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CTRI Number  CTRI/2019/03/018039 [Registered on: 12/03/2019] Trial Registered Prospectively
Last Modified On: 19/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate the effect of two herbal drugs, bhunimba kshara and katuki churna in combination with restricted diet, exercise and yoga in patients of Non- alcoholic fatty liver disease. 
Scientific Title of Study   A double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba Kshara and Katuki Churna along with lifestyle modifications in the management of Non-Alcoholic Fatty Liver disease(NAFLD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shinsha P 
Designation  MD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kayachikitsa Sixth floor C-Block All India Institute of Ayurveda Gautampuri Mathura road Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone  8851003340  
Fax    
Email  shinshasivadasan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V G Huddar 
Designation  Associate professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kayachikitsa Sixth floor C-Block All India Institute of Ayurveda Gautampuri Mathura road Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  drvghuddar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mangalagowri V Rao 
Designation  Associate professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Swasthavrutha Sixth floor C-Block All India Institute of Ayurveda Gautampuri Mathura road Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone  8178704037  
Fax    
Email  mangowri@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Sarita Vihar, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda Sarita Vihar New Delhi 110076 
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 Shinsha P  New Delhi  All India Institute of Ayurveda Sarita Vihar New Delhi
South
DELHI 		 8851003340

shinshasivadasan@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  
Status 
Not Applicable 
 
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  Bhunimba kshara Capsule 125mg, BD, orally for 1 month Katuki Churna 1g, orally bedtime Lifestyle modifications   Bhunimba Kshara Capsule,125mg two tablets twice daily Orally for 30 days Katuki churna capsule,1g, bedtime, orally, for 30 days. The medicines will be prepared according to the instructions of AFI. Lifestyle modifications in the form of diet exercise and yoga will be advised.  
Comparator Agent  Placebo capsule Lifestyle modifications  Two Placebo Capsules filled with godhuma churna separated by two different colors, orally for 30 days Lifestyle modifictions in the form of diet exercise and yoga  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Non-alcoholic fatty liver disease patient who diagnosed by abdomen ultrasonic examination and Non-drinker Or total abstainer or with alcohol intake of less than 20g per day for female and less than 30 g per day for males
NAFLD confirmed by USG with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen
3. Voluntary agreement and enrolment. 
 
ExclusionCriteria 
Details  The ratio of AST and ALT over 2
Metabolic syndromes such as Type I and II diabetes mellitus hypertension
Thyroid dysfunctions hypothyroidism or hyperthyroidism
Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient
Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months
Patient taking any product which affects the BMI or hyperlipidemia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in the infiltration of fat globules in Ultrasonography (USG) findings along with changes in clinical presentations  Zero
Thirteith day 
 
Secondary Outcome  
Outcome  TimePoints 
Liver function tests
Lipid profile
Changes in body weight, BMI and waist hip ratio
Relief of the following symptoms like Fatigue, Pain in epigastrium, Anorexia, Nausea
Overall improvement in quality of life 		 Zero
Thirty 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/04/2019 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The thesis study will be published in reputed journals 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba kshara capsule, 125mg twice daily and katuki churna 1g bedtime along with modification of  lifestyle for a period of one month in the patients of Non alcoholic liver diseases. Over the past couple of decades, it has become increasingly clear that non alcoholic fatty liver disease (NAFLD) and non-alcoholic steato-hepatitis (NASH) are the significant causes of liver disease. NAFLD also called as hepatic steatosis is a manifestation of excessive triglycerides accumulation in the liver. Improper diet, lack of exercise and unhealthy lifestyle are the leading cause of this. The aim of the study to evaluate the efficacy of bhunimba kshara and katuki churna for reversing the fatty degeneration and preventing the progression of the condition to further complications like hepato cellular carcinoma and liver cirrhosis etc. The primary outcome measures the changes in the fatty degeneration of hepatic cells which will be assessed by using  ultrasonography. The secondary outcome is that the intervention will help to normalize the liver function tests and cure of the symptoms in NAFLD patients. Placebo drugs will be given the control group along with the modification of lifestyle. The subjects for the study will be selected from the OPD and IPD of All India Institute of Ayurveda , New Delhi and the follow up should be done on zero, fifteenth, thirteith and sixteith day of patient enrollement.   
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