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Observations on the ovulation-promoting efficacy of Zishen Yutai Pill in the treatment of polycystic ovary syndrome (spleen-kidney deficiency and phlegm-dampness obstruction syndrome) and its effects on tongue-intestinal flora

Observations on the ovulation-promoting efficacy of Zishen Yutai Pill in the treatment of polycystic ovary syndrome (spleen-kidney deficiency and phlegm-dampness obstruction syndrome) and its effects on tongue-intestinal flora

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081821
Enrollment
Unknown
Registered
2024-03-13
Start date
2023-06-20
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

polycystic ovary syndrome (PCOS)

Interventions

ZSY group:Start taking Letrozole on the 5th day of each menstrual cycle, 2 tablets of 5mg once daily after meal for 5 days. On top of this, Zishen Yutai Pills should be added, starting from the 5th da
control group:Start Letrozole on day 5 of each menstrual cycle, take 2 tablets of 5mg once daily with meals for 5 days. On top of this, Zishen Yutai Pills placebo was added, starting from the 5th day

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria of polycystic ovary syndrome in Western medicine; ? Meet the TCM diagnostic criteria of spleen and kidney deficiency and phlegm-dampness obstruction syndrome; ? Women aged 20-40 years old with reproductive needs; ? Good mental condition, able to complete the questionnaire independently; ? Subjects and their families give informed consent, voluntarily sign the informed consent form, and voluntarily accept the treatment according to the requirements and cooperate with this study. ? The subjects and their families gave informed consent, voluntarily signed the informed consent form, and voluntarily accepted the treatment according to the requirements and cooperated with this study; (vi) No hormonal drugs or Chinese herbal medicines or proprietary Chinese medicines that tonify the kidney and spleen, resolve phlegm and dispel dampness have been used in the last 3 menstrual cycles.

Exclusion criteria

Exclusion criteria: ?Taking Chinese herbal medicines and proprietary Chinese medicines related to the treatment of polycystic ovary syndrome within 3 months prior to the trial, and those who have been treated with sex hormone drugs or contraceptive pills within 3 months; ? Combined gonadal hypoplasia, organic lesions of reproductive organs, thyroid disease, poorly controlled diabetes mellitus, hyperprolactinaemia, suspected Cushing's syndrome, congenital adrenal hyperplasia, gastrointestinal and digestive system diseases; ?Patients with combined heart, liver, kidney, gastrointestinal tract and other serious organic diseases; ?Patients with abnormal liver function (ALT, AST, ALP, GGT>2 times the upper limit of normal value), abnormal renal function (BUN>30mg/dl or serum creatinine>1.4mg/dl); ? Those who are allergic or hypersensitive to the drugs or food ingredients involved in this study; ? Those who have taken any antibiotics, probiotics, prebiotics, proton pump inhibitors within 30 days; (vii) Poor compliance, inability to return to the hospital in time to complete the visit, and difficulty in adhering to the completion of the entire clinical trial.

Design outcomes

Primary

MeasureTime frame
Volume of follicles;Number of follicles;Thickness of the endometrium;ovulation rate;

Secondary

MeasureTime frame
TCM syndrome efficacy quantitative evaluation score;diversity, abundance of lingual flora;diversity, abundance of intestinal flora;

Countries

China

Contacts

Public ContactLei Zeng

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

407687448@qq.com+86 153 3808 0531

Outcome results

None listed

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