ITMCTR2100004448招募中4 期
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
Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- Female
入选标准
- •(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.
排除标准
- •(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.
研究者
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