A scientific approach to evaluate Siddha polyherbal formulation Thontha sura Kiyaazham (TSK) for its Safety and Therapeutic efficacy in experimental animal models and children for the management of clinically diagnosed Suram (Viral Fever)with reference to upper respiratory tract infection

INTRODUCTION

Siddha Medicine is  an ancient medical system in the world which is believed to be originated more than many thousands years ago. Siddha medicine classifies disease and disorders into 4448 types and has remedy for more than 64 types of fever. Siddha literature says that fever is the main symptoms for many diseases. The trial drug Thontha Sura Kiyaazham is mentioned in Siddha literature and indicated to treat all types of fever.

MATERIALS AND METHODS

Children aged between 6 to 12 years of all genders will be included in the trial after signing consent form. Participants reporting at the Kuzhanthai maruthuvam OPD at NIS associated with clinical features of fever, Pharyngitis, Dry Cough, coryza, Headache, Myalgias. Chills, Malaise and anorexia will be chosen for enrolment, based on the inclusion criteria.

EXPECTED OUTCOME

This study will explore the reduction of the oral temperature from baseline reading with monitoring time duration for fall in temperature and clinical improvement in associated symptoms. The outcome of the treatment should be measured statistically by using appropriate analysis of variance test.

ETHICAL ISSUES

The data collected from the Participants informant will be recorded. The Participants informant will be informed about the diagnosis, treatment and follow- up.

After the consent of the Participants informant (through consent form), Participants will be enrolled in the study.Informed consent will be obtained from the Participants informant explaining in the understandable language to the Participants informant.

Treatment would be provided free of cost. In conditions of treatment failure, adverse reactions, Participants will be given alternative treatment at the National Institute of Siddha with full care. In case of severity condition Participants will be referred to nearby Government Hospital.