FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/03/008052 [Registered on: 09/03/2017] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To study the acceptance of and adherence to 10-Day treatment of zinc Sulphate dispersible tablets 
Scientific Title of Study   A Prospective, Open-label, Multicenter, Phase 3 Study to Assess the Acceptability of and Adherence to a 10-Day Regimen of Zinc Sulphate Dispersible Tablets for Treatment of Acute Childhood Diarrhea. 
Trial Acronym  ZNDT 
Secondary IDs if Any  
Secondary ID  Identifier 
Ipca/ZNDT/PIII-14,Version number 3; Dated 14/04/2016   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Agrawal  
Designation  Professor and Head of Department, Department of Pediatrics 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Acharya Donde Marg, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9821014384  
Fax    
Email  dr_mukesh_agrawal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Somesh Bolegave 
Designation  Medical Monitor 
Affiliation  SIRO Clinpharm Pvt. Ltd 
Address  Kalpataru Prime, 1st floor Unit Nos 3 & 4 Plot no D3 Road no 16 Wagle Industrial Estate Thane West400604 Maharashtra INDIA

Thane
MAHARASHTRA
400604
India 
Phone  02261088054  
Fax  02261088281  
Email  somesh.bolegave@siroclinpharm.com  
 
Details of Contact Person
Public Query  
Name  Nitin Chandurkar 
Designation  Vice President 
Affiliation  Ipca Laboratories Ltd. 
Address  Plot 142AB Kandivli Industrial Estate Kandivli West Mumbai 400067

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  02266474623  
Fax    
Email  nitin.chandurkar@ipca.com  
 
Source of Monetary or Material Support  
Ipca Laboratories Ltd, 142-AB, Kandivli Industrial Estate, Kandivli West, Mumbai 400067, India  
 
Primary Sponsor  
Name  Ipca Laboratories Limited 
Address  Plot 142-AB, Kandivli Industrial Estate, Kandivli West, Mumbai: 400067 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Malaysia  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apurba Ghosh  Institute of Child Health  11, Dr. Biresh Guha Street, Kolkata-700017, India
Kolkata
WEST BENGAL 		 9433009788

apurbaghosh@yahoo.com 
Dr Mukesh Agarwal  King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College  Acharya Donde Marg, Parel, Mumbai-400012, Maharashtra
Mumbai
MAHARASHTRA 		 9821014384

dr_mukesh_agrawal@yahoo.co.in 
Dr Swapnil Janbandhu  Lifepoint Multispeciality Hospital, Pune  Research room, 3rd floor, 145/1, Mumbai Bangalore highway, Near Hotel Sayaji, Pimpri Chinchwad, Wakad, Pune
Pune
MAHARASHTRA 		 9028756287

janbandhu.swapnil117@gmail.com 
Dr Raghvendra Singh  Maulana Azad Medical College & Associated Lok Nayak Hospital.  Maulana Azad Medical College & Associated Lok Nayak Hospital, New Delhi-2, India
New Delhi
DELHI 		 9811898693

drraghvendrasingh@gmail.com 
Dr Sandeep Shinde   Sterling Multispeciality Hospital, Pune  Consultant, Department of Pediatrics, Vitthal Rakhumai Road, Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Pune- 411044
Pune
MAHARASHTRA 		 9822075706

dr.sandeepshinde@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee , Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012  Approved 
Institutional Ethics Committee, Maulana Azad Medical College & Associated Hospitals, New Delhi  Approved 
Institutional Ethics Committee- Institute of Child Health, Dr. Biresh Guha street, Kolkata, West Bengal-700017  Approved 
Lifepoint Research Ethics Committee, Pune  Approved 
Sterling Hospital Institutional Ethics Committee, Pune   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R197||Diarrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Zinc Sulphate Dispersible Tablet 20 mg  Zinc Sulphate Dispersible Tablet 20 mg for 10 days. 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  59.00 Month(s)
Gender  Both 
Details  Subject with acute diarrhea (3 or more loose, liquid, or watery stools in past 24 hours).

Subject must be healthy except for study-related disease condition in the opinion of the
Investigator.

Subject’s parent/guardian should be ready to comply with the study procedures and adhere to the prohibitions and restrictions specified in the protocol.

Subject’s parent/guardian willing to sign an ICF indicating that they have understood the purpose of and procedures required for the study, and are willing for their child’s participation in the study.
 
 
ExclusionCriteria 
Details  Subject with pedal edema or who is severely dehydrated e.g. abnormally sleepy or lethargic, sunken eyes, drinking poorly or not at all, tachycardia, tachypnea, markedly reduced skin turgor; and require hospitalization.

Subject with co-morbidity associated with excessive vomiting, e.g., whooping cough, pylorospasm, congenital pyloric stenosis, hiatus hernia, other obstructive defects of the gastrointestinal tract or a history of cow’s milk allergy, etc.

Subject with any other known systemic complication, e.g. pneumonia, meningitis, sepsis, paralytic ileus, severe malnutrition, hypoglycemia, serum electrolyte disorders, seizure that require admission to the hospital.

Subject with chronic or persistent diarrhea and dysentery, had developmental delay (>1 year behind milestones), or having a birth defect or having a medical condition that could interfere with the ability to discriminate taste, e.g., common cold or a sinus or bronchial infection.

Subject already on zinc supplementation, zinc fortified infant formulae, or receiving drugs that may inhibit zinc absorption such as iron supplements, penicillamine, sodium valproate, and ethambutol.

Subject who has taken prescription drugs other than those prescribed for diarrhea during the preceding 24 hours.

Subject with hypersensitivity to zinc or has known food or drug allergies to any of the constituents of the study drug product.

Subject who has participated in any other clinical study within past 30 days or has participated in a similar study for zinc sulphate earlier.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the acceptability in terms of adherence of zinc sulphate dispersible tablets.  10 Days  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the acceptability in terms of palatability of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea.


To compare the efficacy of zinc sulphate dispersible tablets in children aged between 3 to ≤18 months and 18 to 59 months.


To assess safety of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea.
 		 10 Days 
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "310"
Final Enrollment numbers achieved (India)="129" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/03/2017 
Date of Study Completion (India) 19/02/2018 
Date of First Enrollment (Global)  16/12/2016 
Date of Study Completion (Global) 12/09/2017 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is A Prospective, Open-label, Multicenter, Phase 3 Study to assess the acceptability of and adherence to a 10-Day regimen of Zinc Sulphate dispersible tablets for treatment of Acute Childhood Diarrhea in 310 patients.

 

The study is to be conducted in four centers in India and eight in Malaysia.

 

The primary outcome measures will assess the acceptability of and adherence to a 10-Day Regimen of Zinc Sulphate Dispersible Tablets.

 

The secondary outcomes will be to assess the safety and  acceptability in terms of palatability of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea and to compare the efficacy of zinc sulphate dispersible tablets in children aged between 3 to ≤18 months and >18 to 59 months. 
Close