| CTRI Number |
CTRI/2025/02/080058 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of non-alcoholic fatty liver disease. |
|
Scientific Title of Study
|
Role of Vanadium metallicum 30c in the treatment of non-alcoholic fatty liver disease. |
| 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 Deepali Sharma |
| Designation |
Post Graduate Resident |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Materia Medica,State National Homoeopathic Medical College and Hospital Lucknow,1-Viraj Khand,Gomti Nagar,Lucknow,Uttar Pradesh 226010, India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7906019256 |
| Fax |
|
| Email |
deepalisharma23oct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Sharma |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Practice of Medicine,State National Homoeopathic Medical College and Hospital,Lucknow,1-Viraj Khand,Gomti Nagar,Lucknow,Uttar Pradesh 226010,India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8418828842 |
| Fax |
|
| Email |
drnutansharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Sharma |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Practice of Medicine,State National Homoeopathic Medical College and Hospital,Lucknow,1-Viraj Khand,Gomti Nagar,Lucknow,Uttar Pradesh 226010,India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8418828842 |
| Fax |
|
| Email |
drnutansharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital,Lucknow,1-Viraj Khand,Gomti Nagar,Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Deepali Sharma |
| Address |
Department of Materia Medica,State National Homoeopathic Medical College and Hospital,Lucknow,1-Viraj Khand,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 |
| Dr Deepali Sharma |
State National Homoeopathic Medical College and Hospital,Lucknow |
Department of materia medica,Gomti Nagar,Lucknow,Uttar Pradesh-226010
Lucknow
UTTAR PRADESH |
7906019256
deepalisharma23oct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital Lucknow |
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 medicine Vanadium metallicum 30c |
30c potency will be given to the patients and dose and its repeatation will be done as per the requirement of the case and severity of the disease.Route of administration-oral.In addition to this,placebo will be given to the patients till final assessment of the case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 20 to 65 years.
2.Both sexes are included.
3.Patients with any grade of fatty liver(1st grade,2nd grade,3rd grade)
4.Patients who are in regular follow up. |
|
| ExclusionCriteria |
| Details |
1.Clinical or histologic evidence of alcoholic liver disease.
2.Patients with any other complicated disease of liver(Carcinoma etc).
3.Patients with any systemic disease like renal failure,hepatocellular carcinoma,valvular heart disease etc.
4.Patients with hepatotoxic liver due to prolonged medication.
5.Pregnant and lactating females with fatty liver.
6.Any patients who have gone through any gastric surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in USG findings before and after treatment. |
3 to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of vanadium metallicum 30c by using BARD score rating scale. |
3 to 6 months |
|
|
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)
|
16/02/2025 |
| 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) is one of the most common liver disorders globally,affecting individuals who do not consume alcohol in amounts considered harmful.This is an open level prospective clinical study to find out the role of vanadium metallicum 30c in the treatment of non-alcoholic fatty liver disease.Doses will be selected as per the requirement of the individualised case. Patients will be called up for follow up after 15 days interval or as per the requirement of the case.Outcome will be measured with the help of USG and change in BARD score rating scale before and after the treatment. |