| Objective:This research carried out methods in terms of randomness, blind control and parallel control based on real studies of clinical trail, which aims to test and verify the therapitic feasibility and efficacy of the Gui Zhi Fu Ling capsule (capsule of Cassia Twig and Tuckahoe) for treating primary dysmenorrhea, it also investigated the security of the medicine.Research Methods:1. Selection of samples:according to the baseline observation,59patients were diagnosed and chosen as the samples of the primary dysmenorrhea sufferers based on the western medical therapy whom also met the criteria of Chinese medical therapy for the syndrome of cold coagulation and blood stasis. They were randomly divided as the test group of39and the control group of20. Patients were required to take the medicine in the duration of the therapy of3menstrual cycles, decision on the relief of clinical symptoms andthe changes of Biochemical Markers of patients before and after drugs would help to evaluate the security and curative effectiveness of the medicine. There is no significant differences on age, height, weight and the general physical examination aspects (P>0.05) between the test group and the control group, nor the individual symptons and course of diseases (P>0.05)between them; therefore.it is worth comparison.2. Methods of drug distribution and medication:packages of drugs were blindly coded, and given each a ramdom serial number for each. Drugs were distributed to patients as the time they entered into the group by using the double dummy medicine. Medicament was taken begins at the end of menstruation lasting till the third day of next period. The test group: Gui Zhi Fu Ling capsule,3grains each time,3times daily; the control group:placebo capsule (starch),3grains each time,3times daily. 3. Effectiveness inspection:in the treatment duration of the3mentrual cycles, it was to observe and record the clinical symtons and grades, the lasting time of dysmenorrhea and the intensity of pain of patients before and after the treatment in each cycle. Follow-up suvery was taken place at the end of the treatment duration and would last for3month-mentrual cycles.4. Security inspection:Both the general physical examination and the biochemical markers inspection including temperature, heart rate, breath, blood pressure, the blood and urine routines, the liver and kidney functions and cardiogram were required to carry out before and after the therapy.5. Un--blinding and evaluation:the un-blinding took place as the follow-up surveys finished. The survey data were adopted into statistical analysis, with using t-test for measurement data,x2test for enumaration data and the Ridit analysis applied to ranked data. All them help in evaluating the effectiveness and security of medication.Results:1. Effectiveness on curing primary dysmenorrhea:39of the test group, recovered in17cases, having an effect in10cases, effective in7cases, invalid5cases, the total efficiency of87.18%;20of the control group, recovered1case, apparent effect1cases, effective0cases, invalid18cases, the total efficiency of10.00%. Effectiveness for the Chinese medical therapy:39of the test group, recovered26, apparent effect9, effective3, invalid1,97.44%for the total efficiency;20of the control group, recovered2, apparent effect1, effective1, invalid16, the total efficiency of20.00%.2. Side-effects:the two groups show little adverse reaction and drugs side-effect, and no anomalies saw in the general physical examination and the biochemical markers inspection. Conclusion:Gui Zhi Fu Ling capsule can cure the primarydysmenorrhea in the type of cold coagulation and blood stasis, it signicantly relieves the symptons ofdysmenorrhea, shortening the duration of pain, satisfied in treating the Chinese medical symptons related. There was no adverse side-effects occurred. |
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