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CTRI Number  CTRI/2018/10/016215 [Registered on: 30/10/2018] Trial Registered Prospectively
Last Modified On: 26/10/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   An observational study of Controlled Release Nitroglycerin in patients with angina. 
Scientific Title of Study   An observation study to assess safety and efficacy of Tablet NGfenceTM 2.6/6.4 mg (Controlled Release) in patients with Angina 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Bhavesh Vyas 
Designation  Director 
Affiliation  4Care Lifescience Private Limited 
Address  4Care Lifescience Private Limited, BF, 2nd Floor, Sumeru Center, Near Parimal under bridge, Off C G Road, Paldi, Ahmedabad-380007

Ahmadabad
GUJARAT
380007
India 
Phone    
Fax    
Email  bhavesh4care@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Bhavesh Vyas 
Designation  Director 
Affiliation  4Care Lifescience Private Limited 
Address  4Care Lifescience Private Limited, BF, 2nd Floor, Sumeru Center, Near Parimal under bridge, Off C G Road, Paldi, Ahmedabad-380007

Ahmadabad
GUJARAT
380007
India 
Phone    
Fax    
Email  bhavesh4care@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Nishant Upadhyay 
Designation  Product Manager 
Affiliation  4Care Lifescience Private Limited 
Address  4Care Lifescience Private Limited, BF, 2nd Floor, Sumeru Center, Near Parimal under bridge, Off C G Road, Paldi, Ahmedabad-380007

Ahmadabad
GUJARAT
38007
India 
Phone    
Fax    
Email  pmt4care@gmail.com  
 
Source of Monetary or Material Support  
4Care Lifescience Private Limited BF, 2nd Floor, Sumeru Center, Near Parimal under bridge, Off C G Road, Paldi, Ahmedabad-380 007  
 
Primary Sponsor  
Name  Care Lifescience Private Limited 
Address  BF, 2nd Floor, Sumeru Center, Near Parimal under bridge, Off C G Road, Paldi, Ahmedabad-380 007  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Care Lifescience Private Limited  BF, 2nd Floor, Sumeru Center, Near Parimal under bridge, Off C G Road, Paldi, 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 66  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DIPAK MUNSHI  SHREE BAJRANGDASBAPA HOSPITAL  PANWADI CHOWK BHAVNAGAR
Bhavnagar
GUJARAT 		 9925138587

dpmunshi@gmail.com 
Sanjivani Hospital   Anis Mansuri  Near Tower, Siddhapur
Patan
GUJARAT 		 9825348743

dranisrubi@yahoo.com 
Dr Ashok C Shah  Dr Ashok shahs hospital   101, krishna palace , Bhagol, surat
Surat
GUJARAT 		 9824158432

drashok51@gmail.com 
Dr Saurabh Mehta  Praja Clinic  Ground Floor, Panchavati Apartment, Besides Convent school, Gandevi Road, Lunsikui, Navsari
Navsari
GUJARAT 		 9426873603

mdrsaurabh@gmail.com 
Dr Rajendra P Padia  Sanjivani Hospital  Opp.Patelwadi , Nootan Nagar Mahuva
Bhavnagar
GUJARAT 		 9824225757

drrppadia@gmail.com 
Dr B K Soni  Aashirwad Hospital  Subhdranagar,Patan
Patan
GUJARAT 		 9825016635

drbksoni515@gmail.com 
Dr Bhasmang Trivedi  Adarsh Hospital  Near Sardar Garden, Kalol, Gandhinagar-Gujarat - 382721,
Gandhinagar
GUJARAT 		 9409340863

trivedibhasm@gmail.com 
Dr Sandeep S Desai   Amit Hospitals  Opp Avabai High School, Halar Road, Valsad, Gujarat 396001
Valsad
GUJARAT 		 9825120393

dradsan@yahoo.com 
Dr Shailesh Trivedi  Anand Hopital  Vadodara
Vadodara
GUJARAT 		 9825802172

drsctrivedi26@gmail.com 
Dr Mohammed Akil Usmangani  Anas Medical Nursing Home  B-Sagar Avanue, Nr. Ambar Tower, Sarkhej, Ahmedabad- 380005
Ahmadabad
GUJARAT 		 07926826058

drakilpatni@yahoo.com 
Dr Ajay Mehta  Ani Hospital  103, Welcome Tower, Rander Road, Tadwadi, Tadwadi, Surat, Gujarat 395009
Surat
GUJARAT 		 9825118583

dr_ajay.mehta@rediffmail.com 
Dr Krushna Tandel  Arpan Hospital  Opp. HDFC Bank, Dungri, Valsad, Gujarat.
Valsad
GUJARAT 		 9825270851

krushna.tandel@yahoo.com 
Dr Ashok Israni  Asha Hospital  Modasa, Arvalli, Gujarat, India
Sabar Kantha
GUJARAT 		 9974363834

isranidrashok@gmail.com 
Dr Ramesh R Modi  Atit Clinic & Medical Nursing Home  12/3156-B, Bhajiwali Pole, Bhagal, Surat-395003.
Surat
GUJARAT 		 2779901

dr_ramesh_modi@yahoo.com 
Dr V C Chauhan  Atmajyoti Cardiac Clinic  71, Atmajyoti Nagar, B/H Ellora Park, Nr. Atmajyoti Ashram, Vadodara. Gujarat, India.
Vadodara
GUJARAT 		 9825200175

vcchauhan8@yahoo.com 
Dr Rushiraj Suthar  Avarda Hospital  Valasana Road, Idar, Sabarkantha - 383430, Near Idar College
Sabar Kantha
GUJARAT 		 02778250253

rishabhsuthar@gmail.com 
Dr Salim Ganirakwala  Aziz Hospital  207, Newheaven Enclave, Nr. Panigate Petrol Pump, Panigate, Vadodara
Vadodara
GUJARAT 		 9428507862

murtazasalim22@gmail.com 
Dr Hasmukh Bavadia  Bavadia Hospital  Bavadia Hospital, Una
Junagadh
GUJARAT 		 9925232380

hmbavadia@gmail.com 
Dr Paresh R Mehta  Bhajiyawala Hospital  F 4 Shaktivijay Complex 1st Floor, New Shakti Vijay Society, Nr Baroda Pristage Varachha Road, Surat - 395006 Gujarat
Surat
GUJARAT 		 9825506849

drparesh1177@gmail.com 
Dr Sandeep Shah  Bhumi Nursing Home  Vadodara
Vadodara
GUJARAT 		 9825041383

bhuminh@gmail.com 
Dr Dinkar Goswami  Civil Hospital  C/o Civil Hospital, Gandhinagar HO, Gandhinagar-Gujarat - 382010, Opposite Pathik Ashram, Opposite S T Depot
Gandhinagar
GUJARAT 		 9825070923

dngo080167@gmail.com 
Dr Karishma Matai  Dashashrimali Hospital  Kotharia Naka, Rajkot - 360001, Near Soni Bazar Main Road
Rajkot
GUJARAT 		 9925529932

karishma156@gmail.com 
Dr Lalji Patel  Dharti Hospital,   Highway Road, Opposite Gayatri Mandir Deesa, Banaskantha - 385535
Banas Kantha
GUJARAT 		 9427372859

drlapatel@yahoo.com 
Dr Vinayak Bhanvadiya  Dr Bhanvadiya  Keshod
Junagadh
GUJARAT 		 9408491471

vbhanvadiya@gmail.com 
Dr Dhiren Bakshi  Dr Dhiren Bakshi  Aditya Complex, Nr. Fuwara, Besides BSNL office, Navsari.
Navsari
GUJARAT 		 9537421812

dhirenbakshi@yahoo.com 
Dr Rishit Nandpara  Dr Nandpara Hospital  Main Post Office Chowk, Dhoraji, Gujarat
Rajkot
GUJARAT 		 9687274558

ranadpara@gmail.com 
Dr Chandraprakash Tindwani  Dr Tindwanis Clinic  1st Floor, Kandhari Chamber, Patia, Saijpur Bogha, Ahmedabad-382345
Ahmadabad
GUJARAT 		 07922815188

ct.tindwani@yahoo.com 
Vinod Bhatt  Gayatri hospital   Himmatnagar
Vadodara
GUJARAT 		 9824091137

vinod.bhatt@icloud.com 
Dr Jignesh Shah  HET Medical Hospital  405, Radhe Kishan Arista, Opp. Hirabai Tower, Maninagar, Ahmedabad.
Ahmadabad
GUJARAT 		 9904333669

drjignesh_shah29@yahoo.com 
Dr Sachin Thacker  J K Hospital  Siddhachal Building 1st Floor, Hospital Road, Bhuj
Kachchh
GUJARAT 		 9909029186

drthackersachin@gmail.com 
Dr Keyur Baxi  Jeevdeep Hospital  Opp. Pancheshwar Tower, Jamnagar, Gujarat, India
Jamnagar
GUJARAT 		 9825112647

kjbaxi@gmail.com 
Dr Darshan Jotangia  Jivandeep Hospital  Opp. Shri Ram Market, Dholka, Ahmedabad
Ahmadabad
GUJARAT 		 9824087397

darsh_j19@hotmail.com 
Dr Vishal Desai  Jiya Hospital  Hosptal Road, Opp. Bank of Baroda, Bhuj
Kachchh
GUJARAT 		 9898071963

drveesum@gmail.com 
Dr Chirag Patel  Kakadiya Hospital  421 B/s Sukh Sagar Complex, LBS Road, Opposite Dinesh Chambers, Bapunagar, Ahmedabad, Gujarat 380025
Ahmadabad
GUJARAT 		 07922205854

pateldrchirags@gmail.com 
Dr Maulik Kaneriya  Kaneriya Hospital  Junagadh
Junagadh
GUJARAT 		 9904240805

maulik26011989@gmail.com 
Dr R D Koshiya  Koshiya Clinic  Jagnath Plot, Nr. Yagnik Road Rajkot
Rajkot
GUJARAT 		 9879330093

rdkoshiya@gmail.com 
Dr Samir Nayak  Krishna Hospital  Krishna Complex, Opp.Raiya Telephone Exchange., 150 Feet Ring Rd, Raval Nagar, Rajkot, Gujarat 360005
Rajkot
GUJARAT 		 9825230092

samirnayak77@gmail.com 
Dr Ishan Kanzariya  Lifeline Hospital  Savasar Plot Main Road, Morbi - 363641, Above Sbi Branch
Rajkot
GUJARAT 		 9662329990

ishankanzaria53@gmail.com 
Dr Mohsin lulaniya  Lulaniya Hospital  Dhoraji
Rajkot
GUJARAT 		 9712356786

dr.mohsinlulaniya@gmail.com 
Dr Rajesh Upadhyay  Medicare Hospital  Nr. Railway Station, Kodinar, Gujarat.
Junagadh
GUJARAT 		 9824390754

drrajesh_upadhyay2007@hotmail.com 
Dr Rajan Bhagora   Meera hospital  Bhiloda
Sabar Kantha
GUJARAT 		 9925034409

drrajanmeera@yahoo.com 
Dr Viral Mehta  Mehta Hospital  58, Digvijay Plot, Jamnagar
Jamnagar
GUJARAT 		 9898255941

drvirmehta1@gmail.com 
Dr Devang Desai  Mrunal Hospital  Devashya, Bechar Road, Valsad
Valsad
GUJARAT 		 9925043381

mrunalhospital@yahoo.com 
Dr Chandravadan Nahar  Nahar Hospital  2/215, Rustampura, Main road, Surat,- 395002
Surat
GUJARAT 		 9825059900

dr.chnahar@gmail.com 
Dr Rakesh Patel  Naklank Hospital  Sanala Rd, Sardar Nagar, Morbi, Gujarat 363641
Rajkot
GUJARAT 		 9909043543

drrakeshsanja@gmail.com 
Dr Kishan Jani  Navjeevan Nursing Home  28/29, Anandnagar Society, Productivity Road, Vadodara - 390003
Vadodara
GUJARAT 		 02652323200

jani.kishu@hotmail.com 
Dr Vijay Mehta  PARIJAT MEDICAL HOSPITAL  RANDER RAOD , SURAT
Surat
GUJARAT 		 9888270150

vmehtadr@gmail.com 
Dr Jagdish Patel  Patel Cardiac Care  Adarsh Complex, Jail Road, Nr. Nilambag Circle, Bhavnagar, Gujarat, India
Bhavnagar
GUJARAT 		 9825952050

pdrjagdish2@gmail.com 
Dr Biren Nayak  Pratham Hospital  A-18, Bhagyoday Society 2, Pawapuri Road, Ghatlodia, Ahmedabad, Gujarat 380061
Ahmadabad
GUJARAT 		 9824053696

bijun89@yahoo.com 
Dr Shabbir Gadi  Raj Clinic  112, Abhinav Arcade, Ashram Road, Ellis Bridge, Ahmedabad - 380006, Near Khothawala Flats, Pritamnagar.
Ahmadabad
GUJARAT 		 9909644821

shabbirg78@yahoo.com 
MITABEN PASSWALA  Ravija Medical Center  303, KINARI APARTMENT , NEAR MAKKAI PUL, Surat
Surat
GUJARAT 		 0261395001

mspasswala@gmail.com 
Dr Dhiren C Patel  SANJIVANI HOSPITAL  SILVER POINT , BHARAT ROAD, SURAT
Surat
GUJARAT 		 02612238600

sanjivanihospitalsurat@gmail.com 
Dr Shailesh Jethva   Sardar Hospital  Katargam, surat
Surat
GUJARAT 		 9879397811

shaileshjethwa@rediffmail.com 
Dr Kanti N Patel  Saujanya Clinic  Silver coin building, Opp. Avabai Highschool, Halar road, Valsad
Valsad
GUJARAT 		 02632254303

drkanti.saroj@gmail.com 
Dr Nimish Bhavsar  Shahpur Medical Hospital  Opposite Chisti Chamber, O/S Shahpur Gate, Shahpur, Shahpur, Ahmedabad, Gujarat 380004
Ahmadabad
GUJARAT 		 07925627125

sarthihospital@hotmail.com 
Dr Jagdish Patel  Shantaba Hospital  26/A, Virnagar Society, Nava Vadaj Road, New Vadaj, Ahmedabad - 380013, Near Bhimjipura Cross Road
Ahmadabad
GUJARAT 		 07927561320

dr.jagdish1957@gmail.com 
Dr Pragnesh B vora  Shlok medical and hospital  Ground floor, suvandana apartment nr.yamunaji haveli maninagar isanpur road ahmedabad 380050
Ahmadabad
GUJARAT 		 9825865560

falgunipragnesh@yahoo.co.in 
Dr Balmukund S Shah  Shreeji Clinic and Nursing Home  GF - 111, 112, 113, 114 Palladium Bussiness Hub, Visat Gandhingar Highway, Opp. PVR Cinema, Motera, Ahmedabad - 380005,
Ahmadabad
GUJARAT 		 9825005084

bal_shah123@outlook.com 
Dr Bhavesh Patel  Shreeji Hospital  Saraswati Shopping Centre, Nr. Vishat Petrol Pump, ONGC,Opp. Avani Bhavan, Sabarmati, Ahmedabad-380005
Ahmadabad
GUJARAT 		 9824293802

gbpbhav@yahoo.com 
Dr Chirag Shah  Shreeji Multispeciality Hospital  Opp Bhagvatdham gurukul Main Road Dhrangadhra, Gujarat 363310 India
Surendranagar
GUJARAT 		 9879503844

chirag_shah51@hotmail.com 
Dr Rajesh Gheewala  Shubham Hospital  Opp. Sagarampura Police Chowky, Rajeshree Road, Surat- 395003
Surat
GUJARAT 		 9824475256

drrajeshgheewala@hotmail.com 
Dr Sachin Gupta  Shubham Hospital  Sharda Shopping Centre, Rabari Colony Char Rasta, Amraiwadi, Ahmedabad - 380026 Gujarat
Ahmadabad
GUJARAT 		 07925850145

stgupta@yahoo.com 
Dr Jamil Khanji  Sparsh Hospital  Modasa
Sabar Kantha
GUJARAT 		 9898616138

sparsh.modasa@gmail.com 
Dr Parshottamdas Dharamdas Premjani   Sushil Hospital  Mayur Kunj Society, V K V Road, Nadiad - 387001
Anand
GUJARAT 		 02682523777

drpremjani@yahoo.co.in 
Dr Viral Patel  Umiya Heart and Medical  137, Vardhaman Nagar, Near Sardar Baug, Kalol, Gandhinagar-Gujarat - 382721,
Gandhinagar
GUJARAT 		 02764222525

vvjv2009@yahoo.in 
Dr Nitin Patel  Utkarsh Hospital  Visnagar, Mehsana, Gujarat, India
Mahesana
GUJARAT 		 9909973915

nitp120165@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS- Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I209||Angina pectoris, unspecified, Male/Female patient with sign/symptoms of Angina Pectoris.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Patients with Normal Sinus Rhythm on ECG at Screening

2 Patients who have signed Written Informed Consent

3 Patients with stable/unstable or Prinzmetals angina for at least 3 months prior to inclusion (mild/moderate/severe)

4 Male or Female patients > 18 years and < 75 years of age.


 
 
ExclusionCriteria 
Details  1 Male or Female patients < 18 years and > 75 years of age
2 Congestive heart failure stage III or IV NYHA.
3 Symptomatic hypotension.

4 Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation
5 History of serious abnormal drug reaction.
6 Patients with Postural hypotension
7 Patients with chronic kidney failure
8 History of any serious infectious disease like Hepatitis B or C, HIV etc.
9 History of severe psychiatric or behavioral disorders likely to interfere with the study.
10 Patients with other severe disease likely to interfere with the study in the investigators judgment.
11 Pregnant and lactating women.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Objective

To assess efficacy of Tablet NGfenceTM by evaluating improvement in following parameter :

1) Frequency of anginal attack
2) Severity of anginal attack
3) Ability to perform physical activity

 		 At month 3 and month 6 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objectives

To assess tolerability of Tablet NGfenceTM by evaluating improvement in following parameter
1) Headache
2) Dizziness
3) Flushing
4) Vomiting
5) Nausea 		 At month 03 and month 06 
 
Target Sample Size   Total Sample Size="1365"
Sample Size from India="1365" 
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   N/A 
Date of First Enrollment (India)   01/11/2018 
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="0"
Months="10"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 observational study and does not include any interventional product or procedure. The purpose of this study is to evaluate safety and efficacy of tablet NGfenceTM in terms of find out frequency of headache, frequency of chest pain and improvement in quality of life. Total study duration is about 06 months.       
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