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

Phase 2

Completed

• Conditions: Patients With Body Temperature Between 37.8-38.5; No Liver and Kidney Problem; No Sign of Infection
• Interventions: Drug: Tinospora Crispa-extract Product; Other: Placebo; Drug: Acetaminophen

• Registration Number: NCT01958866
• Lead Sponsor: Chulalongkorn University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2013-09-11
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tinospora Crispa-extract Product	Tinospora Crispa-extract Product	Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented
Placebo	Placebo	Placebo 2 tablets will be administered every 4 hours when fever is presented
Acetaminophen	Acetaminophen	Acetaminophen administer 1000 mg every 4-6 hours when fever is presented

Primary Outcome Measures

Name	Time	Method
Body Temperature	Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours

Secondary Outcome Measures

Name	Time	Method
Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine	Participants will be followed for the duration of hospital stay (24 hours)	Liver and kidney function will be randomly evaluated. Number of participants with soft stool will be recorded.

Trial Locations

Locations (1)

Pornanong Aramwit; 🇹🇭 Bangkok, Thailand