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

NCT01958866 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2015-03-11

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Tinospora Crispa-extract Product

OTHER

Placebo

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Thailand

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958866 on ClinicalTrials.gov