Health Condition 1: R11- Nausea and vomiting
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Olene Life Sciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Given written informed consent to participate in the study. Participants aged 18 to 75 years. Willing to comply with all the requirements of this study protocol. Patients having treated with GLP-1 RAs agonist class of drugs. Receiving stable doses of GLP-1 RAs for at least 4 weeks prior to screening. Moderate-to-severe nausea or vomiting as defined by a score of greater than or equal to 3 on the Patient-Reported Nausea and Vomiting Severity (NVSA) scale. The participant is judged to be in good health based on medical history, physical examination and laboratory tests. Written informed consent signed by the subject, indicating willingness to comply with the study procedure. Individuals who smoke, consume alcohol, or use drugs are not eligible for this study.
Exclusion criteria
Exclusion criteria: History of gastrointestinal disorders unrelated to GLP-1 RAs. Use of antiemetic medications within 2 weeks prior to screening. The subject is taking supplementary vitamin B6 in addition to any multivitamin preparation or plans to do so during the study e.g., total vitamin B6 greater than 10 mg. Significant renal or hepatic impairment. The subject has a medical condition resulting in gastrointestinal malabsorption, such as celiac disease, Crohn disease, and ulcerative colitis i.e., may result in low or deficient levels of vitamin B6. The participant is currently drinking any amount of alcohol or taking illicit drugs like heroin, cocaine, methamphetamine etc. Pregnant or lactating women. Known hypersensitivity to the investigational product. The subject is likely to be unable to comply with study procedures because of inadequate cognitive or language skills. The subject has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study. Women refusing to avoid sources of ginger products for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in NVSA Scale from baseline to week 12. Timepoint: Screening visit and Enrollment Visit. Visit 01(Day 01):Baseline. Visit 02(Day 07):Follow-up Visit 01. Visit 03(Day 14):Follow-up Visit 02. Visit 04(Day 28):Follow-up Visit 03. Visit 05(Day 56):Follow-up Visit 04. Visit 06(Day 84):End of Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients discontinuing GLP-1 RAs due to Nausea/Vomiting. Incidence of adverse events.Timepoint: Screening visit & Enrollment Visit. Visit 01(Day 01):Baseline. Visit 02(Day 07):Follow-up Visit 01. Visit 03(Day 14):Follow-up Visit 02. Visit 04(Day 28):Follow-up Visit 03. Visit 05(Day 56):Follow-up Visit 04. Visit 06(Day 84):End of Visit. | — |
Countries
India
Contacts
Public ContactDr Giriraja KV MD
Rajalakshmi Hospital and Research Centre
Outcome results
None listed