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 Limited0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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
•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

•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

发起方

Sami labs Limited