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The Mechanism of Yangyin Shugan Capsule in Treating Premature Ovarian Insufficiency Based on Multi-Omics Analysis

The Mechanism of Yangyin Shugan Capsule in Treating Premature Ovarian Insufficiency Based on Multi-Omics Analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000820
Enrollment
Unknown
Registered
2024-12-13
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Premature ovarian insufficiency

Interventions

Control group (placebo) :Placebo capsules, 4 capsules, tid, with warm water for 12 weeks.
Treatment group (Yangyin Shugan capsule) :Yangyin Shugan capsules, 4 capsules, tid, taken with warm water for 12 weeks.

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of traditional Chinese and western medicine; 2. Age: 18-40 years old female (excluding 40 years old); 3. Menstrual cessation time < 6 months; 4. Those who can sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Chromosomal abnormalities; 2. Patients with the following gynecological pelvic surgery history: ovarian cyst removal oophorectomy ovarian wedge resection salpingectomy tubal ligation etc. 3. The use of reproductive toxic drugs such as tripterygium wilfordii chemotherapy drugs or radiotherapy and other iatrogenic factors; (4) severe autoimmune and metabolic diseases; 5. Pregnancy and childbearing within the past six months. 6. Treatment with hormones selective estrogen receptor modulators aromatase inhibitors soy extracts etc. in the past 3 months; 7. Patients with a history of habitual use of antibiotics or use of antibiotics probiotics prebiotics or live micro-ecological bacteria preparations in the past 1 month; Laxatives or other drugs affecting gastrointestinal function; 8. Severe liver kidney heart and brain diseases; Patients with malignant tumors; People with severe mental disorders.

Design outcomes

Primary

MeasureTime frame
bFSH;Menstrual score sheet;

Secondary

MeasureTime frame
bE2;Gut microbiota 16S-rDNA sequencing Gut microbiota 16S-rDNA sequencing;Metabolomics analysis of stool and blood;SAS;Blood immune cytokines;AMH;SDS;Modification of the KI scale;TCM syndrome scale;Transvaginal Ultrasound;

Countries

China

Contacts

Public ContactHuang Xuchun

Guangdong Provincial Hospital of Traditional Chinese Medicine

15013138001@163.com15013138001

Outcome results

None listed

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