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

Study Overview
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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

Intervention / Treatment
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* Drug: Tinospora Crispa-extract Product
* Drug: Acetaminophen
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Temperature |  | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever, Body temperature