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CTRI Number  CTRI/2017/06/008941 [Registered on: 29/06/2017] Trial Registered Prospectively
Last Modified On: 29/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to assess an ayurveda treatment protocol combined with diet life style regimen in the reversal of non alcoholic fatty liver disease. 
Scientific Title of Study   ‘A randomized controlled clinical trial to assess the comparative efficacy of ayurveda treatment protocol and diet-lifestyle regimen in the reversal of first grade 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  Vandana RaniM 
Designation  Professor 
Affiliation  Amrita school of ayurveda 
Address  Department of swasthavritta Amrita school of ayurveda Clappana P.O, Karunagappally

Thiruvananthapuram
KERALA
690525
India 
Phone  9446441441  
Fax    
Email  vandanarani72@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vandana RaniM 
Designation  Professor 
Affiliation  Amrita school of ayurveda 
Address  Department of swasthavritta Amrita school of ayurveda Clappana P.O, Karunagappally

Thiruvananthapuram
KERALA
690525
India 
Phone  9446441441  
Fax    
Email  vandanarani72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vandana RaniM 
Designation  Professor 
Affiliation  Amrita school of ayurveda 
Address  Department of swasthavritta Amrita school of ayurveda Clappana P.O, Karunagappally

Thiruvananthapuram
KERALA
690525
India 
Phone  9446441441  
Fax    
Email  vandanarani72@gmail.com  
 
Source of Monetary or Material Support  
Amrita school of ayurveda Clappana P.O, Karunagappally Kollam-690525 
 
Primary Sponsor  
Name  Amrita School of Ayurveda 
Address  Vallikkavu, Clappana PO,Karunagapally,Kollam 
Type of Sponsor  Private medical college 
 
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 Vandana Rani M  Amrita ayurveda hospital  Vallikkavu, Clappana PO,Karunagapally,Kollam,Kerala
Kollam
KERALA 
9446441441

vandanarani72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita Institute of Heath Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Apparently healthy people who are not taking allopathic medicines for any chronic diseases of 20-55years of both sexes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator Agent - Group for whom Ayurveda Diet and Exercise shall be prescribed .  Comparator Agent- Group will be given Ayurveda diet and exercise. 
Intervention  Intervention Group - for whom Ayurveda Diet , Exercise and Ayurveda treatment protocol shall be prescribed. Comparator Agent - Group for whom Ayurveda Diet and Exercise shall be prescribed .  Intervention Group- Group protocol will be exercised along with Ayurveda diet and exercise Comparator Agent- Group will be given Ayurveda diet and exercise. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  People of age in b/w 20-55yrs of both sex.
Apparently healthy people who are not taking allopathic medicines for any chronic diseases.
 
 
ExclusionCriteria 
Details  People below 20 yrs and above 55yrs.
Alcoholics
Other liver disorders like Viral hepatitis, Hepatitis C etc.
Type 2 Diabetes
Pregnancy
Other chronic diseases.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Blood lipid profile, Liver Function Test will get improve
 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
US Abdomen- Normal liver scan  3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   27/07/2017 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Non alcoholic Fatty Liver Syndrome (NAFLD) is now regarded as the hepatic manifestation of metabolic syndrome. Three lifestyle diseases i.e.  Diabetes, obesity and hyperlipidemia  are considered as risk factors. 70% Non-alcoholic Steatohepatitis   had one or more of the above risk factors. Prevalence of NAFLD in asymptomatic middle-aged patients is as high as 46.0%.  When they continue  the same life style it will lead to fatty liver infiltration and then to  liver cirrhosis or even liver cancer. So an early intervention that reverses the pathology might decrease the morbidity and mortality rate. Current treatment focuses on decreasing insulin resistance, Cholesterol management and Weight loss.  Studies on drugs like metformin, thiazolidinediones prescribed for NAFLD are found to have significant side effects. Bariatric surgery has been proved as effective but is expensive. Studies on first-line treatment approach to NAFLD based on diet and lifestyle modification are nonrandomized and short term. Due to paucity of data it is difficult to produce evidence-based recommendations about dietary modifications and exercise in NAFLD patients. Moreover, dietary treatment alone is limited by the lack of compliance and the frequent regain of weight at follow-up. So an Ayurveda treatment protocol that is safe and inexpensive, effective in the reversal of first grade fatty liver is the need of the hour.

Subjects who meet inclusion criteria and are willing to participate in the study will be assigned into two groups of 50 each according to Simple Random Sampling method. They are 1) Control Group:- for whom Ayurveda Diet and Exercise  shall be prescribed and 2) Trial Group:- for whom  Ayurveda Diet , Exercise and Ayurveda medicine shall be prescribed . At baseline all study subjects will be screened for blood lipid profile, LFT, and US abdomen to confirm diagnosis. For the Control Group Diet preparations wholesome diet suitable for diabetes ,obesityand dyslipedemia shall be given. Exercise regimen shall be according to their BMI, Occupation, Constitution , Season and Strength. For the Trial Group apart from Ayurveda Diet and exercise, treatment aiming at  treatment for reducing fat, increasing digestive power, that increases digestion and due regulation of dosha followed by hepato protective Rasayana  will be prescribed. Each group shall be constantly monitored separately for three months. Blood tests done at base line will be repeated in participants who successfully complete the treatment within the prescribed time. Pre test post comparison of the quantitative variables will be analysed by paired t test or Wilcoxon signed rank test according to the nature of the data. Pre test post test comparison of qualitative variables will be analysed by McNemar test. Between groups differences of the quantitative variables will be evaluated by independent sample test. A p-value of <0.05 will be considered as the level of significant. Data analysis will be performed using SPSS ver 17.0. 

 
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