drugset / Trial / NCT01958866

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

NCT01958866

Phase 2/3 Completed 96 enrolled Chulalongkorn University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-10
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1000 mg
Subject Tinospora Crispa-extract Product Unknown 500 mg
Subject Tinospora Crispa-extract Product Unknown 2000 mg

Indications

No indication recorded.