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CTRI Number  CTRI/2025/04/084033 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Ayurvedic drug formulation on liver health 
Scientific Title of Study   A randomized, double-blind clinical study to assess efficacy and safety of polyherbal formulation in non-alcoholic fatty liver patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PALS NAFLD version 2   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarvesh Kumar Singh 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda Jaipur  
Address  Room no 116, Department of Panchakarma, National Institute of Ayurveda, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  08739860237  
Fax    
Email  sarveshksingh21@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Sarvesh Kumar Singh 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda Jaipur  
Address  Room no 116, Department of Panchakarma, National Institute of Ayurveda, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  08739860237  
Fax    
Email  sarveshksingh21@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Kshipra Rajoria 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Room no.113 A, Department of Panchakarma, National institute of Ayurveda, Jorawar Singh Gate, Jaipur, Rajasthan, India.

Jaipur
RAJASTHAN
302002
India 
Phone  09001454100  
Fax    
Email  kshiprarajoria@gmail.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda,Jaipur,India 
 
Primary Sponsor  
Name  PALS Limited 
Address  A1-301, Wonderwall, Concord Portia Lane, Balewadi, N, Pune-411 045 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sarvesh Kumar Singh  National Institute of Ayurveda, Jaipur  Room no.113 A,Department of Panchakarma, National Institute of Ayurveda, Jorawar Singh Gate, Jaipur, India
Jaipur
RAJASTHAN 		 91-8739860237

sarveshksingh21@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:K759||Inflammatory liver disease, unspecified. Ayurveda Condition: UDARA/UDARAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Phalatrikadi Kashaya, Reference: Bhaisajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Kashaya will be provided in syrup form
2Intervention ArmDrugOther than Classical(1) Medicine Name: PAYULV, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: PAYULV 10 ml syrup consists of 300 mg dose (600mg/day)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Diagnosis of hepatic disorder with abnormal LFT with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure.
3.Subjects willing to sign inform consent form. 
 
ExclusionCriteria 
Details  1. Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis B or C) and biliary obstruction
2. AST > more than 500 U/L or ALT > more than 300 U/L
3. Suspected hypersensitivity to contents of study drug
4. Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer)
5. Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer
6. Patients with a renal failure
7. Pregnant or lactating women
8. Subjects with moderate to high physical activity having energy expenditure of 3.5 to 7 kcal/min
9. Other conditions, which in the opinion of the investigators, make the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in serum total bilirubin, AST and ALT   baseline to 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of change in symptoms of liver disease like anorexia, fatigue, abdominal pain, and nausea.  baseline to 12 weeks. 
Adverse events profile  baseline to 12 weeks. 
Compliance and tolerability of the product throughout the study .  baseline to 12 weeks. 
 
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 3 
Date of First Enrollment (India)   15/04/2025 
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="2"
Months="0"
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  

In the present study, 60 subjects with clinical symptoms of Non-Alcoholic Fatty Liver Disease (NAFLD) will be subjected to two ayurvedic formulations in two equally randomized arms of 30 participants each for 12 weeks. The efficacy and safety of these treatments will be assessed through LFT, clinical signs and symptoms, as well as reported adverse events, both reported and self-observed.
 
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