Effectiveness and safety of Formulation HB01 for instant relief from heartburn.
- Conditions
- Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
- Registration Number
- CTRI/2023/10/058553
- Lead Sponsor
- utrin GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method