Vomiting of Pregnancy
Conditions
Interventions
Sponsors
First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 20 to 45 years; 2. Subjects who were pregnant for 7-14 weeks (49-98 days, calculated according to the last menstruation); 3. Subjects whose score of pregnancy nausea and vomiting scale >=6; 4. Subjects whose body weight is less than 20% of normal body weight at the early stage of pregnancy; 5. Subjects with pregnancy (singleton / multifetal) proved by ultrasound; 6. Subjects willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with major diseases, such as malignant tumor, acute or subacute hepatitis, severe aplastic anemia, idiopathic thrombocytopenic purpura, acute appendicitis, acute pancreatitis, torch syndrome; 2. Patients with chronic diseases, such as diabetes, coronary heart disease, and chronic hypertension; 3. Patients with other vomiting diseases, such as thyroid disease, gastroenteritis history, gastrointestinal disease, infectious disease, trophoblastic disease, psychological disorders, etc; 4. Patients with asthma, high intraocular pressure, narrow angle glaucoma, peptic ulcer, pyloric obstruction, bladder neck obstruction and other diseases; 5. Patients who use other antiemetics, such as vitamin B6, ondansetron, metoclopramide, prednisone, etc 6. Patients who are effective in conservative treatment (adjustment of diet and life style); 7. Patients with abnormal physical examination or laboratory examination; 8. Patients with mental disorders; 9. Patients who are allergic to doxyramine, other antihistamines, pyridoxine hydrochloride and any non active ingredients in diclicin; 10. Patients with monoamine oxidase (MAO) inhibitors; 11. The object of driving or operating heavy machinery; 12. Subjects who use alcohol or other central nervous system inhibitors such as diazepam, phenobarbital, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean difference in PUQE scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| study withdraw;Change in Visual analog scale;Use of other medications (not for NVP);change in NVPQOL;the day-by-day area under the curve for change in PUQE scores from baseline;side effects;mean difference in in Global assessment of well-being after treatment;the amount of Diclectin in each arm where women will continue use of site package medication during one month follow-up if symptoms persist;time loss from employment;The number of women in each group who reported concurrent use of other alternate therapy for NVP; | — |
Countries
China
Contacts
Public ContactXiaoke Wu
First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Outcome results
None listed