CTRI Number |
CTRI/2021/10/037692 [Registered on: 29/10/2021] Trial Registered Prospectively |
Last Modified On: |
28/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A Randomized controlled trial of Kalmegh on
Non Alcoholic Fatty Liver Disease. |
Scientific Title of Study
|
A Randomized Controlled Trial of Kalmegh on
Non Alcoholic Fatty Liver Disease. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sunil kumar |
Designation |
Associate professor |
Affiliation |
Associate Professor, Department of community medicine IMS BHU Varanasi |
Address |
Department of Community Medicine Institute of Medical Sciences Banaras Hindu University Varanasi. Institute of Medical Sciences Banaras Hindu University Varanasi 221005 Varanasi UTTAR PRADESH 221005 India |
Phone |
9450808948 |
Fax |
|
Email |
sunilk.cmed@bhu.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sunil kumar |
Designation |
Associate professor |
Affiliation |
Department of community medicine IMS BHU Varanasi |
Address |
Department of community medicine Institute of Medical Sciences Banaras Hindu University Varanasi. Department of community medicine Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi UTTAR PRADESH 221005 India |
Phone |
9450808948 |
Fax |
|
Email |
sunilk.cmed@bhu.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Sanket Vilas Nandekar |
Designation |
Junior resident |
Affiliation |
Department of community medicine IMS BHU Varanasi |
Address |
Department of community medicine Institute of Medical Sciences Banaras Hindu University Varanasi Department of community medicine Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi UTTAR PRADESH 221005 India |
Phone |
7588779807 |
Fax |
|
Email |
sanket31081994@gmail.com |
|
Source of Monetary or Material Support
|
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI |
|
Primary Sponsor
|
Name |
Department of community medicine INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY |
Address |
IMS BHU Varanasi 221005 |
Type of Sponsor |
Research institution and hospital |
|
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 Sanket Vilas Nandekar |
Sir Sunderlal Hospital, Institute Of Medical sciences BHU |
Gastroenterology opd, Department of Gastroenterology, Sir Sunderlal Hospital, Institute Of Medical sciences BHU Varanasi 221005 Varanasi UTTAR PRADESH |
7588779807
sanket31081994@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E65||Localized adiposity. Ayurveda Condition: Yaká¹›t Roga (liver disease) and Medoroga (obesity)., |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
KALMEGH -Ayurvedic preparation
|
1/2 to 1ml, twice a day before meal in the form of Ghanvati for 6 months.
|
Comparator Agent |
PLACEBO |
Will look like intervention but without any drug in it. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patient giving consent to participate in the study.
2..Adult Population of age group 18-60yrs attending Gastroenterology OPD
3.Patient with simple fatty liver
Patient with Non-Alcoholic SteatoHepatitis.
4.Patient with Non-Alcoholic SteatoHepatitis and fibrosis of STAGE -I and STAGE-II
|
|
ExclusionCriteria |
Details |
1.Patient having Diabetes Mellitus.
2.Patient with alcoholic addiction.
3.Patient with NASH and fibrosis of STAGE-3.
4.Patient with liver cirrhosis.
5.Patient with severe obesity.
6.Patient not giving consent to participate in the study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Outcome assessment for effectiveness of kalmegh will be done on the basis of prepared proforma and improvement in patients with NAFLD on the basis of fibro scan and USG liver reports of the NAFLD patients after 6 months of treatment. Also to assess the agreement of noninvasive methods, like LFT and liver USG with Fibro scan liver. |
Total 3 follow ups will be done, first after 1 month of treatment, second after 3 months of treatment, third after 6 month of treatment to see the changes in the parameters of investigation reports. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate the cost of one-month treatment of Kalmegh for treatment NAFLD. |
Total 3 follow ups will be done, first after 1 month of treatment, second after 3 months of treatment, third after 6 month of treatment to see the changes in the parameters of investigation reports. |
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
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)
|
16/11/2021 |
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
|
Not published 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 (NAFLD) is a multifactorial disease and the most common of chronic liver diseases worldwide. NAFLD is present in ~32% of general population in India and its prevalence is rising remarkably, in parallel to that of obesity, especially in developing countries such as India. The global prevalence of NAFLD is estimated to be 25%, with the lowest prevalence in Africa (13.5%) and highest in the Middle East (31.8%) and South America (30.4%). Non-alcoholic fatty liver disease (NAFLD), is recognized as a health care burden worldwide. The rapidly rising healthcare and economic burdens of NAFLD warrant institution of preventative and treatment measures in the high-risk sub-populations in an effort to reduce the morbidity and mortality associated with NAFLD. For the purpose of present clinical study Kalmegh is selected as a trial drug for comprehensive clinical trial in NAFLD. There will be two groups of study subjects for the trial, control group and experimental group. Control group will receive the standard treatment i.e. dietary advice and exercise. Experimental group will receive the drug intervention apart from advice on diet and exercise. Drug Intervention is Kalmegh (Andrographis Paniculata Nees) 1/2 to 1ml, twice a day before meal in the form of Ghanvati for 6 months. Study participants and data analyzer will be blinded regarding the allocation of the group. Total 3 follow ups will be done, first after 1 month of treatment, second after 3 months of treatment, third after 6 month of treatment to see the changes in the parameters of investigation reports. Outcome assessment for effectiveness of kalmegh will be done on the basis of prepared proforma and improvement in patients with NAFLD on the basis of fibro scan and USG liver reports of the NAFLD patients after 6 months of treatment.
|