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CTRI Number  CTRI/2025/07/091548 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficasy of Rohitak Lauha in management of Non alcoholic fatty liver (NAFLD) 
Scientific Title of Study   A Clinical trail to Evaluate the efficacy of Rohitaka Lauha in the management of Yakrit Vikara w.s.r.t. Non alcoholoc fatty liver disease (NAFLD) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragati Ashok Katariya 
Designation  Professsor and Hod, dept of kayachikitsa 
Affiliation  Shri Dhanwantry Ayurvedic college and hospital, Chandigarh 
Address  Room no. 102, Department of Kayachikitsa, Shri Dhanwantry ayurvedic college and hospital, sector 46 B, chandigarh 160047
Room no. 102, Department of Kayachikitsa, Shri Dhanwantry ayurvedic college and hospital, sector 46 B, chandigarh 160047
Chandigarh
CHANDIGARH
-160047
India 
Phone  07814144288  
Fax    
Email  pragatidr5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaidya Rakesh Sharma 
Designation  President, Board of ethics and Registration comittee, NCISM 
Affiliation  NCISM, New delhi 
Address  Plot No. T-19, 1st & 2nd, Floor, Block_IV Dhanwantari Bhawan, Road No 66, Punjabi Bagh (West), New Delhi-110026 Delhi

Chandigarh
CHANDIGARH
-160047
India 
Phone  9814779242  
Fax    
Email  president.berism@ncismindia.org  
 
Details of Contact Person
Public Query  
Name  Vaidya Rakesh Sharma 
Designation  President, Board of ethics and Registration comittee, NCISM 
Affiliation  NCISM, New delhi 
Address  Plot No. T-19, 1st & 2nd, Floor, Block_IV Dhanwantari Bhawan, Road No 66, Punjabi Bagh (West), New Delhi-110026 Delhi
Plot No. T-19, 1st & 2nd, Floor, Block_IV Dhanwantari Bhawan, Road No 66, Punjabi Bagh (West), New Delhi-110026 Delhi
Chandigarh
CHANDIGARH
-160047
India 
Phone  9814779242  
Fax    
Email  president.berism@ncismindia.org  
 
Source of Monetary or Material Support  
Shri Dhanwantry Ayurvedic college and hospital chandigarh, 160047, Chandigarh, India 
 
Primary Sponsor  
Name  Pragati Ashok Katariya 
Address  #3198, sector 46 c, 160047, chandigarh, India 
Type of Sponsor  Other [self] 
 
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 Pragati Ashok Katariya  Shri Dhanwantry Ayurvedic college and hospital  room no. 102 Fisrt Floor, Department of Kayachikitsa, Shri Dhanwantry ayurvedic college and hospital, sector 46 B, chandigarh 160047
Chandigarh
CHANDIGARH 		 07814144288

pragatidr5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Shri Dhanwantry ayurvedic college and hospital chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E788||Other disorders of lipoprotein metabolism. Ayurveda Condition: YAKRU, (2) ICD-10 Condition:E788||Other disorders of lipoprotein metabolism. Ayurveda Condition: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rohitak Lauha, Reference: Rasa Ratna samucchaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients having Grade 1 to Grade 2 Fatty Liver changes on USG report.
2. Patients having NAFLD score -1.455 to 0.675.
3. Patient irrespective of sex, Caste and Religion.
 
 
ExclusionCriteria 
Details  1. Patients having more than Grade 3 A Fatty Liver on USG report.
2. Patients having NAFLD score more than 0.675.
3. Patients having any other metabolic disorders, malignancies, auto-immune disorders or life-threatening disorders
• Pregnant and lactating woman
• Patients with a previously established diagnosis of chronic disease including congestive heart failure, decompensated or severe lung disease, neoplasms, kidney disease, carriers of the human immunodeficiency virus (HIV), and advanced chronic liver diseases (Child-Pugh classification B and C) caused by any causal agent unrelated to NAFLD
• Recreational drug users;
• Patients with an average intake of more than 20 g of alcohol per day and or a history of alcoholic disease in abstention for less than 6 months
• Patients on prescribed medication including steroids, oestrogens, amiodarone, warfarin, anticonvulsants, antipsychotics, or chemotherapy drugs in the past 6 months
• Patients having history of infections, surgery, trauma, or hospitalization in the past 30 days
• Patients of chronic degenerative diseases of non-hepatic origin
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rohitak Lauh will reverse the changes of NAFLD (Non-Alcoholic Fatty Liver Disorder) in NAFLD SCORE  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
As secondary objectives, the following will be assessed:

Body mass index (BMI) and waist circumference (WC)

Glucose metabolism biomarkers including blood glucose and glycated haemoglobin (HbA1c)

Blood ferritin levels

Biomarkers of liver damage, including transaminases, gamma-glutamyl transferase (GGT), and alkaline phosphatase (AP) 		 45 days 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 
Date of First Enrollment (India)   25/08/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

RESEARCH QUESTION
Can the Rohitak Lauh reverse the changes of NAFLD (Non-Alcoholic Fatty Liver Disorder) in NAFLD SCORE?

5. HYPOTHESIS
Null Hypothesis (H0):
There is no efficacy of Rohitak Lauh in NAFLD (Non-Alcoholic Fatty Liver Disorder).

Alternative Hypothesis (H1):
There is significant effect of Rohitak Lauh in NAFLD (Non-Alcoholic Fatty Liver Disorder).

6. AIMS AND OBJECTIVES
Aim:
To evaluate the role of Rohitak Lauh in NAFLD with special reference to Yakrit Vikara (Non-Alcoholic Fatty Liver Disorder).

7. OBJECTIVES
Primary Objective:
To evaluate the role of Rohitak Lauh in NAFLD with special reference to Yakrit Vikara (Non-Alcoholic Fatty Liver Disorder) on the basis of NAFLD Score.

Secondary Objectives:
As secondary objectives, the following will be assessed:

            Body mass index (BMI) and waist circumference (WC)

            Glucose metabolism biomarkers including blood glucose, glycated hemoglobin (HbA1c)

            Blood ferritin levels

            Biomarkers of liver damage, including transaminases, gamma-glutamyl transferase (GGT), and alkaline phosphatase (AP)

8. PLAN OF STUDY
To fulfill the above-mentioned aims and objectives, the research work will be carried out as follows:

A. CONCEPTUAL STUDY
The Ayurvedic and modern literature pertaining to Yakrit Vikara with special reference to NAFLD will be compiled and reviewed critically.

B. CLINICAL STUDY
a. Source of Data:
110 subjects will be selected from OPD and IPD of Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh. Subjects will be randomly picked for the study using an open trial method in a single group after taking their consent.

b. Selection of Patients:
Selection of the patients will be done after investigations.

c. Criteria for Selection:

            Patients having classical signs and symptoms of Yakrit Vikara

            Patients having NAFLD score between -1.455 to 0.675

            Patients having Grade 1 to Grade 2 fatty liver changes on USG report

d. Inclusion Criteria:

            Patients having Grade 1 to Grade 2 fatty liver changes on USG report

            Age between 20 years and 70 years

           Patients having NAFLD score between -1.455 to 0.675

           Patients irrespective of sex, caste, and religion

e. Exclusion Criteria:

           Age less than 20 years or more than 70 years

           Patients having more than Grade 3A fatty liver on USG report

            Patients having NAFLD score more than 0.675

           Patients having any other metabolic disorders, malignancies, autoimmune disorders, or life-threatening disorders

           Pregnant and lactating women

           Patients with previously established diagnosis of chronic diseases including congestive heart failure, decompensated or severe lung disease, neoplasms, kidney disease, carriers of HIV, and advanced chronic liver diseases (Child-Pugh classification B and C) caused by any causal agent unrelated to NAFLD

           Recreational drug users

           Patients with an average intake of more than 20 g of alcohol per day and/or a history of alcoholic disease with abstention for less than 6 months 

            Patients on prescribed medication including steroids, estrogens, amiodarone, warfarin, anticonvulsants, antipsychotics, or chemotherapy drugs in the past 6 months

           Patients having history of infections, surgery, trauma, or hospitalization in the past 30 days

            Patients with chronic degenerative diseases of non-hepatic origin

f. Laboratory Investigations:

       Complete Blood Count (CBC)

       Serum Ferritin

        Liver Function Test (LFT)

       Gamma-Glutamyl Transferase (GGT)

        Renal Function Test (RFT)

       Lipid Profile

       HbA1c

       Random Blood Sugar

       Ultrasound (Whole Abdomen)

 
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