No Liver and Kidney Problem Clinical Trial
| Verified date | March 2015 |
| Source | Chulalongkorn University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 96 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Pornanong Aramwit | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Chulalongkorn University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Body Temperature | Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours | No | |
| Secondary | 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) | Yes |