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

NCT ID: NCT01958866

Last Updated: 2015-03-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Acetaminophen

Acetaminophen administer 1000 mg every 4-6 hours when fever is presented

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Tinospora Crispa-extract Product

Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented

Group Type EXPERIMENTAL

Tinospora Crispa-extract Product

Intervention Type DRUG

Placebo

Placebo 2 tablets will be administered every 4 hours when fever is presented

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Tinospora Crispa-extract Product

Intervention Type DRUG

Acetaminophen

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pornanong Aramwit

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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0156

Identifier Type: -

Identifier Source: org_study_id

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