Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
NCT ID: NCT01958866
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
96 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acetaminophen
Acetaminophen administer 1000 mg every 4-6 hours when fever is presented
Acetaminophen
Tinospora Crispa-extract Product
Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented
Tinospora Crispa-extract Product
Placebo
Placebo 2 tablets will be administered every 4 hours when fever is presented
Placebo
Interventions
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Tinospora Crispa-extract Product
Acetaminophen
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Pornanong Aramwit, Pharm.D., Ph.D
Associate Professor
Locations
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Pornanong Aramwit
Bangkok, Bangkok, Thailand
Countries
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Other Identifiers
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0156
Identifier Type: -
Identifier Source: org_study_id
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