Tuesday, 19 August 2003
This presentation is part of : Tuesday Poster Sessions

PB-099 A Double-Blind, Randomized Controlled Clinical Trial of TIANZHI Granule in Treatment of Mild-to-Moderate Vascular Dementia in China

Jinzhou Tian1, Aihua Zhu1, Jing Shi1, Jian Zhong1, Shulian Peng2, Xianfeng Liu3, and Yongyan Wang4. (1) Department of Care of the Elderly, Beijing University of Chinese Medicine Dongzhimen Hospital, Beijing, China, (2) Clinical Trials Office, Beijing University of Chinese Medicine Dongzhimen Hospital, Beijing, China, (3) Institute of Research and Development for Drugs, Wanxi Pharmaceutic Company LTD, Wanxi, China, (4) China Academy of Traditional Chinese Medicine, Beijing, China

Objective:TIANZHI granule includes gastrodine compound and other extracts from 7 herbs. This study aimed to evaluate the efficacy of the granule in patients with mild to moderate vascular dementia (VaD). Design: A randomized, double-blind controlled clinical trials. Materials and Methods:A 12 weeks of phase II clinical trial of randomized, double-blind, Duxil-control has been done in a Beijing hospital, one of the hospitals running this multi-centre clinical trials in 1999 to 2002. All patients after stroke were diagnosed with probable or possible VaD of >3 months'duration, according to NINDS-AIREN criteria. MMSE score =13-23. CDR=1.0 or 2.0 for mild to moderate dementia. 120 patients with VaD (M=75,F=45) were randomly divided into a treatment group (n=70) given 1 bag of TIANZHI granule (including 1.3mg Gastrodine compound) or a controlled group (n=50) given 1 granule of Duxil (40mg). 3 times a day for 12 weeks. All patients received assessments at baseline and endpoint using MMSE, and Blessed Behaviour Scale (BBS).

Results: In TIANZHI group, the mean MMSE score (20.83+/-5.63) increased significantly as compared with baseline score (18.96+/14.84) (P<0.05). Mean scores of memory, orientation, calculation, and language on MMSE also increased significantly than at baseline (P<0.05 to 0.01), but not significantly different from Duxil group. In TIANZHI group, the mean BBS score showed significantly difference between endpoint score (15.72+/-4.03) and baseline score (18.76+/-4.62) (p<0.01). There were more significantly improvement in mean BBS score (15.72+/-4.03), mean scores of activity of daily living (ADL)(7.30+/-2.04), habit (4.81+/-1.95), and personality (3.10+/-1.22) in TIANZHI group respectively than mean BBS score (17.08+/-4.31), mean scores of ADL (7.86+/-2.27), habit (5.32+/-2.16), and personality (3.86+/-1.28) in Duxil group (P<0.05).

Conclusion: TIANZHI granule is effective in the treatment for mild to moderate dementia of VaD, and is more evident of improvement of global functioning and ADL than Duxi. It may warrant further research into herbal therapeutics for VaD.

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