Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
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|ClinicalTrials.gov Identifier: NCT01958866|
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : March 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Body Temperature Between 37.8-38.5 No Sign of Infection No Liver and Kidney Problem||Drug: Tinospora Crispa-extract Product Drug: Acetaminophen Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Acetaminophen
Acetaminophen administer 1000 mg every 4-6 hours when fever is presented
Experimental: Tinospora Crispa-extract Product
Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented
Drug: Tinospora Crispa-extract Product
Placebo Comparator: Placebo
Placebo 2 tablets will be administered every 4 hours when fever is presented
- Body Temperature [ Time Frame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958866
|Bangkok, Thailand, 10330|