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Kudo Capsule Clinical analysis of menorrhagia
PAGE \* MERGEFORMAT 7
Kudo Capsule Clinical analysis of menorrhagia
[Keywords:] Kudo capsule menorrhagia
Kudo capsule has hemostatic and analgesic effect. I expanded through a multi-center clinical trial to further observe the treatment of menorrhagia Duyiwei capsule effectiveness and safety of its making an objective evaluation.
1 Experimental Design
1.1 Test methods
A randomized, single blind, positive parallel controlled, multicenter clinical trial.
1.2 Drugs
Test drugs: Kudo capsules, pharmaceutical Co., Ltd. Gansu Kudo production, batch number size: 0.3 g / grain. Controlled drugs: Yunnanbaiyao capsules, Yunnan Baiyao Group Co., Ltd. production, batch number size: 0.25 g / grain.
1.3 treatment methods
Test group: single blind oral capsules, 3 times a day, 3 capsules each time. Control group: oral Yunnanbaiyao capsules, 4 times a day, each time 2. Treatment: 7 d to a course of treatment.
2 Case Selection
Inclusion criteria: ① Western diagnostic criteria consistent with menorrhagia [1], ② blood stasis Syndrome meet diagnostic criteria [1], ③ age from 14 to 50 year-old female, ④ informed consent, voluntary subjects. Comply with the above four standards can be incorporated into test cases.
Exclusion and exclusion criteria: ① The inspection confirmed the pregnancy, cancer, Sheung Wan, trauma or systemic disease caused by bleeding, ② the age of 14 years of age, 50 years of age, or breast-feeding women, ③ merger determination, brain, liver, kidney and hematopoietic system and other serious diseases, ④ the mentally ill, ⑤ of the drug allergy; ⑥ do not meet the inclusion criteria, according to the specified medication, can not determine the efficacy or impact of incomplete information such as efficacy and safety of judges.
3 Observation and Evaluation Indicators
3.1 Effectiveness Evaluation
Observation of menstrual flow, color, quality and duration, and associated symptoms and tongue, pulse changes.
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