Intrahepatic cholestasis of pregnancy (ICP)
Conditions
Interventions
Treatment Group ?:Ursodeoxycholic Acid Capsules + S-adenosylmethionine (SAMe) combination therapy.
Treatment Group ?:Acupuncture point needling therapy in Traditional Chinese Medicine.
Treatment Group ?:Acupuncture point needling therapy in Traditional Chinese Medicine (TCM) combined with Western medicine therapy.
Sponsors
Wansheng Economic and Technological Development Zone People's Hospital, Chongqing, China
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the Western diagnostic criteria for ICP (elevated maternal fasting serum total bile acids (TBA) =10 µmol/L or non-fasting TBA =19 µmol/L, accompanied by unexplained pruritus and exclusion of other hepatobiliary diseases) . 2.Traditional Chinese Medicine (TCM) syndrome differentiation classified as liver-gallbladder damp-heat syndrome or blood deficiency with internal heat syndrome . 3.Age between 18 and 40 years . 4.Voluntary participation in the study, with written informed consent and compliance with follow-up assessments .
Exclusion criteria
Exclusion criteria: 1.Age 40 years. 2.Presence of systemic diseases (e.g., severe primary cardiovascular, hepatic, renal, hematopoietic disorders) or psychiatric disorders. 3.Hypersensitivity to the study drug. 4.Non-compliance with inclusion criteria, failure to adhere to prescribed treatment protocols, or incomplete data that compromises efficacy/safety evaluation. 5.For ICP-diagnosed patients: exclusion of secondary causes of elevated bile acids or liver dysfunction, such as cholelithiasis, hepatic tumors, viral hepatitis, or other hepatobiliary pathologies .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of pruritus;Liver function and bile acids.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcome; | — |
Countries
China
Contacts
Public ContactChen Yan
Wansheng Economic and Technological Development Zone People's Hospital, Chongqing, China
Outcome results
None listed