FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056191 [Registered on: 07/08/2023] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study between phaltrikadi Kashaya & phaltrikadi Kashaya Ghana vati in the management of non alcoholic fatty liver disease  
Scientific Title of Study   A clinical study to evaluate the comparative efficacy of phaltrikadi Kashaya and phaltrikadi Kashaya Ghana vati in the management of 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  Prof Vijay Chaudhary 
Designation  Principal cum Dean,  
Affiliation  Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital 
Address  Room no 317 of Kayachikitsa Department in Hospital building of Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital, Paprola, Distt kangra

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418130228  
Fax    
Email  drvijaychaudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manik Soni 
Designation  Lecturer 
Affiliation  Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital 
Address  Room no 317 Kayachikitsa Department in Hospital building of R.G.G.P.G.Ayu. College Paprola

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9816842425  
Fax    
Email  drmsony@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mehak Chaudhary  
Designation  P. G. Scholar 
Affiliation  Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital 
Address  Room no 317 Kayachikitsa Department of Hospital building of R.G.G.P.G.Ayu. College Paprola

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805410348  
Fax    
Email  cmehak53@gmail.com  
 
Source of Monetary or Material Support  
R.G.G.P.G.Ayurvedic College and Hospital, Paprola 
 
Primary Sponsor  
Name  Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola  
Address  Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital  
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 
Prof Vijay Chaudhary   RAJIV GANDHI GOVT POST GRADUATE AYUREDIC COLLEGE & HOSPITAL PAPROLA DISTT KANGRA (HP)  OPD no 207 and 220 and IPD room no 317 of Hospital building in Kayachikitsa Department of Hospital building
Kangra
HIMACHAL PRADESH 		 9418130228

drvijaychaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human)  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: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Phaltrikadi kashaya , Reference: Chakradatt pandurogadi chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Phaltrikadi Kashaya Ghana Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Altered serum liver enzymes- AST and/or ALT >normal (35-40U/L) - <2times of upper normal limit 
 
ExclusionCriteria 
Details  Patients consuming alcohol
Patients having Hepatitis B/ Hepatitis C, malignancy of liver
USG evidence of cirrhosis or necrosis of liver 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A clinical study to evaluate the comparative efficacy of phaltrikadi Kashaya and phaltrikadi Kashaya Ghana vati in the management of non alcoholic fatty liver disease   12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the clinical safety of phaltrikadi Kashaya & phaltrikadi Kashaya Ghana vati in the management of non alcoholic fatty liver disease   12 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   22/08/2023 
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="0"
Months="3"
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   I would like to publish my work after completion of my research work as soon as possible. Patients will be selected from OPD/IPD of R. G. G. P. G. Ayurvedic College, Paprola 50 Patients will be divided into 2 groups and a comparative  study will be made to know the efficacy of Phaltrikadi kashaya and phaltrikadi Kashaya Ghana vati in the management of Non Alcoholic Fatty Liver Disease. 
Close