Ratree Maenthaisong1, Nathorn Chaiyakunapruk2, Waree Tiyaboonchai3, Apiwat Tawatsin4, Archawin Rojanawiwat5, Usavadee Thavara4. 1. Clinical Pharmacy Research Unit, Department of Clinical Pharmacy, Faculty of Pharmacy, Mahasarakham University, Mahasarakham, Thailand. 2. Discipline of Pharmacy, Monash University Sunway Campus, Jalan Lagoon Selatan, Bandar Sunway 46150, Selangor, Malaysia; Center of Pharmaceutical Outcomes Research, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; School of Pharmacy, University of Wisconsin, Madison, WI, USA; School of Population Health, University of Queensland, Brisbane, QLD, Australia. Electronic address: nathorn.chaiyakunapruk@monash.edu. 3. Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. 4. The National Institute of Health, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand. 5. Clinical Research Center, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.
Abstract
INTRODUCTION: Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl, and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis, pain, and inflammation for a long time, there is no clinical evidence to confirm its efficacy and safety. Therefore, we performed a double-blind, within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions. METHODS:All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule. The main outcome was the difference of papule size reduction at 30 min, measured by a caliper, between the Trikatu and reference arms. Pruritis, redness, pain, and patient satisfaction were assessed at 15, 30, 60, 180, and 360 min as secondary outcomes. RESULTS: There were no significant differences between treatment and reference arms on any outcome at any time of measurement. CONCLUSION: Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor, menthol, and eucalyptus. For further study, it is very important to consider a proper selection of subjects, comparator product, and concentration of extract when Trikatu preparation is investigated.
RCT Entities:
INTRODUCTION: Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl, and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis, pain, and inflammation for a long time, there is no clinical evidence to confirm its efficacy and safety. Therefore, we performed a double-blind, within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions. METHODS: All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule. The main outcome was the difference of papule size reduction at 30 min, measured by a caliper, between the Trikatu and reference arms. Pruritis, redness, pain, and patient satisfaction were assessed at 15, 30, 60, 180, and 360 min as secondary outcomes. RESULTS: There were no significant differences between treatment and reference arms on any outcome at any time of measurement. CONCLUSION: Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor, menthol, and eucalyptus. For further study, it is very important to consider a proper selection of subjects, comparator product, and concentration of extract when Trikatu preparation is investigated.
Authors: Muhammad Shahid Nisar; Muhammad Awais Ismail; Hassan Ramzan; Muhammad Mudassar Maqbool; Tasneem Ahmed; Hamed A Ghramh; Ahlam Khalofah; Jaroslav Kmet; Marek Horvát; Shahid Farooq Journal: Saudi J Biol Sci Date: 2021-04-02 Impact factor: 4.219