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Observation on Clinical Efficacy of Auricular Press-needle Combined with Vitamin B6 in the Treatment of Hyperemesis Gravidarum of Spleen-stomach Weakness Type

Observation on Clinical Efficacy of Auricular Press-needle Combined with Vitamin B6 in the Treatment of Hyperemesis Gravidarum of Spleen-stomach Weakness Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001455
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis Gravidarum

Interventions

Experimental group:The experimental group undergoes press-needle therapy on the basis of conventional fluid replacement treatment with vitamin B6.
Control group:The control group is given conventional fluid replacement treatment with vitamin B6.

Sponsors

Shenzhen Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Gestational age within 6-14 weeks with intrauterine singleton pregnancy confirmed by ultrasound examination; 2.Age between 20 years old (inclusive) and 40 years old (exclusive); 3.Conforming to the diagnostic criteria of hyperemesis gravidarum in Western medicine and "ezhu" (pernicious vomiting during pregnancy) in traditional Chinese medicine, with the TCM syndrome type being spleen-stomach weakness. 4.No acute or chronic diseases common obstetric comorbidities or complications; 5.No history of allergies to drugs or contact substances related to the research; 6.Having signed the informed consent form and voluntarily participating in accordance with the research design.

Exclusion criteria

Exclusion criteria: 1. Personnel who do not meet the inclusion criteria. 2. Those with severe cardiovascular and cerebrovascular diseases liver diseases kidney diseases malignant tumors hematopoietic system diseases and mental diseases. 3. Patients who are using multiple fetal protection drugs simultaneously in the early pregnancy for fetal protection. 4. Patients with a history of threatened abortion or spontaneous abortion. 5. Those with an allergic constitution those who are allergic to the drugs and consumables used in this trial and those with mental diseases or unclear consciousness. 6. Those who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Secondary

MeasureTime frame
Pregnancy-Unique Quantification of Emesis and nausea;Traditional Chinese Medicine Syndrome Score Scale;Na+;K+;urine ketone;

Countries

China

Contacts

Public ContactJiaman Wu

Shenzhen Maternity and Child Healthcare Hospital

wujiaman202@163.com15817470407

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026