Effects of Chinese Medicine on Early Pregnant Women

Pregnant Women Clinical Trial

Official title:

Effects of Chinese Medicine on Early Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848571
• Other study ID #: sippr
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: November 2, 2021

Study information

• Verified date: May 2024
• Source: Shanghai Meiji Health Science and Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

From April 2021 to December 2021, 50 pregnant women who received intro fertilization (IVF) will be recuited. Among them, 25 of them would like to take Chinese medicine from the 2nd week after embryo transfer (intervention group), while the remaining 25 will not intake Chinese medicine (control group). Blood and feces samples will be collected in the early morning of the 4th and 6th week after embryo transfer to detect 16S DNA sequences in feces, plasma metabolites, and whole blood transcriptomics.

Description:

Investigators planned to performed a randomized trial to determine the effects of the Chinese medicine (Bushen Antai recipe) including mainly Rehmannia glutinosa used in pregnant women for fetal protection. Two groups will be recruited, Chinese medicine intervention group and control group without Chinese medicine. In the 4th and 6th week after embryo transfer, blood and fetal are sampling for metabolic and intestinal microbiota analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 2, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• recieved IVF

• childbirth without miscarriage

• taking vitamins during pregnancy

Exclusion Criteria:

• miscarrige

• missed sampling in the fourth week of pregnancy

• not appropriate judged by the doctor

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Combination Product:
• Fetal Protection Pill
A Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa.

Locations

Country	Name	City	State
China	Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Meiji Health Science and Technology Co., Ltd.	Shanghai Institute of Palnned parenthood research

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	whole blood transcriptomics analysis by RNA sequencing	blood transcriptomic analysis in patients	the fourth week in early pregnancy
Primary	16s DNA analysis in feces	intestinal flora analysis in patients	the fourth week in early pregnancy
Secondary	plasma metabonomics analysis by GC/LC mass	plasma metabolic analysis in patients	the fourth week in early pregnancy