Health Condition 1: - Health Condition 2: K639- Disease of intestine, unspecified
Conditions
Interventions
Intervention1: Bismozyme oral liquid: Bismozyme oral liquid.Dose
10 mL twice a day. Indication
nausea vomiting fullness loss of appetite bloating
abdominal pain heartburn food regurgitation and acid
Sponsors
Eastern Drug
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male & female volunteers, with age between 18-65 years. 2. Participants identifying their main symptoms as nausea, vomiting, fullness, loss of appetite, bloating, abdominal pain, heartburn, food regurgitation and acid or sour taste in mouth associated with gastrointestinal motility disorders, etc. for minimum one month. 3. Willing to give written informed consent. 4. Patients willing to and able to comply with all trial requirements. 5. Patients who have not participated in a similar clinical trial in the past four weeks. 6. Female patients with child bearing potential must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study 7. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion criteria
Exclusion criteria: 1.Patients with a known history of Barretts esophagus during screening endoscopy. 2.Patients with acute upper gastrointestinal bleeding, gastric ulcer within 30 days before the start of the Screening Visit. 3.Patients requiring chronic use of nonsteroidal anti inflammatory drugs NSAIDs including cyclooxygenase 2 COX2 NSAIDs within 30 days prior to the Screening Period and throughout the study. 4.Has comorbidities that could affect the esophagus a history of radiotherapy or cryotherapy of the esophagus and a history of corrosive or physiochemical injury 5.Patients with a history of surgical procedures that may affect the esophagus or a history of gastric or duodenal surgery other than endoscopic removal of benign polyps. 6.Patients with erosive esophagitis as shown by endoscopy, during the screening period 7.Patients with diabetes mellitus requiring treatment 8.Patients with history of IBS 9.Patients with serious anxiety disorder 10.Patients with depression and or sleep disorder 11.Patients with biliary tract disease and or pancreatitis 12.Patients with presence of any symptom indicating serious or malignant disease. 13.Patients with the current past infections such as tuberculosis, herpes and or patients with immune system disorders like HIV and SLE or hepatitis including hepatitis virus carriers 14.Abnormality in the electrocardiogram at rest 15.Patients having allergy or sensitivity to study drugs and excipients in the formulation. 16.Participating in a clinical research trial within 30 days prior to screening. 17.Any other health or mental condition that in the Investigators opinion may adversely affect the patientâ??s ability to complete the study 18.Female patients who are pregnant breast feeding nursing or planning to become pregnant during study participation or did not agree to use an acceptable form of birth control throughout the study. 19.Patients with current or historical evidence of Zollinger Ellison syndrome or a history of gastric acid hypersecretion. 20.Patients scheduled for surgery that requires hospitalization or requires surgical treatment during his her participation in the study. 21. Patients who have donated or lost 300 milliliter mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug. 22.Patients with a history of alcohol abuse or drug addiction in the 12 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Assessment of safety of the formulation with respect to adverse events and change in clinical laboratory parametersTimepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in frequency and severity of following symptoms : nausea, vomiting, fullness, loss of appetite, bloating, abdominal pain, heartburn, food regurgitation and acid or sour taste in mouth pre and post therapy in percentage Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
PRORELIX SERVICES LLP
Outcome results
None listed