[Translation] A randomized double-blind, placebo-controlled, parallel-controlled multicenter phase II clinical study to evaluate the efficacy and safety of Fuchun Granules in the treatment of kidney yin and yang deficiency syndrome in women with menopausal syndrome

初步评价妇春颗粒对更年期综合征症状群的治疗作用、对肾阴阳两虚证候及相关症状的改善作用，以及安全性观察。

[Translation]

To preliminarily evaluate the therapeutic effect of Fuchun Granule on the symptom cluster of menopausal syndrome, its improvement effect on the syndrome of kidney yin and yang deficiency and related symptoms, and its safety observation.

Start Date-

Sponsor / Collaborator

Jilin Province Beiyao Medicine and Medicinal Materials Station

100 Clinical Results associated with Fuchun Granules

100 Translational Medicine associated with Fuchun Granules

100 Patents (Medical) associated with Fuchun Granules

Literatures (Medical) associated with Fuchun Granules

01 Mar 2010·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Effect and safety evaluation of catgut implantation at acupoint for levels of bone metabolism and free radicals in postmenopausal women].

Article

Author: Xu, Yun-xiang ; Chen, Gui-zhen ; Zhang, Jia-wei ; Guo, Zhou-yi ; Liu, Song-hao

OBJECTIVETo compare the effect and safety evaluation of catgut implantation at acupoint and drugs for levels of bone metabolism and free radicals in postmenopausal women.METHODSSixty-five postmenopausal women were randomly divided into an acupoint catgut implantation group (33 cases) and a medication group (32 cases). Sanyinjiao (SP 6), Shenshu (BL 23) and Guanyuan (CV 4) were used as main points combined with adjunct points according to syndrome differentiation in the acupoint catgut implantation group, once two weeks. The medication group was treated with oral administration of 2 pills of Fu fuchun capsule, once a day. Three months constitute one course in the both groups. The scores of the symptoms and signs were evaluated, and elbow vein blood was drawn to detect the correlative index on the beginning and the ending day of the treatment respectively. The safety of catgut implantation at acupoint was evaluated after one course of treatment. Besides, the sex hormone test in ovulatory period was detected in twenty-eight normal women in reproductive age with regular menstrual cycle.RESULTS1) The total effective rate of the acupoint catgut implantation group was 93.9% (31/33), and that of the medication group was 96.9% (31/32), there was no significant difference between the two groups (P>0.05). The contents of bone gla protein (BGP), calcitonin (CT), parathyroid hormone (PTH) and alkaline phosphatase (AKP) in the both groups had significant differences after treatment (P<0.05, P<0.01); 2) The content of estradiol (E2) in serum in the both groups was decreased more obviously than those of normal women in reproductive age (both P<0.001). The content of E2 in the both groups was obviously increased after treatment (P<0.05, P<0.01), this function in the acupoint catgut implantation group was weaker than that of the medication group (P<0.05), while the incidence rate of adverse effect in the acupoint catgut implantation group was lower than that of the medication group (P<0.05); 3) There were significant differences of the level of superoxide dismutase (SOD) and malondialdehyde (MDA) before and after treatment in the acupoint catgut implantation group, the level of SOD was obviously increased after treatment (P<0.01), while the level of MDA decreased obviously (P<0.001).CONCLUSIONCatgut implantation at acupoint can improve the low level of estrogen of postmenopausal women, with good safety. It can regulate the levels of bone metabolism and free radicals of postmenopausal women, so it is very meaningful to prevent and treat postmenopausal degenerative diseases including the osteoporosis and to delay the process of apolexis.

100 Deals associated with Fuchun Granules

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Indication	Highest Phase	Country/Location	Organization	Date
Menopausal syndrome	Phase 2	CN	Jilin Province Beiyao Medicine and Medicinal Materials Station	14 Mar 2014

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