Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT05624034
Eligibility Criteria:
Inclusion Criteria:
* Subjects must meet the following criteria to be included in the study:
* Healthy subjects 20 Males and 20 females subjects atleast one will be taken from each group \[18-20,20-30,30-40,40-50,50-60,60-70yrsAbsence of previous upper gastrointestinal surgery anytime in past.
* Absence of drugs which affect the upper gastrointestinal system in 3 months.
* Absence of diabetes,thyroid disorder or neuromuscular disorder.
* Subject who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
* Subject willing to use appropriate method of contraception as per investigator's discretion, throughout the study
* Idiopathic Gastroparesis
* Male and female subjects above 18 to 70 years of age.
* Subject who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
* Subject willing to use appropriate method of contraception as per investigator's discretion, throughout the study
* Patient's having symptoms of dyspepsia based on ROME IV Criteria and not having a known cause of gastroparesis like endocrine, neurological, rheumatological disorder.
* ROME IV criteria for Functional Dyspepsia\* (Diagnostic criteria\*\*): One or more of the following
* Bothersome postprandial fullness
* Bothersome early satiation
* Bothersome epigastric pain
* Bothersome epigastric burning AND
* No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
-\*Must fulfill criteria for Postprandial Distress Syndrome (PDS) and/or Epigastric Pain Syndrome (EPS)
-\*\*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
* Diabetic Gastroparesis
* Male and female subjects above 18 to 70 years of age.
* Subject who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
* Subject willing to use appropriate method of contraception as per investigator's discretion, throughout the study
* Patient's having symptoms of dyspepsia based on ROME IV Criteria and Diabetes mellitus of any duration
Exclusion Criteria:
* Subjects who meet any of the following criteria will be excluded from the study:
* For Idiopathic Gastroparesis
* Subjects suffering from Diabetes
* Subjects with history of any bariatric procedures/ gastric surgeries in the past
* Females who are pregnant
* Subjects taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids, L-Dopa
* Subjects with electrolyte abnormalities like hypokalaemia, hypomagnesemia
* Subjects with known cases of thyroid disorder (hypo or hyperthyroidism)
* Subjects who are unsuitable for any other reason to participate in the study in the opinion of the investigator
* For Diabetic Gastroparesis
* Subjects with history of any bariatric procedures/ gastric surgeries in the past
* Females who are pregnant
* Subjects taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids, L-Dopa
* Subjects with electrolyte abnormalities like hypokalaemia, hypomagnesemia
* Subjects with known cases of thyroid disorder (hypo or hyperthyroidism)
* Subjects who are unsuitable for any other reason to participate in the study in the opinion of the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05624034
Study Brief:
Protocol Section:
NCT05624034