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CTRI Number  CTRI/2017/10/010082 [Registered on: 12/10/2017] Trial Registered Retrospectively
Last Modified On: 14/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study on Ayulite Capsules in Liver Diseases  
Scientific Title of Study   A Randomized, Open Label, Active Controlled,Multi-Centre,Prospective Clinical Study to Evaluate the Efficacy and Safety of Ayulite Capsules in Comparison with Marketed Formulation in Liver Disorder Patients with Abnormal Liver Functions Tests (LFTs). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
WLX/AYULITE/01, Version 1.0,Dated 20 Mar 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Deshpande 
Designation  Assistant Professor 
Affiliation  MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 
Address  Department of Kayachikitsa OPD No. 2 Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vandana Bade 
Designation  Manager - Clinical Trial Operation 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  8149507065  
Fax    
Email  vandana@targetinstitute.in  
 
Source of Monetary or Material Support  
Welex Laboratories Pvt. Ltd. 1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13  
 
Primary Sponsor  
Name  Welex Laboratories Pvt Ltd 
Address  1002, Marathon Innova Nextgen, Off Ganpatrao Kadam Marg, Lower Parel, Mumbai -13  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhay N Kulkarni  Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik  Ayurveda Research Center, 2nd Floor, Ayurved Seva Sangh Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA 		 9822537240

abhaynk@yahoo.com 
Dr Vaishali Deshpande  MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra  Department of Kayachikitsa OPD No. 2 Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA 		 9096082950

dr.vaishalid@gmail.com 
DRSHRILATHA KAMATH T  SHRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA  POST GRADUATE DEPARTMENT OF KAYACHIKITSA & MANASAROGA GROUND FLOOR OPD NO. 7 & 8 SHRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA, KUTHADY, UDUPI – 574118
Udupi
KARNATAKA 		 9964899638

shri9503@gmail.com 
Dr Sunil S Borkar  Shri Gurudeo Ayurved College and Hospital Amravati  Department of Kaychikitsa Shri Gurudeo Ayurved College Gurukunj Ashram Tal Tiosa Amravati 444902
Amravati
MAHARASHTRA 		 9420411425

sborkar25@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Gurudeo Ayurved College, Amravati   Approved 
Institutional Ethics Committee, ASS Ayurved Mahavidyalaya, Nashik   Approved 
INSTITUTIONAL ETHICS COMMITTEE, SHRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA, KUTHADY, UDUPI-574118 KARNATAKA  Approved 
Institutional Review Board For Research, MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra, Malwadi Hadapsar Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Liver Disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AYULITE Capsules  AYULITE Capsules contains Andrographis paniculata, Tecomella undulate, Tephrosia purpurea, Phyllanthus niruri, Eclipta alba, Holarrhena antidysenterica, Glycyrrhiza glabra, Fumaria parviflora, Tinospora cordifolia, Hedychium spicatum, Boerhaavia diffusa. Dosage and Treatment Duration: 2 Ayulite capsules twice daily orally after food with water. 
Comparator Agent  Marketed Formulation  Contains Achillea millefolium, Cichorium intybus, Himsra, Jhavuka, Kakamachi, Kasamarda, Mandur Bhasma, and Terminalia Arjuna Dosage and Treatment Duration: 2 Tablets twice daily orally after food with water.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
2.Diagnosis of hepatic disorder with abnormal LFT and clinical icterus as manifested by one or combination of the symptoms like - dark colored urine, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, indigestion, aversion to smoking, right upper abdominal discomfort, pain or feeling of pressure.
3.Serum total bilirubin level ≥ 2 mg/dL and/or clinically significant increase in ALT/ AST levels (at least more than 2.5 times of normal limits).
4.The subject is able and willing to undertake all study-required Procedures and has ability to take oral medications.
5.Subjects willing to practice effective method of contraception during study period.
 
 
ExclusionCriteria 
Details  1.Pregnant or lactating women.
2.Subject with known hypersensitivity to contents of Ayulite Capsule or contents of marketed formulation.
3.Subjects suffering from active Hepatitis B or C.Obstructive Jaundice (diagnosed clinically and biochemically).
4. Known case of 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.Current use of any marketed herbal preparation for Jaundice treatment within past two weeks.
7.Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.
8.The subject is currently participating/participated in any clinical trial for past 90 days
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Assessment of changes in the serum total bilirubin level from baseline to end of therapy in the two groups.
2. Assessment of changes in AST and ALT levels from baseline to end of therapy in the two groups.
 		 Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75 
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of changes in the serum total bilirubin, AST and ALT levels from baseline to each study visit.
2.Assessment of changes in subjective clinical improvement assessment scale
3.Assessment of adverse events, adverse drug reactions, safety lab parameters
 		 Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/06/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet Done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

It is A Randomized, Open Label, Active Controlled, Multi-Centre, Prospective Clinical Study to Evaluate the Efficacy and Safety of Ayulite Capsules in Comparison with Marketed Formulation in Liver Disorder Patients with Abnormal Liver Functions Tests (LFTs). The study will be conducted at three sites in India. The dose of Ayulite will be 2 capsules twice daily orally after food with water for 60 days or till complete resolution of the condition. The dose of marketed formulation will be 2 tablets twice daily orally after food with water for 60 days or till complete resolution of the condition. The Primary Objectives will be to evaluate changes in the serum total bilirubin level from baseline to end of therapy in the two groups and changes in AST and ALT levels from baseline to end of therapy in the two groups on day Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75. The secondary objectives will be to evaluate changes in the serum total bilirubin, AST and ALT levels from baseline to each study visit,  changes in subjective clinical improvement assessment scale,  adverse events, adverse drug reactions, safety lab parameters on Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75.

 
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