Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
None listed
Sponsors
Nutrin GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Gender: Non-pregnant, non-lactating female aged between 18 to 65. 2.Subject willing to give written informed consent 3.Women of child bearing potential must have a negative urine pregnancy test. 4.Free of any Kidney and Heart disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
Exclusion criteria
Exclusion criteria: 1.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study. 2.Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product. 3.Have participated in any interventional clinical trial in the previous 30 days. 4.Have a known sensitivity to sorbitol and any of the constituents of the test product. 5.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years. 6.Patients with Cholecystectomy. 7.Subject with an elevated level of calcium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SGA self-evaluation score Change in RDQ scoreTimepoint: Time frame 0-1 day Time frame 0-1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactPuneet Mittal
Mittal Global Clinical Trial Services
Outcome results
None listed