A study to determine efficacy of drotaverine and paracetamol combination in reducing abdominal pain due to diarrhea.

Phase 4

Completed

• Conditions: patients with acute infectious diarrhoea

• Registration Number: CTRI/2017/05/008449
• Lead Sponsor: Walter Bushnell Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-11
• Last Update Posted: 2017-02-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean pain intensity difference (PID) assessed by VAS at 60 minutes after administration of study medication.	30 minutes, 45 minutes and 60 minutes
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University College Medical Sciences and Guru Teg Bahadur hospital; 🇮🇳 East, DELHI, India

University College Medical Sciences and Guru Teg Bahadur hospital

🇮🇳East, DELHI, India

Dr Shiva Narang

Principal investigator

9868399612

shivanarang@gmail.com