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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01958866

Enrollment

Registered

2013-10-09

Start date

2013-10-31

Completion date

2014-12-31

Last updated

2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No Liver and Kidney Problem, No Sign of Infection, Patients With Body Temperature Between 37.8-38.5

Keywords

Fever, Body temperature

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.

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.

Interventions

DRUGTinospora Crispa-extract Product

DRUGAcetaminophen

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Body Temperature	Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours

Secondary

Measure	Time frame	Description
Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine	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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026