Health Condition 1: null- Patients Suffering from Dyspepsia
Conditions
Interventions
Intervention1: Zanacid Duo: Dose: 1 Tablet twice daily
Duration: 45 days
Route: Oral
Control Intervention1: Placebo: Dose: 1 Tablet twice daily
Duration: 45 days
Route: Oral
Sponsors
Emami Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female subjects from the age of 18 years to 65 years. • Subjects with any of the four confirmed symptoms of Dyspepsia - upper abdominal fullness, epigastric pain, belching, bloating, early satiety, nausea, vomiting, regurgitation, heart burn and loss of appetite. • Subjects with the history of NSAID – induced ulceration. • Subjects with no contraindications or precautionary circumstances for participating in the trial as confirmed by the participating Investigators. • Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. • Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) during the entire trial. • Willing to sign the informed consent and comply with study procedure.
Exclusion criteria
Exclusion criteria: • Subjects with severe cases of gastric ulcer and gastro-intestinal related disorders / abnormalities. • Subjects with any acute or congenital illness. • Subjects with history of Renal Calculi or Cholelithiasis will be avoided. • Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders. • Subject has known allergic or has a suspected hypersensitivity to herbal products. • Expectation of any surgery during the study duration period. • Female subjects, who are pregnant, breast feeding or planning to become pregnant. • Subjects with any sign or symptom or systemic dysfunction, especially of the central nervous system. • History of congestive heart failure or any vascular conditions. • Subjects with HIV Positive status. • Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. • High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). • History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. • Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit. • Subjects taking Ayurvedic/Herbal/Natural medicines for such ailments within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the treatment period in Gastro -intestinal severity score through Global Over-all Symptoms (GOS)Timepoint: Day 1, Day 15th and Day 45th | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the treatment period in safety parameters through blood tests (RBS, CBC, Liver Function Tests, Renal Functional Tests and Urinalysis-routine).Timepoint: Day 1, Day 15th and Day 45th | — |
Countries
India
Contacts
Public ContactShekhar Gupta
EMAMI LIMITED
Outcome results
None listed