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CTRI Number  CTRI/2017/05/008449 [Registered on: 02/05/2017] Trial Registered Retrospectively
Last Modified On: 02/05/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to determine efficacy of drotaverine and paracetamol combination in reducing abdominal pain due to diarrhea. 
Scientific Title of Study   Efficacy and safety of fixed dose combination of drotaverine hydrochloride(80 mg)and paracetamol(500 mg) in amelioration of abdominal pain in acute infectious gastroenteritis: a double blind randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Shiva Narang 
Designation  Associate Professor Medicine 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur hospital 
Address  Department of Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden
Department of Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden
North East
DELHI
110095
India 
Phone  9899838807  
Fax    
Email  shivanarang@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Shiva Narang 
Designation  Associate Professor Medicine 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur hospital 
Address  Department of Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden
Department of Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden

DELHI
110095
India 
Phone  9899838807  
Fax    
Email  shivanarang@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Shiva Narang 
Designation  Associate Professor Medicine 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur hospital 
Address  Department of Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden
Department of Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden

DELHI
110095
India 
Phone  9899838807  
Fax    
Email  shivanarang@gmail.com  
 
Source of Monetary or Material Support  
Walter Bushnell Pvt Ltd Appejay Stya House, 14-Commercial Complex, Masjid Moth, Greater Kailash-II New delhi-110048  
 
Primary Sponsor  
Name  Walter Bushnell Pvt Ltd 
Address  Apeejay Stya House 14 Commercial Complex Masjid Moth Greater Kailash -2 New Delhi-110048 
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 Shiva Narang  University College Medical Sciences and Guru Teg Bahadur hospital  Department of Medicine University College of Medical Sciences and Guru Teg Bahadur HospitaL Dilshad Garden Delhi 110095
North East
DELHI 		 9868399612

shivanarang@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
academic and ethical committee,guru teg bahadur hospital,govt of NCT of delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with acute infectious diarrhoea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed Dose Combination of Drotaverine Hydrochloride (80 mg) and Paracetamol (500 mg)   Fixed Dose Combination of Drotaverine Hydrochloride (80 mg) and Paracetamol (500 mg) will be used in one arm at dose of three divided doses for 3 days 
Comparator Agent  Paracetamol (500 mg)   Paracetamol (500 mg) will be used in other arm at dose of three times per day for three days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1. Patients between 18 to 59 years of either gender with presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft, stools accompanied by symptoms within 24 hours preceding randomization with duration of illness ≤ 72 hours) who present with moderate to severe (baseline pain intensity [PI] score on a 100-mm visual analog scale [VAS] of > 50 mm and “moderate to severe” on a VRS scale) abdominal pain present at enrollment.
2. Patients who give written informed consent with videography prior to the study entry.
3. Patients with good health as determined by:
• Medical history
• Physical examination
• Clinical judgment of the investigator
 
 
ExclusionCriteria 
Details  1. Patients with moderate or severe dehydration requiring hospitalization and administration of intravenous medications.
2. Patients with bloody diarrhoea and dysentery.
3. Any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, or gastroduodenal perforation.
4. Concomitant use of medications that are known to increase the likelihood of upper gastrointestinal adverse events (e.g. corticosteroids and anticoagulants).
5. Patients with other established etiologies as pancreatitis, inflammatory bowel disease (IBD) or irritable bowel disease (IBS), previous gastrointestinal surgery and known immunodeficiency.
6. Patients with history of hypersensitivity to paracetamol and/or drotaverine.
7. Patients taking opioid analgesics, NSAIDs, and sedatives in the last 24 hours.
8. Presence of serious co-morbidity, such as cardiovascular disease, cerebrovascular disease, renal or hepatic impairment, diabetes, hypertension, hypo or hyperthyroidism.
9. Pregnant & lactating women.
10. Patients participating in any other clinical trial.
 
 
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 
Mean pain intensity difference (PID) assessed by VAS at 60 minutes after administration of study medication.
2. PI assessed through VAS scores/ Total pain relief (TOTPAR), the summed, time-weighted pain relief ar 2 h using both VAS and VRS data [TOTPAR 2 (VAS) and TOTPAR 2 (VRS)].
 		 30 minutes, 45 minutes and 60 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of pain relief (Onset of pain relief will be defined as pain relief score or PID of less than 30 for 30 minutes with VAS; pain relief score or pain intensity difference of 1 on VRS).
2. Number of episodes of pain/spasm, stool frequency and vomiting during 3 days of use of drug.
3. Overall clinical evaluation of response of therapy to be scored by patient and clinician separately at day 3 of follow up.
4. Occurrence of adverse effects.
 		 3 days 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/11/2015 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will be done in adults between ages of 18-59 years. Participants will either receive combination of drotaverine hydrochloride and paracetamol or only paracetamol  for three days. Participants will be evaluated at time of enrolment and then after first dose  of drug for 120 minutes to assess abdominal pain relief .Follow up shall be after three days. All adverse events will be recorded.Results have not been finalised yet as recruitment has just completed and data is being processed.
 
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