| CTRI Number |
CTRI/2022/07/044256 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Phyllantus niruri mother tincture in non alcoholic fatty liver disease |
|
Scientific Title of Study
|
An exploratory single arm clinical trial assessing the effectiveness of Phyllantus niruri mother tincture in non alcoholic fatty liver diseasein Muzaffarpur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit |
| Designation |
Lecturer Department of Repertory |
| Affiliation |
R.B.T.S Govt. Homeopathic Medical College and Hospital |
| Address |
R.B.T.S Govt. Homeopathic Medical College and Hospital, Ramdayalunagar, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit |
| Designation |
Lecturer Department of Repertory |
| Affiliation |
R.B.T.S Govt. Homeopathic Medical College and Hospital |
| Address |
R.B.T.S Govt. Homeopathic Medical College and Hospital, Ramdayalunagar, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit |
| Designation |
Lecturer Department of Repertory |
| Affiliation |
R.B.T.S Govt. Homeopathic Medical College and Hospital |
| Address |
R.B.T.S Govt. Homeopathic Medical College and Hospital, Ramdayalunagar, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic Medical college and Hospital Muzaffarpur |
|
|
Primary Sponsor
|
| Name |
Dr Amit |
| Address |
RBTS Govt Homoeopathic Medical college and Hospital |
| 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 Amit |
RBTS Govt Homoeopathic Medical college and Hospital |
Department of Repertory, P.G Block, Ramdayalunagar
Muzaffarpur
BIHAR |
7765802619
amitrisdth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Phyllanthus niruri |
10 drops in ½ cup of water twice daily after meals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-60 years ii. Self reported cases of non-alcoholic fatty liver disease. iii. Patients with type 2 diabetes mellitus and dyslipidemia. iv. Patients with BMI more than 25kg/m2.
v. Patients having Alanine aminotransferase (ALT) >40 U/L and Aspartate aminotransferase (AST)/ALT ratio >0.8 to < 1. vi. Ultrasound abdomen showing fatty liver. vii. Non alcoholics or consumption of less than 20 gm and 30 gm of alcohol per day in women and men respectively. viii. Both sexes. ix. Patients volunteering |
|
| ExclusionCriteria |
| Details |
Patients unwilling to take part or not giving consent to join the study. ii. Diagnosed cases of systemic diseases, psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure. iii. Known cases of endocrine disorders including Cushing’s syndrome or history of long term steroid intake or any other secondary causes of fatty liver. iv. Pregnancy and lactation. v. Substance abuse and/ or dependence. vi. Self reported immune-compromised state. vii. Undergoing homoeopathic treatment for any chronic disease within the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of fatty liver on USG abdomen. ii. Improvement in liver enzymes (AST, ALT). |
All the outcome measures will be assessed at Baseline (0 month) and after 3 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
36-Item Short-Form Health Survey (SF-36). ii. Change in body mass index.
|
All the outcome measures will be assessed at Baseline (0 month) and after 3 months.
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
27/07/2022 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
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 is a worldwide issue and one of the most prevapent liver illness. The increase prevalence and risk of progression of disease demands therapeutic attention. With this intension, we plan to assess the effectiveness of phyllanthus niruri Mother tincture in patients with non alcoholic fatty liver disease. |