| CTRI Number |
CTRI/2014/02/004410 [Registered on: 17/02/2014] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| 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 of Dabur Hepano tablet in comparison with a marketed Hepatoprotective formulation in Liver Disorder Patients |
|
Scientific Title of Study
|
A Randomized, Active Controlled, Multicentre, Prospective, Clinical Study to Compare the Efficacy and Safety of Dabur Hepano Tablet with a Marketed Liver Formulation in Liver Disorder Patients with Abnormal Liver Function Test (LFT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DA/HEP/2013/01, Version: 1.0 , Dated: 22/Oct /2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Overall Trial Coordinator |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra |
| Address |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs and Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Dabur Research and Development Centre
Dabur India Ltd
Plot No 22 Site IV
Sahibabad
Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9910200255 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyadhar Kumbhar |
| Designation |
Clinical Trial Monitor |
| 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
MAHARASHTRA
400068
India |
| Phone |
9960075536 |
| Fax |
|
| Email |
dr.vidyadhar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research & Development Centre
Dabur India Ltd, 22, Site IV, Sahibabd, Ghaziabad, U.P. -201010
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
| Type of Sponsor |
Other [Healthcare] |
|
|
Details of Secondary Sponsor
|
|
|
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 Kulkarni |
Ayurveda Research Center |
Ayurveda Research center.
2nd Floor, Ayurved Seva Sangh Nasik. Ganeshwadi Nashik.
Nashik
MAHARASHTRA |
9822537240
abhaynk@yahoo.com |
| Dr Sunil S Borkar |
Department of Kaychikitsa, ShriGurudeo Ayurved College |
Department of Kaychikitsa, ShriGurudeo Ayurved College, Gurukunj Ashram, Tal. Tosa,
Amravati
MAHARASHTRA |
9420411425
sborkar25@gmail.com |
| Dr Sagar More |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra |
Department of Kayachiktsa, 2nd Floor, MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra, Malwadi, Hadapsar, Pune-411028
Pune
MAHARASHTRA |
09822529950
docsagmo@yahoo.com |
| Dr Meenakshi Revedkar |
R A Podar Medical College (Ayu) |
Department of Kayachikitsa, 1st Floor, R A Podar Medical College (Ayu), Worli, Mumbai 400018
Worli
Mumbai 400018
Mumbai
MAHARASHTRA |
09421291561
meenakshirewadkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurveda Research center. Ayurved seva sangh nasik. Ganeshwadi Nashik |
Approved |
| Institutional Ethics Committee, MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra, Malwadi, Hadapsar, Pune |
Approved |
| Institutional Ethics Committee, R A Podar Medical College (Ayu), Worli, Mumbai 400018 |
Approved |
| Institutional Ethics Committee, Shrigurudeo Ayurved College, Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R945||Abnormal results of liver functionstudies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Hepano Tablet |
2 tablets at a time, twice daily for 8 weeks |
| Comparator Agent |
Marketed Ayurvedic formulation |
2 tablets at a time, twice daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Willing to provide informed consent to participate in the study
• Males or females 18-65 years of age.
• Diagnosis of hepatic disorder with abnormal LFT and clinical icterus
• Serum total bilirubin level more than equal to 2 mg/dL, AST or ALT >2 times ULN
• The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications
|
|
| ExclusionCriteria |
| Details |
• Pregnant or lactating mother
• Suspected hypersensitivity to contents of investigational product liver formulation
• Known case of hepatitis-B or hepatitis-C
• Obstructive Jaundice and Advanced liver diseases
• Subjects with serious illness,
• Current use of other herbal medicines for liver disorders or recent use within past two weeks
• Other conditions, which in the opinion of the investigators, makes 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
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in the Liver enzyme level from baseline to end of therapy compared between Hepano Tab and marketed liver formulation |
From baseline to end of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage change in the serum total bilirubin level, liver enzyme and subjective clinical improvement from baseline to subsequent visits and end of therapy |
From baseline to subsequent visits (Day 7, 14, 28) and end of therapy |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2014 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be a multicentre, randomized, double blinded, parallel-group, comparator study which is intended to evaluate the safety and efficacy of Hepano Tab in liver disorder subjects. Subjects with liver disorders of different etiologies in the age group of 18-65 years will be included in the study. Subjects will be randomized to either of the two treatment groups in 1:1 ratio. One group will receive Hepano Tablet and other will receive marketed product. Each group to get two tablets, twice a day for a period of 8 weeks. These subjects will be followed further for another 4 weeks after treatment period. The total duration of the study after randomization will be 12 weeks. Total completers for the study is planned to be 150 patients. The following parameters will be evaluated like Physical examination, Vital signs, Assessment of clinical improvement, Liver function test, Adverse Event (AE) assessments etc at various intervals of time. |