Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

Last updated: September 6, 2023
Sponsor: Jiangxi University of Traditional Chinese Medicine
Overall Status: Active - Recruiting

Phase

1/2

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Jianpi Qushi Huatan Decoction

Placebo

Clinical Study ID

NCT05976295
20223BBG71012-2
  • Ages 18-40
  • Female

Study Summary

Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Jianpi Qushi Huatan Decoction) in women with PCOS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The diagnosis of PCOS is based on the Rotterdam criteria.
  2. Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness inTCM theory.
  3. women aged 18-40 years without fertility requirements.
  4. A willingness to undergo this treatment plan.

Exclusion

Exclusion Criteria:

  1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least oneweek apart).
  2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10IU/L.
  3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2mIU/mL or more than 5.5 mIU/mL.
  4. Suspected Cushing's syndrome.
  5. Adrenal or ovarian tumors secreting androgen.
  6. Poorly controlled type II diabetes.
  7. Pregnancy or lactation.
  8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressuremore than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
  9. Those who had taken hormones or other drugs during the previous 3 months.
  10. Acute heart, liver, kidney or blood diseases.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Jianpi Qushi Huatan Decoction
Phase: 1/2
Study Start date:
August 31, 2023
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    Nancang, Jiangxi
    China

    Active - Recruiting

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