| Objective: The paper aims to observe the effect of Ophiopogon japonicus and Hemp seed Decoction on treatment of senile functional constipation and deficiency of intestinal dryness and body fluid deficiency through randomized clinical trial(RCT) to further understand the compatibility law of prescription, thereby develop better prevention and treatment of senile functional constipation.Methods: 60 patients with senile functional constipation and deficiency of intestinal dryness and body fluid deficiency are divided into treatment group and control group at random, 30 patients for each group. Patients in treatment group take Ophiopogon japonicus and Hemp seed Decoction while those in control group take Hemp seed capsule for equal 15 days. The total curative effect and effect on TCM syndrome will be observed after treatment. Meanwhile, adverse reaction and drug safety are continuously concerned during the treatment process and follow-up phase.Results: In terms of the total curative effect of two drugs for senile functional constipation, the research shows the rate of treatment group stands at 93.3% while that of control group is 83.3%. The difference between the two groups is statistically significant(P < 0.05) and it shows that Ophiopogon japonicus and Hemp seed Decoction is more effective than Hemp seed pill. In the matter of treatment of TCM syndrome, both Ophiopogon japonicus and Hemp seed Decoction and Hemp seed pill are both remarkably effective(P<0.01), the rate of treatment group stands at 96.7% while that of control group is73.3%. The difference between the two groups is statistically significant(P<0.01) and it shows that Ophiopogon japonicus and Hemp seed Decoction is also more effective than Hemp seed pill. As regard to the enhancement of TCM syndrome integral, Ophiopogon japonicus and Hemp seed Decoction is superior to Hemp seed pill in improving dry stool and body fluid deficiency for patients(P<0.01). When it comes to treating long defecation interval, fatigue, and Abdominal distension and abdominal pain, the two groups differs little. After a one-month follow-up to the patients that have been effectively treated(including the completely effective, remarkably effective and effective), the results shows that Ophiopogon japonicus and Hemp seed Decoction is more effective than Hemp seed capsule in long-term treatment. In the matter of drug safety, patients of neither group are reported having adverse reactions.Conclusion: Ophiopogon japonicus and Hemp seed Decoction is clinically effective in treating senile functional constipation and deficiency of intestinal dryness and body fluid deficiency. Moreover, no adverse reactions are reported in the process of neither treatment nor follow-up. |