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

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

NCT01958866

0156

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

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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