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RecruitingNCT05976308Updated Sep 8, 2023

Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

A Phase 1/2 interventional study of Bushen Huatan Decoction and Placebo in Polycystic Ovary Syndrome, sponsored by Jiangxi University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Jiangxi University of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

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 (Bushen Huatan Decoction) in women with PCOS.

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 68 is close to the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Jiangxi University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
  2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
  3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/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 pressure more 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Therapy group

    Drug: Bushen Huatan Decoction

  • Placebo comparator
    Control group

    Drug: Placebo

Interventions

  • DrugBushen Huatan Decoction

    The treatment group used Bushen Huatan Decoction, including Tusizi (the seed of Chinese dodder), Fupenzi (Raspberry), Bajitian (Morinda officinalis), Duzhong (Eucommia ulmoides), Shudi (prepared Rehmanniaroot), Fuling (Tuckahoe), Zelan (Aconitum gymnandrum), Zexie (Rhizoma alismatis), Guizhi (Cassia twig), Zhebeimu (Thunberg Fritillary Bulb), Taoren (Peach kernel) and Chuanxiong (Ligusticum wallichii). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

  • DrugPlacebo

    The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.

06

What researchers measure

Primary outcomes

  1. Ovulation rate

    Ovulation rate in each group during the study period

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2023
First posted
Aug 4, 2023
StartActual
Sep 1, 2023
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 1, 2025
Last update
Sep 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05976308
Lead sponsor
Jiangxi University of Traditional Chinese Medicine
Responsible party
Ruining Liang (chief physician, Jiangxi University of Traditional Chinese Medicine) — Principal investigator
First posted
Aug 4, 2023
Start date
Sep 1, 2023
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Sep 8, 2023

Study contacts

Ruining Liang
Contact
jack169@sina.com
0086-0791-88385243

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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