Ongoing Clinical Trials for Morning Sickness
There is currently 1 ongoing clinical trial focused on treatment options for morning sickness (Also known as: Nausea and Vomiting of Pregnancy). This trial is investigating a combination medication to help improve quality of life for pregnant women experiencing these common symptoms.
Clinical trial locations
Study on Doxylamine and Pyridoxine for Pregnant Women with Nausea and Vomiting
This clinical trial is evaluating a combination medication to help pregnant women manage nausea and vomiting during early pregnancy. The treatment being studied contains doxylamine (an antihistamine) and pyridoxine (vitamin B6) in a specially designed capsule that releases the medication slowly over time.
Who can participate? Women can join this study if they meet the following criteria:
- Pregnant women aged between 18 and 45 years
- Between 5 and 12 weeks of pregnancy, confirmed by ultrasound
- Experiencing nausea and vomiting with a severity score of 6 or higher on the PUQE scale
- No plans to end the pregnancy
- Willing to follow medication instructions and attend all study visits
- Not previously taken this combination medication, or taken no more than 20/20 mg daily dose in the 5 days before joining
Who cannot participate? Women are excluded from this study if they:
- Are not pregnant or not experiencing pregnancy-related nausea and vomiting
- Fall outside the specified age range
- Have medical conditions that might interfere with the study
- Are taking medications that could interact with the study treatment
- Have allergies to doxylamine, pyridoxine, or any ingredients in the study medication
- Are unable to follow the study procedures
What is the focus of the trial? The main goal of this study is to evaluate how this combination treatment affects quality of life for pregnant women dealing with nausea and vomiting. Participants will take the medication for 14 days, with evaluations at 7 days and 14 days to assess improvements in symptoms. The researchers will monitor how quickly the treatment works, its effect on the frequency and severity of symptoms, and overall patient satisfaction with the treatment. Safety is also carefully monitored throughout the study by tracking any side effects.
The medication is taken orally in capsule form, with dosing that can be adjusted based on how well symptoms respond to treatment. The dosing schedule may range from 2 capsules at night initially, up to a maximum of 4 capsules daily (taken morning, afternoon, and night) depending on individual needs.
Investigational medications: The trial uses a fixed-dose combination of doxylamine hydrogen succinate and pyridoxine hydrochloride, each at 10 mg per capsule. Doxylamine works by blocking histamine receptors in the body, which helps reduce nausea. Pyridoxine, a form of vitamin B6, supports metabolic processes that may help alleviate nausea and vomiting symptoms.
Summary
Currently, there is one active clinical trial addressing morning sickness, taking place in Spain. This trial focuses on evaluating a combination of doxylamine and pyridoxine for improving quality of life in pregnant women experiencing nausea and vomiting during early pregnancy. The study is designed to assess both the effectiveness of the treatment in reducing symptoms and its safety profile over a two-week treatment period. Women who are in their first trimester and experiencing moderate to severe symptoms may be eligible to participate in this research.