Health Condition 1: K297- Gastritis, unspecified
Conditions
Interventions
Intervention1: Gastroplex® Syrup. Each 5 mL of Gastroplex® Syrup contains:
Carica Papaya Q HPI 0.15 ml, Hydrastis Canadensis Q HPI 0.05 ml, Belladonna Q HPI 0.05 ml, Iris Versicolor Q HPI 0.05 ml, L
Sponsors
Powell Laboratories (P) Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to any study specific procedures being performed. 2. Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based on the date of the Screening visit. 3. Subjects with symptoms of pain in abdomen, epigastric burning, Nausea and vomiting, and early satiety, Suggestive of acute or chronic gastritis. 4. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Exclusion criteria
Exclusion criteria: 1) Pregnant and Lactating Female 2) Body mass index >35 kg/m2 3) Reports a history of allergic response(s) to the active ingredient or to any of the excipients of the Investigational Medicinal product. 4) Reports history of Gastric Ulcer, Duodenal Ulcer. 5) Reports history of Haemetaemesis, Melaena and Anaemia 6) Reports any presence or history of Gastric Carcinoma. 7) Reports history of Zollinger-Ellison syndrome 8) Active alcohol or drug abuse that would interfere with study participation. 9) Reports a history of drug or alcohol addiction or abuse within the past 1 year. 10) Reportâ??s history of Major surgery to the gastrointestinal tract, liver, or kidney within 3 months prior to study entry which may affect the pharmacokinetics of the Study drug. 11) Reports a history of allergic asthma 12) Reportâ??s organ or tissue transplant 13) Reports history of psychiatric disorders including eating disorders. 14) Reports history of esophageal varix (varices) 15) Reports autoimmune disorder (e.g., lupus, rheumatoid arthritis, multiple sclerosis, etc.) 16) Participants administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins, or mucosal protective agents prior to study in 1 week. 17) Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the investigator(s). 18) Known history of hepatitis B and/or Hepatitis C virus. 19) History of HIV or any immune deficient conditions. 20) Able to understand aims and constraints of study and complete self-evaluation Subject diary 21) Reportâ??s history of participation in another clinical study within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients reporting Improvement in symptoms of pain in abdomen, epigastric burning, Nausea and vomiting, and early satiety based on subjective and objective parameters (The Visual Analogue Scale (VAS)) 2. Improvement in the Gastrointestinal Quality of Life Index before and after the treatment.Timepoint: Week 2 (± 3 days) and Week 4 (± 3 days-end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern, and causal relationship to the study medication. 2. Changes in Laboratory Safety Parameters (Hematology, and Serum Biochemistry analysis) from baseline to end of the study. (Only If reports are available) 3. Changes in Vital Signs from baseline to end of the study. 4. Treatment Compliance (Treatment compliance will be assessed using a subject diary.)Timepoint: Week 2 (± 3 days) and Week 4 (± 3 days-end of treatment) | — |
Countries
India
Contacts
Public ContactPravinkumar Pal
CLINICA Research Solutions LLP
Outcome results
None listed