| 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
|
|
|
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
|
|
|
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 . |