| CTRI Number |
CTRI/2025/01/079075 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Homoeopathic Medicines In The Treatment Of Non-alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicines In The Treatment Of Non-alcoholic Fatty Liver Disease:A Prospective Single-arm 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 Ancy Saj |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical college and Hospital, B block Defence colony,New Delhi
South
DELHI
110024
India |
| Phone |
8078192147 |
| Fax |
|
| Email |
ancysaj1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Thakkar |
| Designation |
HOD(Practice of Medicine) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical college and Hospital, B block Defence colony,New Delhi
South
DELHI
110024
India |
| Phone |
8851006347 |
| Fax |
|
| Email |
rakeshthakkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ancy Saj |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical college and Hospital, B block Defence colony,New Delhi
South
DELHI
110024
India |
| Phone |
8078192157 |
| Fax |
|
| Email |
ancysaj1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no:11,Out patient Department of Nehru Homoeopathic Medical College and Hospital,Defence Colony,B block New Delhi,India,110024 |
|
|
Primary Sponsor
|
| Name |
Dr Ancy Saj |
| Address |
Nehru Homoeopathic Medical College and Hospital,B-Block, Defence colony,New Delhi-
110024 |
| 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 Ancy Saj |
Nehru Homoeopathic Medical College and Hospital |
Room no:11, Nehru
Homoeopathic Medical
College and Hospital, B-
Block, Defence colony,
New Delhi-110024
South
DELHI |
8078192147
ancysaj1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee of Nehru 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 |
Administration of Individualized Homoeopathic Medicine |
Following obtaining consent and screening using specified selection (inclusion and exclusion) criteria, 30 eligible patients will be included in the trial. Following that patient will be planned to receive individualized homoeopathic remedy. Individualized dose will be selected on the judgement of susceptibility of the patients. Subsequent prescription will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. All medicine procured from good manufacturing practice(GMP) certified pharmacies.Selection of potency, dosage and mode of administration- based upon the severity of symptoms, susceptibility of the patient, miasmatic background. mode of administration will be oral. Depending upon the severity of symptoms, reaction of patient and susceptibility of patient, repetition of remedy will be done. follow up will depend upon the necessity and severity of the case. preferably once every week for a month and then after 15 days. The study is conducting for 1 year duration |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Non-Alcoholic patients
2.Both male and female patients aged between
18-70 years.
3.Patients with elevated Serum ALT
4.Patients with elevated serum AST
5.Ultrasonographically diagnosed cases of
NAFLD.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with history of drug intake known
to result in liver enzyme elevation
2.Patients with complications of like liver
cirrhosis, hepatocellular carcinoma.
3.Patients with cholelithiasis &
cholecystitis.
4 Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum ALT and serum AST level |
At baseline and at an interval of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparing changes in Ultrasonography of Abdomen
|
6 months
|
| Improvement in quality of life (WHO-QOL bref scale ) |
At baseline and at the end of study |
| BARD SCORE |
3 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)
|
03/02/2025 |
| 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="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
|
A prospective single-arm study to know the effectiveness of individualized homoeopathic medicines in Non-alcoholic fatty liver disease OBJECTIVES- Primary Objective: 1. To assess the effectiveness of individualized Homoeopathic medicines in the treatment of NAFLD by evaluating change in serum ALT and serum AST Secondary objective 1. To find out the changes in grade level of NAFLD in ultrasonography after Homoeopathic medicines 2. To determine the changes in Quality of Life WHO Quality of Life Scale-Brief in patients with NAFLD after homoeopathic intervention. 3. To find out changes in BARD Score in patients with NAFLD to predict risk of advanced fibrosis
• DIAGNOSTIC CRITERIA • Liver function test • Ultra sonogram(USG)of abdomen
• Procurement of medicines: Pharmacy of Nehru Homoeopathic Medical College and Hospital. If not available it will be provide from a GMP certified pharmacy • Study duration: maximum 12 months • Study design: Prospective open label single-arm clinical study. • Sample size- Minimum 30 cases
|