CTRI/2017/06/008781CompletedPhase 2
A Randomized Double-Blind Placebo Controlled Clinical Study for the Evaluation of Efficacy and Tolerability of Zanacid Duo in patients suffering from Dyspepsia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Emami Limited
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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 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.
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.
Investigators
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