CTRI/2020/08/027027已完成4 期
A RANDOMIZED, DOUBLE BLIND, PARALLEL DESIGN, PLACEBO CONTROLLED PHASE IV STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BISMOZYME (NUX VOMICA, ALUMINIUM CITRATE, BISMUTH CITRATE, DILL OIL, CHLOROFORM) IN PATIENTS WITH SYMPTOMATIC GASTROINTESTINAL MOTILITY DISORDER
Eastern Drug0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
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