| CTRI Number |
CTRI/2024/09/074404 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effectiveness of personalized homeopathic treatments for non alcoholic fatty liver disease A study comparing homoeopathic treatment with placebo. |
|
Scientific Title of Study
|
Efficacy of Individualized Homeopathic medicines in Non Alcoholic Fatty Liver Disease A Randomized Placebo Controlled Clinical 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 |
Dr Labeeba Ali K |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College, Karaparamba Kozhikode |
| Address |
Department of Materia medica, Government Homoeopathic Medical College, Karaparamba
Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
8714271110 |
| Fax |
|
| Email |
alilabeeba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thara K |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College, Karaparamba Kozhikode |
| Address |
Department of Materia medica, Government Homoeopathic Medical College, Karaparamba
Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9745245755 |
| Fax |
|
| Email |
drthararaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thara K |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College, Karaparamba Kozhikode |
| Address |
Department of Materia medica, Government Homoeopathic Medical College, Karaparamba
Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9745245755 |
| Fax |
|
| Email |
drthararaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical college,Karaparamba, Kozhikode, Kerala, India
673010(pin code) |
|
|
Primary Sponsor
|
| Name |
Dr Labeeba Ali K |
| Address |
Post Graduate Scholar Department of Materia medica
Government Homoeopathic Medical College
Kozhikode |
| 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 Labeeba Ali K |
Government homoeopathic medical college Kozhikode |
Research OP
Department op
Government homoeopathic medical college
Karaparamba
673010
Kozhikode
KERALA |
8714271110
alilabeeba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College , Kozhikode, Kerala. |
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 |
Constitutional Homoeopathic
medicines |
After assessing the totality of symptoms of each patient,
consider the most suitable
homoeopathic medicinal
potency.Potency and repetition of medicine can be changed in the follow ups, according to the demand of the case.Duration of intervention 15 weeks. |
| Comparator Agent |
Placebo |
Placebo will be dispensed in
the powder and tablet form and it will be identical to the homoeopathic medicine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases with elevated liver enzymes ALT or AST.
2. Ultrasonography abdomen findings with grade 1& grade 2 fatty liver.
3.Non Alcoholic Male and Female Patients aged between 18-60years.
4. Individuals with present or past history of alcohol consumption in an amount less than a
particular level aged between 18-60 years(20 gm/day for males and 10 gm/day for females)
of alcohol will be included |
|
| ExclusionCriteria |
| Details |
1. Adults who had a heart attack or stroke, or other atherosclerotic disease.
2. Patients diagnosed with diabetics (glycosylated hemoglobin above 6.5%.)
3. Patients diagnosed with moderate and severe hypertension (BP 160/100 mmHg above)
4. Patients with HBsAg positive.
5. Patients with complications of hepatic steatosis like liver cirrhosis, hepatocellular
carcinoma.
6. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of individualized homoeopathic medicines relative to a placebo in
modifying blood ALT and AST levels and grading of fatty liver in ultrasonography findings in
patients with NAFLDs after 15 weeks of study. |
Each case will be reviewed at 3 weeks interval and followed for a period of minimum 15 weeks.
Serum ALT and AST value estimation will be done at an interval of 3 weeks or whenever
necessary.
Risk for fibrosis will be assessed by calculating fibrosis score FIB-4 index.
USG Abdomen will be done at baseline and at final outcome period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
determine the change in ‘risk for fibrosis’ in patients before and after treatment by FIB-4
index. |
Changes in the risk for fibrosis will be accessed by FIB-4 index at baseline &15 weeks after
treatment. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
06/10/2024 |
| 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="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
|
This study is for the clinical evaluation of individualized homoeopathic medicine in the treatment of non alcoholic fatty liver diseases. study conducted in two groups. One group will be provided with homoeopathic medicine and other will be provided with identical placebo. Each case will be reviewed at 3 weeks for a period of minimum 15 weeks. Serum ALT and ALT estimation will be done at an interval of 3 weeks. Risk for fibrosis will be assessed by FIB4 index. USG abdomen will be done at baseline and at final outcome of study. |