FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/02/023410 [Registered on: 18/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role Of Shubhdeep Liv-Gud Pill In Fatty Liver (Yakrutdalyodara) 
Scientific Title of Study   A Clinical Study To Evaluate The Therapeutic Effect Of Shubhdeep Liv-Gud Pill In The Management Of Yakrutdalyodara W.S.R to 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 Ajit Kumar Shrivastava 
Designation  M.D. Scholar 
Affiliation  Shubhdeep ayurved medical college and hospital, Indore 
Address  OPD of kayachikitsa room no G-10 Shubhdeep ayurved medical college and hospital

Indore
MADHYA PRADESH
452020
India 
Phone  9074676268  
Fax    
Email  dr.ajitshrivastava@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K Singh 
Designation  Professor 
Affiliation  Shubhdeep ayurved medical college and hospital, Indore 
Address  Department of kayachikitsa room no G-44 Shubhdeepp ayurved medical college and hospital

Indore
MADHYA PRADESH
452020
India 
Phone  9300681233  
Fax    
Email  doctoraksingh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh shrivastava 
Designation  Professor 
Affiliation  Shubhdeep ayurved medical college and hospital indore 
Address  Department of RSBK room no G-41 Shubhdeep ayurved medical college and hospital

Indore
MADHYA PRADESH
452020
India 
Phone  9993281713  
Fax    
Email  drshrivastava.akhilesh@gmail.com  
 
Source of Monetary or Material Support  
Dr Ajit Kumar Shrivastava Shubhdeep Ayurveda Medical College And Hospital, Indore 
 
Primary Sponsor  
Name  Shubhdeep Ayurveda Medical College And Hospital 
Address  Shubhdeep ayurved medical college and hospital, gram datoda,khandwa road Indore 452020 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Ajit kumar shrivastava  OPD of kayachikitsa room no G-10 Shubhdeep ayurved medical college and hospital  Village datoda khandwa road
Indore
MADHYA PRADESH 		 9074676268

dr.ajitshrivastava@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 
Comparator Agent  NIL  NIL 
Intervention  Shubhdeep Liv-Gud Pill  500 mg BID with lukewarm water 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient presenting with clinical feature of yakrutdalyodara(Fatty liver).
2. Patient with or without the clinical feature of yakrutdalyodara, diagnosed to be having USG whole abdomen where include for the study.
3. Patient age between 20-60 years with either sex.
4. Patient of alcoholic addiction, obesity, type-2 diabetes mellitus. 
 
ExclusionCriteria 
Details  1. Patient aged less than 20 yr and more than 60 years.
2. Patient with hepatic encephalopathy, systemic multiorgan syndrom, malignency of liver and cirrhosis of liver and prehepatic and hepatic coma, bleeding disorder, etc.
3. Pregnent women.
4. Hepatitis B and C.
5. Patient on steroid treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Improve power of digestion.
2) Relief in anorexia.
3) Relief in indigestion.
4) Relief in weakness.
5) Relief in fever.
6) Relief in constipation. 		 45th day. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   19/02/2020 
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="6"
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   In ayurveda there are 8 types of UDARA-ROGA have been described, in Ayurveda agnidosha and malavrudhi are resion of UDARA-ROGA. If there is suppresion of agni especially jatharagni, due to faulty life style, as a result of which dosha get accumulated in the kostha. This cause  vitiation of Pranavayu, Jatharagni, and Apanavayu. As liver play important  part of digestion, become enlarge due to vitiation of Agani and Dosha. Yakrutdalyodara developed due to vitiation of Kapha leads to mandagni caused by the continous intake of vidahi and abhishyandi aahara. The sign and symptoms of yakrutdalodara are closely related to Fatty liver. According to line of treatment of Yakrutdalyodara the SHUBHDEEP LIV-GUD PILL is selected. Its prepration have been reported to possess liver protection effect. This study is carried out in one group with pre -test and post -test design where in a minimum 30 patient suffering from Yakrutdalyodara of either sex between the age group of 20 - 60  years will be selected for the study. Final assessment of result is made on the basis of subjective & objective criteria. Appropriate statistical tests will applied. 
Close