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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958866
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

Brief Summary:

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

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acetaminophen
Acetaminophen administer 1000 mg every 4-6 hours when fever is presented
Drug: Acetaminophen
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
Other: Placebo



Primary Outcome Measures :
  1. Body Temperature [ Time Frame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Thailand
Pornanong Aramwit
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University

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Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01958866    
Other Study ID Numbers: 0156
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University:
Fever
Body temperature
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics