Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: protocol for a randomized controlled pilot trial
- Conditions
- Polycystic ovarian syndrome
- Registration Number
- ITMCTR2100004448
- Lead Sponsor
- Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
(1) Chinese women aged from 18 to 35 years old.
(2) BMI over 25.0 kg/m2.
(3) Confirmed diagnosis of PCOS according to the 2003 Rotterdam criteria:
(a) irregular menstruation cycles (a periodic interval > 35 days or < 8 cycles in a year) or amenorrhea (a periodic interval > 90 days) or abnormal uterine bleeding;
(b) clinical manifestations of hyperandrogenism (hirsutism in mainland China is taken as Ferriman-Gallwey score >= 5) and/or hyperandrogenemia [free androgen index (FAI)=total testosterone (nmol/L)/SHBG (nmol/L) x 100 >4.5]; and
(c) transvaginal ultrasonography showing PCOM: the number of follicles with a diameter of 2-9 mm in one or both ovaries >= 12, and/or ovarian volume >= 10 ml [ovarian volume calculation: 0.5* long diameter (cm) * diameter (cm) * anteroposterior diameter (cm)]. Among all the above, (a) is a necessary condition, and matching one of (b) or (c) represents suspected PCOS, which then requires ruling out other factors and diseases that may cause hyperandrogenism and ovulation dysfunction.
(4) In line with the diagnosis criteria of TCM syndrome differentiation: kidney deficiency and phlegm dampness.
(5) Confirming the diagnosis of insulin resistance: the criteria of IR are defined according to the homeostatic model assessment of insulin resistance (HOMA-IR) [fasting plasma glucose (mmol/l) * fasting serum insulin (uIU/ml)/22.5]. A value >= 2.29 is considered to be indicative of IR.
(6) No history of using hormone drugs or drugs that affect glucose metabolism within the 3 months prior to treatment.
(7) Volunteer to participate in this trial and give informed consent.
(1) Patients with any other endocrine diseases related to this disease (such as Cushing's syndrome, congenital adrenal hyperplasia, 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, type 1 or type 2 diabetes mellitus, etc. ).
(2) Patients with congenital malformations or defects of the reproductive system, organic lesions of the reproductive system (such as uterine fibroids, ovarian cysts, etc. ).
(3) Patients with reproductive malignancies (such as endometrial cancer, cervical cancer, etc. ).
(4) Patients with genital inflammation, genital tuberculosis, and pelvic inflammatory disease.
(5) One of the spouses has a sexually transmitted disease such as syphilis and AIDS.
(6) Patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems or psychoses.
(7) Patients with chromosomal abnormalities, pregnancy or lactation.
(8) Interventions of any other medication treatments, including hormone drugs, drugs that will affect glucose metabolism, Chinese herbal prescriptions or acupuncture in the previous 3 months.
(9) Patients allergic to the drugs used in this study.
(10) Patients in other clinical trials at the same time.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OGTT;HOMA-IR;INS;
- Secondary Outcome Measures
Name Time Method the clinical pregnancy rate;Ferriman-Gallwey scores;FAI;the levels of basic serum sex hormones;BMI;TCM syndrome scores;the ovulation rate in each menstrual cycle;