CTRI/2018/02/012101已完成3 期
A Randomized, Comparative, Open Clinical Trial for Evaluating the Efficacy of JLN/PP/108 Suspension in the Management of Functional Dyspepsia and Reflux Oesophagitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
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
- •Inclusion Criteria:-Functional (Non â??ulcer)Dyspepsia(NUD)
- •1 Subjects with 24% of dyspepsia as per the Hong Kong Index of Dyspepsia
- •2 Subjects with normal upper gastrointestinal endoscopy, absence of any clinical, or ultrasonographic evidence of organic disease that would account for the symptoms.
- •3 In the event of patient undergoing treatment for dyspepsia, washout period of 1 week was mandatory.
- •4 Willingness to sign informed consent and to come for regular follow- up examinations as & when required.
- •Inclusion Criteria:- Gastrointestinal Esophageal Reflux disorder(GERD)
- •5 Subjects suffering from Reflux oesophagitis.
- •6 Subjects complaining for more than 25 percent of the time like heartburn, regurgitation, for at least 1 month.
- •7 Subjects with Grade o and Grade I of GERD symptoms.
- •8 Subjects with gastrointestinal endoscopy positive and negative evidence.
- •9 Willingness to sign informed consent and to come for regular follow- up examinations as & when required.
排除标准
- •Exclusion Criteria:-Functional (Non â??ulcer)Dyspepsia(NUD
- •1 Subjects suffering from peptic and duodenal ulcers.
- •2 Family history of peptic ulcer disease or gastric malignancy.
- •3 Subjects suffering from Reflux oesophagitis.
- •4 Subjects with chronic NSAID and steroids ( > 1 month) use with or without evidence of an ulcer
- •5 Uncooperative Subjects or subjects not willing to sign Informed Consent or giving consent for study required procedure like endoscopy.
- •6 Subjects with clinically diagnosed serious medical illness (Diabetes, SLE, Rheumatoid Arthritis, Rheumatic Arthritis, Psoriatic Arthritis), surgical illness where compliance is difficult.
- •7 Subjects on any other medication for the treatment of acidity other than specified in the study.
- •8 Subjects not willing to follow up for the study visits.
- •9 Subjects with age range below 16 years and above 65 years; dyspepsia persisting for less than 1 month before endoscopy;
- •10 Clinical evidence of irritable bowel syndrome; prior gastric surgery or proven peptic ulceration in the past;
- •11 Subjects with history of upper G.I. bleeding;
- •12 Subjects with overwhelming physical or mental disease (this includes subjects with carcinoma, pancreatitis, gall bladder disease, acute and chronic liver disease, bowel obstruction, chronic diarrhea and major psychosis);
- •Exclusion Criteria:- Gastrointestinal Esophageal Reflux disorder(GERD)
- •13 Family history of peptic ulcer disease or gastric malignancy.
- •14 Subjects not giving consent for study required procedure like endoscopy.
- •15 Subjects with chronic NSAID use ( > 1month) with or without evidence of an ulcer.
- •16 Subjects not willing to sign Informed Consent.
- •17 Subjects with clinically diagnosed serious medical illness (Diabetes, SLE, Rheumatoid Arthritis, Rheumatic Arthritis, Psoriatic Arthritis), surgical illness where compliance is difficult.
- •18 Subjects on any other medication for the treatment of acidity other than specified in the study.
- •19 Subjects not willing to follow up for the study visits.
- •20 Patients meeting the above inclusion and exclusion criteria were made fully aware of the type of treatment given to them and then informed consent were taken.
研究者
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