Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen

No Liver and Kidney Problem Clinical Trial

Status Completed

Clinical Trial Summary

Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.

This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5 without any signs of infections will be enrolled in this study. Patients will be randomly divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group will receive placebo twice daily.

Clinical Trial Description

Patients in each group will be monitored for body temperature at baseline (at the time of enrollment) and at 1, 2, 4, 6, 8, 24 h after receiving the tested material. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• No Liver and Kidney Problem
• No Sign of Infection
• Patients With Body Temperature Between 37.8-38.5

• NCT number: NCT01958866
• Study type: Interventional
• Source: Chulalongkorn University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2013
• Completion date: December 2014