This article was inspired by the paper that Clinical Research of Traditional Chinese Medicine NeedsA Breakthrough, which was written by Shang Hongcai. This article took the 11th Five-year Plan of the National Science and Technology Support Project and the National Public Welfare Projects of Chinese Medicine, which were undertaken by the Heilongjiang Gynecology , which is one of the National Trial Bases of Chinese Medicine as an example to illustrate the Chinese medicine clinical trial management , achievement producing , and realization of achievement transformation . The emphasis should be made on the optimization of Chinese medicine clinical trial from the topic selection , operation mode and quality control . A comprehensive and detailed management system should be worked out to ensure the smooth conduction of clinical trials. The clinical research results should be clarified to achieve high quantity and quality outputs . The article was aimed to provide references for the development and breakthrough of Chinese medicine clinical trials .

Objective The insulin pathways within ovary are in close relationship with female reproductive ability .The arti-cle was to observe the effects of ovarian insulin resistance on ovarian function and the effects of cryptotanshinone (CRY) on ovarian in-sulin resistance. Methods All mice were randomly divided into saline group (isotonic saline), DEX a group (isotonic saline plus DEX), CRY a group(isotonic saline plus DEX plus cryptotanshinone ), 10 in each group.The degree of insulin resistance was tested on each rat, along with the measurement of disintergrations per minute (DPM), ovulation rate and serum hormone level .After 20 fe-male mice were put to death , their ovaries were randomly divided into 4 groups:blank control group ( blank culture solution ) , DEX b group (DEX), CRY b group(DEX plus cryptotanshinone ), and WT group (DEX plus cryptotanshinone plus wortmannin ), 8 in each group. Murine ovaries in each group were cultured in vitro to test the number of ovarian glucose and the serum hormone level . Results After in-
sulin resistance took place in murine ovaries , significant statistical difference was found between DEX a group and saline group as to 2-deoxy-D-[1,2-3H]-glucose, liver, adipose and ovarian tissues (P<0.05).Ovaries in CRY a group increased significantly compared with DEX a group([2805.2 ±921.5]DMP/mg vs [1183.2 ±382.2]DMP/mg, P<0.01 ).Compared with DEX a group(37.5 ± 7.0, 5.0 ±1.8), the ovulation rate and the average corpus luteum in saline group (26.3 ±5.9, 3.5 ±1.6) and CRY group (27.2 ± 6.3,3.8 ±0.9) decreased (P<0.05).In comparison to DEX a group, the estrogen and progestogen levels in saline group and CRY a group decreased significantly(P<0.05).The expression level of AKT2 protein in DEX a group was much lower than that in saline group([0.39 ±0.01] vs [0.77 ±0.03], P<0.05).The glucose uptake in ovarian tissues cultured in vitro in blank control group , DEX b group, CRY b group and WT group was respectively (3447.2 ±1245.2)DMP/mg, (1183.2 ±382.2) DMP/mg, (2805.2 ± 921.5) DMP/mg, and (1364.2 ±292.3) DMP/mg.DEX b group decreased significantly compared with blank control group , DEX b group and WT group decreased significantly in comparison to CRY b group (P<0.05).In comparison to blank control group, the me-dium testosterone level increased and the protesteron level decreased significantly in DEX b group (P<0.05). Conclusion Tradi-tional Chinese medicine cryptotanshinone can relieve ovarian insulin resistance in vitro and in vivo , and it may exert insulin sensitivza-tion through PI3K pathway.

OBJECTIVE: To investigate the effect of ginseng total saponins (GTS) on expression of nerve growth factor in rat with polycystic ovaries. METHODS: A total of thirty rats were randomly divided into normal control group, untreated group and GTS group. Polycystic ovaries were induced by a single intramuscular injection of 4 mg estradiol valerate (EV) in rats of the untreated group and GTS group. The rats in the GTS group were administered 50 mg/kg GTS every other day by intraperitoneal injection for 30 days after the EV injection. The expressions of NGF in the ovaries, pituitary and hippocampus were observed by method of immunohistochemistry. RESULTS: Comparison with the normal control group revealed that the expressions of NGF in ovaries, pituitary and hippocampus of rats in the untreated group were increased (P<0.05). The ovarian morphology of the GTS group was almost as normal as that of the normal control group. As compared with the untreated group, the expression of NGF in ovaries of the rats in GTS group was obviously decreased (P<0.05), while the expression of NGF in pituitary and hippocampus showed on difference. CONCLUSION: GTS can decrease the expression of NGF in ovary tissue in rats with polycystic ovaries induced by EV, which may be its mechanism in lessening the polycystic ovary.

Protocol design and implementation are important steps for clinical trial . This article discussed key issues on effect of live birth rate by polycystic ovary syndrome ( PCOS ) treatment with acupuncture combined with clomiphene citrate in the randomized controlled trial ( RCT ) process . For example , the trial designs ( i . e . , trial design characteristics , selection of featured therapeutic effect index ) , clinical trial implementation ( i . e . , or-ganization construction , quality control , and etc . ) . This summarization provided references for the design and implementation of clinical trial plan .