Tanshinone in Polycystic Ovary Syndrome
Palavras-chave
Resumo
datas
| Última verificação: | 08/31/2013 |
| Enviado pela primeira vez: | 10/05/2011 |
| Inscrição estimada enviada: | 10/11/2011 |
| Postado pela primeira vez: | 10/13/2011 |
| Última atualização enviada: | 09/02/2013 |
| Última atualização postada: | 09/03/2013 |
| Data real de início do estudo: | 09/30/2011 |
| Data Estimada de Conclusão Primária: | 11/30/2013 |
| Data Estimada de Conclusão do Estudo: | 06/30/2014 |
Condição ou doença
Intervenção / tratamento
Drug: tanshinone
Drug: tanshinone placebo
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Active Comparator: tanshinone tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. | Drug: tanshinone tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
| Placebo Comparator: tanshinone placebo placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. | Drug: tanshinone placebo placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Presence of PCOS diagnosed based on the Androgen Excess Society criteria. All subjects must have hyperandrogenism (hirsutism and/or hyperandrogenemia), ovarian dysfunction (oligoanovulation and/or polycystic ovaries), and exclusion of other androgen excess related disorders. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score ≥5 - Age of women from 18 to 35 years； - No desire of children within 6 month and use condoms for contraception. Exclusion Criteria: - Use of hormonal drugs or other medications, which can affect the results of the study especially Chinese herbal prescriptions in the past 12 weeks； - Patients with other androgen excess endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, severe insulin resistance, thyroid dysfunction； - Patients with history of sever cardiac , pulmonary, hepatic, renal, neurologic disease or mental illness； - Pregnancy or lactation. |
Resultado
Medidas de Resultado Primário
1. basal testosterone [3 months]
Medidas de Resultado Secundário
1. Ovarian androgen biosynthesis [3 months]
2. Whole body insulin action [3 months]
3. Oral glucose tolerance test (OGTT) [3 months]
4. Reproductive hormones [3 months]
5. Fasting gluco-lipid metabolic profiles [3 months]
6. quality of life [3 months]
7. Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment [3 months]
8. Adverse events [3 months]
