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

C

Chulalongkorn University

Status and phase

Completed
Phase 3
Phase 2

Conditions

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

Treatments

Drug: Tinospora Crispa-extract Product
Drug: Acetaminophen
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

96 participants in 3 patient groups, including a placebo group

Acetaminophen
Active Comparator group
Description:
Acetaminophen administer 1000 mg every 4-6 hours when fever is presented
Treatment:
Drug: Acetaminophen
Tinospora Crispa-extract Product
Experimental group
Description:
Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented
Treatment:
Drug: Tinospora Crispa-extract Product
Placebo
Placebo Comparator group
Description:
Placebo 2 tablets will be administered every 4 hours when fever is presented
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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