352
Participants
Start Date
June 21, 2020
Primary Completion Date
June 23, 2021
Study Completion Date
January 31, 2022
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.
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.
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).
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).
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
Ningxia Hui Autonomous Region Hospital of TCM
UNKNOWN
Jiangxi Maternal and Child Health Hospital
OTHER
Jixi Maternal and Child Health Hospital
UNKNOWN
Luoyang Hospital of TCM
UNKNOWN
Xuzhou Central Hospital
OTHER
First Affiliated Hospital of Heilongjiang Chinese Medicine University
OTHER
Shuangyashan Maternal and Child Health Hospital
UNKNOWN
Heilongjiang provincial hospital
UNKNOWN
Jiamusi Maternal and Child Health Hospital
UNKNOWN
Hegang Maternal and Child Health Hospital
UNKNOWN
Suihua Maternal and Child Health Hospital
UNKNOWN
Mudanjaing Maternal and Child Health Hospital
UNKNOWN
Affiliated Hospital of Jiamusi Medical University
UNKNOWN
Xiaoke Wu
OTHER