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

NCT05976295 | Unknown Phase 1

• 1 other identifier: 20223BBG71012-2
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Ovulation rate

  Ovulation rate in each group during the study period.

  3 months

Study Arms (2)

Therapy group

EXPERIMENTAL

Drug: Jianpi Qushi Huatan Decoction

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Jianpi Qushi Huatan Decoction DRUG

The treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will take the medication from the first day of inclusion, dissolving and consuming one packet twice a day (morning and evening) for a total of three months.

Therapy group

Placebo DRUG

The control group will receive a placebo treatment.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Liang Ruining

CONTACT

0086-0791-88385243; jack169@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 31, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

CN (1)