Objective: To observe the change of syndrome factors and mechanism of Zhen Zao Capsule in the treatment of senile patients with yin-deficiency and fire-excess insomnia. Methods: 120 cases were randomly divided into treatment group A and treatment group B, 60 cases in each group. The treatment group A patients were given Zhen Zao Capsule half an hour before sleep, and the treatment group B patients were treated with Bailemian Capsule at the same time. After the treatment of 4 weeks, the relevance between insomnia's factor in TCM and the relevant neurotransmitters such as 5-hydroxytryptamine(5-HT) and dopamine(DA)was explored, as well as the clinical effects and the law of evolution about syndrome factor of two groups were evaluated. Results: The clinical effects of both groups were equal. However, in terms of improving the TCM syndromes and effects, the treatment group A was superior to the treatment group B(P<0.05). Before and after treatment, 5-HT increased while DA decreased. Amplitude of accommodation in the treatment group A was significant better than that of the treatment group B(P<0.05), especially in the symptom factor of liver and heart. Both groups had no significant difference on the effect of the symptom factor of kidney(P>0.05). Conclusion: With significant clinical effects, Zhen Zao Capsule can improve insomnia in senile patients; it has a remarkable curative effect on syndrome factor. It has achieved a good clinical effect.
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