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Completed

NCT Number: NCT01958866

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

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.

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Key information

Conditions

Patients With Body Temperature Between 37.8-38.5 Body Temperature Changes Fever No Liver and Kidney Problem No Sign of Infection Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pornanong Aramwit

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tinospora Crispa-extract Product

Drug

Acetaminophen

Drug

Placebo

Other

Primary outcomes

  1. Body Temperature

    Time frame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2013
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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