临床试验/CTRI/2015/09/006148

CTRI/2015/09/006148已完成不适用

A randomized, double blind, placebo controlled, parallel group, single center study to evaluate the safety and efficacy of DigeZymeÂ® in patients with non ulcer functional dyspepsia and delayed onset muscle soreness (DOMS)

Sami labs Limited1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2015年2月9日最近更新: 2020年10月9日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 40
试验地点: 1
主要终点: 3 Visual Analog Scale

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A randomized, double blind, placebo controlled, parallel group, single center study to evaluate the safety and efficacy of DigeZyme in patients with non ulcer functional dyspepsia and delayed onset muscle soreness. The study will be conducted in two parts - Part 1 and Part 2. The efficacy outcomes for Part 1 will include Short form of Leeds Dyspepsia Questionnaire, Nepean Dyspepsia Index, Visual Analog Scale, Clinical Global Impression and Glasgow Dyspepsia Severity Score. After a week wash out period from the last day of follow up visit of Part 1, subjects who are interested to participate in 72 hours delayed onset muscle soreness will be enrolled. The efficacy outcomes for Part 2 will include Muscle Soreness questionnaire, Algometer assessment, hand held dynamometer, Agility run test and Serum markers. The individual subject involvement for Part 1 will be 60 days while that for Part 2 will be 3 days. All adverse events will be recorded.

研究设计

研究类型: Interventional
分配方式: Other
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•1 Male or female subjects ranging in age from 18 to 75 years (both inclusive) diagnosed as having gastro intestinal disorders by the Investigator 2 Athletes or sports persons with functional dyspepsia 3 Fulfilling Rome III Diagnostic Criteria for Functional Dyspepsia Diagnostic criteria Must include-One or more of the following a Bothersome postprandial fullness b Early satiation c Epigastric pain d Epigastric burning AND No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis 4 Willingness to follow the protocol requirement as evidenced by written, informed consent 5 Willingness to complete study questionnaires 6 Agree not to use any medication prescription and over the counter, including vitamins and minerals, during the course of this study 7 Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range 8 Subjectâ€™s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study.

排除标准

•1 Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol 2 Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry 3 Organic gastrointestinal or systemic diseases 4 Diabetes mellitus and cardiovascular problems 5 Volunteers on any other enzyme inhibiting drugs whose primary target is in the GI 6 Use of drugs that interfere with gastrointestinal motility 7 History of hypersensitivity reactions 8 History or presence of significant alcoholism or drug abuse in the past one year 9 Participation in a clinical study during the preceding 90 days 10 Previous abdominal surgery (except appendectomy) 11 Any contraindication to blood sampling 12 Smoking or consumption of tobacco products 13 Blood or blood products donated in past 30 days prior to study supplement administration 14 Female subjects on pregnancy and lactating women 15 Volunteers on any concomitant therapy like homeopathy, ayurvedic etc.

结局指标

主要结局

3 Visual Analog Scale

Part 1

1 SF-LDQ

4 Clinical Global Impression

2 NDIâ€“SF

5 Glasgow Dyspepsia Severity Score

Part 2

1 MSQ and Algometer

2 Serum markers

3 Hand held dynamometer

4 Agility run test

次要结局

Part 1(1 Adverse Events)

研究者

发起方

Sami labs Limited

申办方类型

Other [Marketer and manufacturer of phytonutrients, ayurvedic, herbal extracts, probiotics etc.]

研究点 (1)

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