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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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