A Preliminary Standardisation and a Phase 2 Efficacy Trial on Healthy Volunteers of a Polyherbal Formulation Against Hiora-K Herbal Mouthwash

Abstract

Oral hygiene plays an important role in a man's health. Many bacteria are residing in the oral cavity. When the healthy favourable condition of the oral cavity changes, these are producing diseases. Many types of oral toiletries are available in the market for maintaining the oral health. But the increasing prevalence of the oral diseases indicates its insufficiency. And this chemical compounds also poses threat to the human health. Hence, a cost effective simple palatable fast acting herbal substitute having antimicrobial activity is needed. Susrutācārya mentioned a pratisārana yoga containing Dhātaki, Pathya, Jambu along with honey in the context of "Dantakāṣthagata viṣa.", here it was used as kabala. Methods: Preliminary standardization of the drug by determination of physiochemical parameters,phytochemical screening and HPTLC Profiling were done. An RCT to assess the antimicrobial activity clinically in 50 healthy volunteers by counting the number of colonies before and after in comparison with Hiora-K Herbal mouthwash with OHAT score one and above 1.The observations are statistically analysed using dependent sample 't' test. Result: Clinically this formulation showed highly significant antimicrobial activity against Hiora-K herbal mouthwash. Conclusion: Dhātakyādi agada is a safe and cost effective antimicrobial drug. The presence of tannins, alkaloids, flavonoids, alkaloids, glycosides, steroids, phenols, saponins etc may contribute to this action. It process molecular, cellular and even DNA level action. It is evident that this agada is bacteriostatic and bactericidal in properties It also has kṛimihara, vṛanahara and vișaharafproperty.