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

March 10, 2015 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Pornanong Aramwit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetaminophen
Acetaminophen administer 1000 mg every 4-6 hours when fever is presented
Drug: Acetaminophen
Experimental: Tinospora Crispa-extract Product
Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented
Drug: Tinospora Crispa-extract Product
Placebo Comparator: Placebo
Placebo 2 tablets will be administered every 4 hours when fever is presented
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Temperature
Time Frame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours
Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine
Time Frame: 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.
Participants will be followed for the duration of hospital stay (24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patients With Body Temperature Between 37.8-38.5

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe