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CTRI Number  CTRI/2026/01/100886 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 05/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Study of Kalmeghanavayasa Lauha and Arogyavardhini Vati in the Management of Fatty Liver Disease (MAFLD)  
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KALMEGHANAVAYASA LAUHA AND AROGYAVARDHINI VATI IN YAKRIT ROGA WITH SPECIAL REFERENCE TO MAFLD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhuvnesh Kumar Gothwal 
Designation  PG scholar 
Affiliation  National institute of Ayurveda, Jaipur 
Address  Department of Kayachikitsa, National institute of Ayurveda , Deemed to be university, Near Jorawar Singh gate, Amer road, Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9928309993  
Fax    
Email  bhuvnesh.gothwal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Kumar Sahu 
Designation  Professor 
Affiliation  National institute of Ayurveda, Jaipur 
Address  Department of Kayachikitsa, National institute of Ayurveda , Deemed to be university, Near Jorawar Singh gate, Amer road, Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9950708106  
Fax    
Email  drajaysahu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Kumar Sahu 
Designation  Professor 
Affiliation  National institute of Ayurveda, Jaipur 
Address  Department of Kayachikitsa, National institute of Ayurveda , Deemed to be university, Near Jorawar Singh gate, Amer road, Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9950708106  
Fax    
Email  drajaysahu@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India Jaipur RAJ 302002 India 
 
Primary Sponsor  
Name  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 Rajasthan 302002 India Jaipur RAJ 302002 India 
Type of Sponsor  Research institution and hospital 
 
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 Bhuvnesh Kumar Gothwal  National Institute of Ayurveda, Deemed to be university.   OPD room no. 1, 18,25 ,department of Kayachikitsha, Near Jorawar Singh gate, Amer road Jaipur Rajasthan,India- 302002
Jaipur
RAJASTHAN 		 9928309993

bhuvnesh.gothwal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee-National institute of ayurveda  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: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kalmeghnavayas Lauh, Reference: Siddh yog sangrah ,vaidhya yadav ji trikam ji aacharya , pandu rogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Arogyavardhini vati, Reference: Ras ratn sammuchya Visapadicikitsa Adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex male or female
2. Age group equal and more then18 years and equal and less then 60 years
3. USG finding suggestive of fatty liver grade 1 and 2.
4.Clinical sign and symptoms suggesting of Yakrita Roga that Aruchi ,Daurablya,
Avipak,Aadhman, Vibandh.
5.Willingness to participate in the study and provide informed consent. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women.
2.Patients with history of autoimmune hepatitis, drug abuse, Acute and chronic
hepatitis.
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 having blood pressure 160/90 mm of Hg and more according JNC-8 .
5.Patient of DM type 1 (IDDM).
6.Patients not willing to fill consent forms. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in USG grading of fatty liver from baseline to the end of the treatment period.  Baseline , 30th day ,60th day ,end of treatment period. 
 
Secondary Outcome  
Outcome  TimePoints 
To change in the intensity of the symptoms associated with Yakrit roga , and LFT ,
RFT, CBC, FBS HbA1C,ESR comparative effect of these two drugs 		 Baseline , 30th day ,60th day ,end of treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/06/2026 
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="6"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

 Metabolic dysfunction-associated fatty liver disease (MAFLD) has become a major worldwide health issue, prompting a shift in the perception and classification of nonalcoholic fatty liver disease (NAFLD )                          

In Ayurveda, it is believed that mandagni is the root cause of all udararogas. There are 8 types of udararoga have been described in samhitas .Metabolic associated fatty liver disease has increased rapidly due to our faulty lifestyle and dietary habits like excessive use of fats, antagonistic food combinations etc. it is increasing parallel with obesity, diabetes mellitus and metabolic syndrome.  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 MAFLD. Also Increased demand in Ayurveda treatment, as ayurveda has become the safe place due to its non or negligible side effect, cost effectiveness of the drugs and easy availability of medicines.

Therefore, this study was planned to assess the role of Kalmeghnavayasa Lauha and Arogyavardhini vati with special reference to Metabolic associated fatty liver disease [MAFLD]. The study entitled as "A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KALMEGHANAVAYASA LAUHA AND AROGYAVARDHINI VATI IN YAKRIT  ROGA WITH SPECIAL REFERENCE TO MAFLD’’.


 
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