Clinical Trial Phase I of Prasaprohyai Extract Capsules
Mukkasombut N, MSc1, Chanvimalueng W, MD2, Itharat A, PhD1,3, Budsaba K, PhD4, Ooraikul B, PhD5
Affiliation : 1 Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand 2 Department of Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand 3 Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathumthani, Thailand 4 Department of Mathematics and Statistics, Faculty of Science and Technology, Thammasat University, Pathumthani, Thailand 5 Department of Agricultural Food and Nutritional Science, Faculty of Agricultural Life and Environmental Sciences, University of Alberta, Edmonton, Alberta T6G 2P5, Canada
Background : Prasaprohyai remedy (PSPR) is a Thai traditional medicine that has long been used to treat the common cold and fever. Previous
studies revealed that PSPR powder can relieve allergic rhinitis symptoms as effectively as Loratadine. The usual dose was 3,000 mg/day;
however, if the extract could be used it may be possible to reduce the dosage. Therefore, it is necessary to find out if the administration of PSPR
ethanolic extract to healthy volunteers is safe.
Objective : To study the safety of PSPR ethanolic extract in healthy volunteers.
Materials and Methods : The present study was a randomized, open-labelled, trial for safety assessments in 24 healthy volunteers. The volun-
teers were divided into two groups, one group receiving 3x100 mg/day and the other group receiving 3x200 mg/day before meal for 6
weeks. The blocked randomization was done by a computer program with equal distribution of genders. The experiment with group 2 started
after finishing with group 1. There was a wash-out period after week 6th. All volunteers were followed-up in the 3rd week, 6th week and 8th
week to evaluate the safety of the medicine.
Results : There was no toxicity of PSPR to the liver and kidney. The results on blood glucose, lipid profile and complete blood count were normal.
Conclusion : The PSPR remedy ethanolic extract capsules at 300 and 600 mg/day were safe to use in healthy volunteers for 6 weeks, with mild
side effects. Oral administration was recommended after meals.
Keywords : Prasaprohyai remedy, Safety, Complementary medicine, Herbal extract
