Other Clinical Research
In 2005-06, three additional safety trials were implemented on NeuroAiD™. The conclusion of these studies is that NeuroAiD™ can safely be administered without modification of hematological and bio-chemical parameters.
Below is an abstract of the scientific paper written after completion of studies, this paper has undergone peer-review process and will be published in the Cerebrovascular Disease Journal.
Danqi Piantan Jiaonang does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients, – Robert Gan; Caroline Lambert; Jiao Lianting; Edwin SY Chan; N Venketasubramanian, Christopher Chen; Bernard PL Chan; Michel Meyer Samama; Marie Germaine Bousser.
Abstract:
Background and Objective: Previous studies on Danqi Piantan Jiaonang (DPJ), a traditional Chinese medicine, in stroke patients showed promising results. Our aim was to determine the safety of DPJ in normal subjects and stroke patients through a series of studies assessing its immediate and long-term effects, alone and in combination with aspirin, on hematological, hemostatic, and biochemical parameters.
Methods: We conducted three studies from December 2004 to May 2006. Study I was a case series which recruited 32 healthy volunteers who were given two oral doses of four DPJ capsules (0.4g/ capsule) six hours apart. Study II was a randomized controlled trial of 22 healthy volunteers to receive either one oral dose of aspirin 300 mg alone or a combination of one dose of aspirin 300 mg and two doses of four DPJ capsules taken six hours apart. For both studies I and II, hemostatic parameters (PT, aPTT, Fibrinogen, platelet aggregation, D-Dimer) were tested at baseline, 2 hours, and 8 hours. Study III was a case series which recruited 10 patients with recent ischemic stroke (within 7 days) who were given four DPJ capsules taken orally three times a day for one month. Blood tests for hemostatic, hematological (complete blood count), and biochemical parameters (glucose, creatinine, ALT, AST, C-reative protein) were performed at baseline, 1 week, and 4 weeks.
Results: Apart from the expected changes in platelet aggregation in subjects taking aspirin, no significant differences were detected in hemostatic parameters at baseline, 2 hours, and 8 hours after oral intake of DPJ alone or in combination with aspirin. Likewise, no significant differences were observed in hematological, hemostatic, and biochemical parameters at baseline, 1 week, and 4 weeks of oral intake of DPJ.
Conclusion: Danqi Piantan Jiaonang (NeuroAiD®) does not significantly modify hematological, hemostatic, and biochemical parameters in normal subjects and stroke patients.
A number of other reports have been published in medical peer review journal independently of the CHIMES society, including:
