Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy

PHASE3CompletedINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

June 21, 2020

Primary Completion Date

June 23, 2021

Study Completion Date

January 31, 2022

Conditions
Nausea and Vomiting of Pregnancy
Interventions
DRUG

Diclectin

Diclectin (combination of 10 mg doxylamine and 10 mg pyridoxine hydrochloride in a delayed release tablet) During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of Diclectin or placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.

DRUG

Diclectin placebo

Diclectin placebo will be packed and tested by a commercial pharmacy supply company specifically for this study. It have the same appearance, size, batch, odor, and taste compared with Diclectin. During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.

DEVICE

Active acupuncture

Participants will receive active acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).

DEVICE

Sham acupuncture

Blunt-tipped placebo needles will be used. Participants will receive sham acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6). Then, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).

Trial Locations (13)

Unknown

First Affiliated Hospital of Heilongjiang Chinese Medicine University, Harbin

Heilongjiang provincial hospital, Harbin

Hegang Maternal and Child Health Hospital, Hegang

Affiliated Hospital of Jiamusi Medical University, Jiamusi

Jiamusi Maternal and Child Health Hospital, Jiamusi

Jixi Maternal and Child Health Hospital, Jixi

Mudanjaing Maternal and Child Health Hospital, Mudanjiang

Shuangyashan Maternal and Child Health Hospital, Shuangyashan

Suihua Maternal and Child Health Hospital, Suihua

Luoyang Hospital of TCM, Luoyang

Xuzhou Central Hospital, Xuzhou

Jiangxi Maternal and Child Health Hospital, Nanchang

Ningxia Hui Autonomous Region Hospital of TCM, Yinchuan

All Listed Sponsors
collaborator

Ningxia Hui Autonomous Region Hospital of TCM

UNKNOWN

collaborator

Jiangxi Maternal and Child Health Hospital

OTHER

collaborator

Jixi Maternal and Child Health Hospital

UNKNOWN

collaborator

Luoyang Hospital of TCM

UNKNOWN

collaborator

Xuzhou Central Hospital

OTHER

collaborator

First Affiliated Hospital of Heilongjiang Chinese Medicine University

OTHER

collaborator

Shuangyashan Maternal and Child Health Hospital

UNKNOWN

collaborator

Heilongjiang provincial hospital

UNKNOWN

collaborator

Jiamusi Maternal and Child Health Hospital

UNKNOWN

collaborator

Hegang Maternal and Child Health Hospital

UNKNOWN

collaborator

Suihua Maternal and Child Health Hospital

UNKNOWN

collaborator

Mudanjaing Maternal and Child Health Hospital

UNKNOWN

collaborator

Affiliated Hospital of Jiamusi Medical University

UNKNOWN

lead

Xiaoke Wu

OTHER

NCT04401384 - Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy | Biotech Hunter | Biotech Hunter