Acupuncture and/or Diclectin Treatment for Nausea and Vomiting of Pregnancy: A Two by Two factorial Trial (NVPAct)

Not Applicable

• Conditions: Vomiting of Pregnancy

• Registration Number: ITMCTR2000003272
• Lead Sponsor: First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean difference in PUQE scores;

Secondary Outcome Measures

Name	Time	Method
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;