Effects of Chinese Medicine on Early Pregnant Women | NCT04848571

Studies
Effects of Chinese Medicine on Early Pregnant Women

NCT04848571

Sponsor

Shanghai Meiji Health Science and Technology Co., Ltd.

Status

Completed

Last Update Posted

Jun 17, 2025Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Pregnant Women

Interventions

Fetal Protection Pill

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Nov 2, 2021Actual

First Submitted Date

Apr 7, 2021

First Submission Date that Met QC Criteria

Apr 13, 2021

First Posted Date

Apr 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2025

Last Update Posted Date

Jun 17, 2025Actual

Name	Class
Shanghai Institute of Palnned parenthood research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

From April 2021 to December 2021, 45 pregnant women who received intro fertilization-embyro transfer (IVF-ET) were recuited. According to their own wishes, 28 of them took Chinese medicine from the 2nd week after embryo transfer (intervention group), while the remaining 17 did not intake Chinese medicine (control group). Blood and feces samples were collected in the early morning of the 4th week after embryo transfer to detect 16S DNA sequences in feces, plasma metabolites, and whole blood transcriptomics.

Detailed Description

Investigators planned to performed a observational clinical trial to determine the effects of the Chinese medicine (Gushen Antai recipe) including mainly Rehmannia glutinosa used in pregnant women for fetal protection. Two groupswere recruited, Chinese medicine intervention group and control group without Chinese medicine. In the 4th week after embryo transfer, blood and fetal were sampled for metabolic and intestinal microbiota analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		Pregnant women who received IVF and not taken Chinesene fetal protection medicine until sampling
medicine group		Pregnant women who received IVF and have taken Chinesene fetal protection medicine from the fourth week during early pregnancy	Combination Product: Fetal Protection Pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fetal Protection Pill	Combination Product	A Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa.	medicine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
16s DNA analysis in feces	intestinal flora analysis in patients	the fourth week in early pregnancy

Secondary Outcomes

Measure	Description	Time Frame
plasma metabonomics analysis by GC/LC mass	plasma metabolic analysis in patients	the fourth week in early pregnancy

Other Outcomes

Measure	Description	Time Frame
whole blood transcriptomics analysis by RNA sequencing	blood transcriptomic analysis in patients	the fourth week in early pregnancy

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

17 patients in contol group and 28 patients in the Chinaese medicine intervention group

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enuo Liu, Dr.	Shanghai Institute of Planned Parenthood Research	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided