Health Condition 1: null- patients with acute infectious diarrhoea
Conditions
Interventions
Intervention1: 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 i
Sponsors
Walter Bushnell Pvt Ltd
Eligibility
Inclusion criteria
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 50 mm and â??moderate to severeâ?? 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)]. Timepoint: 30 minutes, 45 minutes and 60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 3 days | — |
Countries
India
Contacts
Public ContactDR Shiva Narang
University College of Medical Sciences and Guru Teg Bahadur hospital
Outcome results
None listed