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CTRI Number  CTRI/2023/08/055977 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to evaluate the efficacy of Parikara Yoga (An Ayurvedic polyherbal formulation) and Dietary regimen in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD) 
Scientific Title of Study   A Randomized placebo controlled trial to evaluate the efficacy Of Parikara Yoga and Pathya in the Management of Yakrita Roga with special reference to Non-Alcoholic Fatty Liver Disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Km. Neeraj 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9627933350  
Fax    
Email  neeruverma934@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Kumar Garg 
Designation  Assistant Professor 
Affiliation  National Institute Of Ayurveda ,Deemed to be University, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  7988890284  
Fax    
Email  gauravdrgarg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Kumar Garg 
Designation  Assistant Professor 
Affiliation  National Institute Of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur Jaipur RAJASTHAN 302002 India
Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  7988890284  
Fax    
Email  gauravdrgarg@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed to be University, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda Deemed to be University, Jaipur 
Address  Near Jorawor Singh gate, Amer Road, Jaipur, Rajasthan- 302002 
Type of Sponsor  Government 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 Km Neeraj  Hospital, National Institute of Ayurveda, Jaipur  OPD No. 1, 7, 22, 25, Hospital, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur, Rajasthan 302002 Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 9627933350

neeruverma934@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of National Institute of Ayurveda, Jaipu  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. Ayurveda Condition: Yakrita Roga, (2) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. Ayurveda Condition: YAKRUDDALYUDARAH, (3) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Parikara yoga, Reference: Chakradatta 38/15-17, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Usnodaka), Additional Information: -
2Intervention ArmLifestyle--Dinacarya: Early wakeup, Ritucarya: NA, Acara Rasayana:NA, Other:NA, Pathya/Apathya:yes, Pathya:• Timely meals. • Eat only when feel hungry. • Take light food. • Drink water only when you feel thirsty and drink about 150ml in one time. • Use of Go-Ghrita. • Always eat fresh food. • Use of Saindha namak. • Sesame oil or mustard oil should be used for cooking purpose. • 2- 3 hrs difference should be present in between eating and sleeping. • Advised Vegetables -Bottle Gourd, Drumstick, Pointed Gourd, Ridged Gourd, Sponge Gourd, Spinach, Bitter Gourd, Indian Ro, Apathya:• Avoid Oily Food. • Avoid excessive eating. • Avoid Fast food like pizza,burger,momos,samosas,kachori • Avoid frequent eating • Avoid excessive use of dairy products, sweets. • Don’t hold Natural Urges. • Avoid Day Time Sleep. • Avoid Alcohol,Smoking,Tobacco Chewing,hukka etc. • Avoid drinking cold water. • Avoid eating foods which are refrigerated. • Avoid eating Meat,Egg,Fish on daily basis. • Avoid vegetables like Potato,Cauliflower,Beans, Black l
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1. Patients of either sex of age group >18years and <60 years with USG
finding suggestive of fatty liver grade 1,2 and 3.
2.Non-Alcoholic or patients with history of alcohol addiction less than 20gm
per day in men and 10 gm per day in women.
3. Clinical sign and symptoms suggesting of Yakrita Roga/NAFLD that is,
pain in right upper quadrant/ epigastric region of abdomen, feeling of nausea,
heaviness in abdomen, flatulence ,loss of appetite and burning sensation in
abdomen if any.
4. Patients with normal serum bilirubin level and ALT/AST level less than 1.5
times of normal limit.
5. Patients with/without raised lipid profile. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women.
2. Patients with history of diabetes mellitus, autoimmune hepatitis, drug
abuse, chronic Hepatitis, raised ALT/AST level more than 1.5 times of
normal limit.
3. Patients with complications of metabolic syndrome such as
cerebrovascular accident, myocardial infarction, chronic kidney diseases,
suffering from cirrhosis, ascites, variceal haemorrhage, coagulopathy,
hepatorenal syndrome
4. Patient have any kind of malignancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in USG findings and grading at the end of 56 days  Changes in USG findings and grading at the end of 56 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in liver function test, lipid profile at the and of 56 days
2. Changes in clinical sign and symptoms if any at the end of 60 days 		 At the end of 56 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/08/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Over the past few decades Non-alcoholic fatty liver disease (NAFLD) is most common chronic liver disease in most part of the world it encompasses a spectrum of liver pathology with different clinical progress due to accumulation of triglycerides in hepatic cells. Non-alcoholic fatty liver disease (NAFLD) is independent risk factor for metabolic syndrome and is associated with various metabolic risk factors including insulin resistance, dyslipidaemia, cardio-vascular disease, and most significantly obesity. Non-alcoholic fatty liver disease can remain harmless but, in some people, it may progress to non-alcoholic steatohepatitis (NASH). Non-alcoholic steatohepatitis is the progressive stage of Non-alcoholic fatty liver disease. i When NAFLD progress to NASH it may eventually lead to complications such as cirrhosis of liver, liver cancer, liver failure.

Non-alcoholic fatty liver disease can be interpreted as Santarpotha-vikara (disease which caused by taking excessive nourishing diet) which causes agnimandya, aamotpati and saamrasa formation and eventually lead to accumaltion of dosha in Yakrita.Parikara Yoga is mentioned in Chakradatta Yakritapleehaadhikarana 38/15-17. The Contents of Parikara Yoga have katu, tikta, kashaya rasa, ushna virya, laghu ruksha teekshna snigdha guna, katu vipaka ,kaphamedohar, raktaprasadaka, deepan and pachan properties. Most of the medicIine

NEED OF STUDY:
The treatment presently available are not satisfactory that can restrict hepatic steatosis and to limit liver cell injury and the occurrence of inflammation and fibrosis. Currently it is a great challenge for us to develop a drug that is effective in Non-alcoholic fatty liver disease patients exhibiting, obesity, insulin resistance, dyslipidaemia and oxidative stress. Ultrasonography for detection of fatty liver has played a breakthrough role for patients with or without biochemical abnormalities. Therefore, this study was planned to assess the role of Parikara Yoga in Yakrita Roga with special reference to Non-alcoholic fatty liver disease [NAFLD].

AIM AND OBJECTIVES:
AIM: To assess the efficacy of Parikara Yoga and Pathya in the management of Yakrita Roga w.s.r. to non-alcoholic fatty liver disease.
OBJECTIVES: 
Primary objective 1. Changes in USG findings and grading. 
Secondary objective 1. Changes in liver function test, lipid profile. 2. Changes in clinical sign and symptoms if any.

HYPHOTHESIS :
1.Null Hypothesis [Ho] There is no difference between the effect of trial drug Parikara Yoga and Placebo in the management of Yakrita Roga w.s.r. to Non-Alcoholic Liver Disease.
 2.Alternative Hypothesis [H1] There is significant difference between the effect of trial drug Parikara Yoga and Placebo in the management of Yakrita Roga w.s.r. to NonAlcoholic Fatty Liver Disease. .
.
POSOLOGY: All the patient fulfilling the criteria of diagnosis and inclusion will be randomly divided into two groups named as Group A and Group B consisting 20 patients in each group. 
Group A (Drug): 20 registered radiologically diagnosed patients of nonalcoholic fatty liver disease will be administered Parikara Yoga 1GM TID after meal, with anupana usnodaka with Pathya for 8weeks.
Group B (Placebo): 20 registered radiologically diagnosed patients of nonalcoholic fatty liver disease will be advised to Pathya with placebo (2 capsules each of 500mg filled with Roasted sooji powder) for 8 weeks.

Withdrawal Criteria:
..• Patients having any serious side effect even after enrolment in trial may be withdrawn from the study.
  • Patient himself want to withdraw from the clinical trial
















 
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