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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | Acetaminophen administer 1000 mg every 4-6 hours when fever is presented |
|
| Tinospora Crispa-extract Product | Experimental | Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented |
|
| Placebo | Placebo Comparator | Placebo 2 tablets will be administered every 4 hours when fever is presented |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinospora Crispa-extract Product | Drug |
| ||
| Acetaminophen |
| Measure | Description | Time Frame |
|---|---|---|
| Body Temperature | Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pornanong Aramwit | Bangkok | Bangkok | 10330 | Thailand |
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| Drug |
|
| Placebo | Other |
|
| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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