) and the increased detection rate. Homeopathy is one of the most popular holistic systems of medicine. The selection of remedy is based upon the theory of individualization and symptoms similarity by using holistic approach. |