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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Age over 18 years old

• Body temperature between 37.8-38.5

• Body weight not less than 40 kg but not over 100 kg

• Liver enzymes do not exceed 2 times of normal value

• Can comply with study protocol

Exclusion Criteria:

• Have allergic history of any tested compounds

• Fever from other causes, not by URI

• Take any herbal medicines during 2 weeks before enrollment

• Physicians decide to withdraw the subjects with any reasons