A clinical study to assess efficacy and safety of Zanacid Duo in patient suffering from dyspepsia.
- Conditions
- Health Condition 1: null- Patients Suffering from Dyspepsia
- Registration Number
- CTRI/2017/06/008781
- Lead Sponsor
- Emami Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
• 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 â?? 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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