Health Condition 1: R109- Unspecified abdominal pain
Conditions
Interventions
Intervention1: Anafortan (Camylofin 50 mg and Paracetamol 325mg): TID for 5 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr Avinash Balekuduru
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in the age group of 18-65 years, with symptoms suggestive of acute abdominal colicky pain, and having at least one episode of colicky pain within 24 hours prior to visit, will be included in this study. 2. Subjects who are willing and able to provide written informed consent and comply with study procedures will be included in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with history of Known hypersensitivity to the study drugs/ any of study drugs ingredients. 2. Patients who had undergone coronary artery bypass graft surgery with epilepsy or inflammatory bowel disease will be excluded. 3. Patients with chronic abdominal pain such as Celiac disease, lactose intolerance, ulcerative colitis and Crohnâ??s disease. 4. Patients who may have narrow angle glaucoma, confirmed or suspected intestinal obstruction, Pregnancy and lactation, Urinary retention, Mega colon, GI hemorrhage, Tachyarrhythmia, Porphyria or Cancer, Severe hepatic impairment. 5. Patients with any other conditions or diseases that Investigator considers as ineligible to enroll in the study based on approved prescribing information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in the mean intensity of pain based on the 100mm VAS score from baseline to EOSTimepoint: Visit 3 (Day 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the frequency of daily pain episodes; Number and percentage of patients by Physician Global Assessment (PGA) and efficacy tolerability composite score; achieving more than 50% VAS reductionTimepoint: Visit 3 (Day 5) | — |
Countries
India
Contacts
Public ContactDr Somesh Bolegave
SIRO Clintech Pvt Ltd
Outcome results
None listed