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The Qilingwenshenxiaonang recipe in the treatment of patients with Polycystic ovary syndrome(PCOS): a multicenter, randomised, double-blind, placebo controlled trial

The Qilingwenshenxiaonang recipe in the treatment of patients with Polycystic ovary syndrome(PCOS): a multicenter, randomised, double-blind, placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008557
Enrollment
Unknown
Registered
2016-05-29
Start date
2016-06-10
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Polycystic Ovary Syndrome

Interventions

Experimental group:Qilingwenshenxiaonang recipe
The control group:Placebo of Qilingwenshenxiaonang recipe

Sponsors

First Affiliated Hospital Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged 20-40 years; 2. According to PCOS criteria defined by Endocrinology Group, Association of gynecology&obstetrics, Chinese Society of Medicine; 3. TCM syndrome differentiation with phlegm-damp type; 4. Body mass index in 24 kg/m2 to 30 kg/m2; 5. Insulin resistance index>=2.69; 6. No fertility requirements in the process of taking medicine; 7. the patient who is Voluntary to participate in this study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other causes of disease similar to PCOS such as Ovarian or adrenal gland tumor, adrenal cortical hyperplasia, Cushing syndrome, high prolactin, and thyroid disease; 2. Diagnosed with diabetes; 3. Suffering from serious diseases such as digestive tract diseases, respiratory diseases, blood system diseases, urinary system diseases, nervous system diseases, mental illness and other serious diseases; 4. Uncontrolled hypertension(DBP=160/100mmHg)or hypotension(SBP<95 mmHg); 5. hepatic and renal function abnormity(ALT,AST were 2 times higher than normal level; serum creatinine dyslipidemia); 6. Use of hormonal drugs in the past 3 months; 7. Participants in other drug trials in the past 1 months.

Design outcomes

Primary

MeasureTime frame
ovulation rate;menstruation changes;Sex hormone index;glucose and lipid metabolism index;anthropometric parameters;Ultrasound showed polycystic ovary status;

Countries

China

Contacts

Public ContactLihui Hou

Heilongjiang University of Chinese Medicine

houlihui2007@sina.com+86 13796088738

Outcome results

None listed

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