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

NCT01958866 | Completed Phase 2 DMC

• 1 other identifier: 0156
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Fever; Body temperature

Outcome Measures

Primary Outcomes (1)

• Body Temperature

  Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours

Secondary Outcomes (1)

• Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine

  Participants will be followed for the duration of hospital stay (24 hours)

Study Arms (3)

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen administer 1000 mg every 4-6 hours when fever is presented

Drug: Acetaminophen

Tinospora Crispa-extract Product

EXPERIMENTAL

Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented

Drug: Tinospora Crispa-extract Product

Placebo

PLACEBO COMPARATOR

Placebo 2 tablets will be administered every 4 hours when fever is presented

Other: Placebo

Interventions

Tinospora Crispa-extract Product DRUG

Tinospora Crispa-extract Product

Acetaminophen DRUG

Acetaminophen

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Pornanong Aramwit

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: October 9, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

TH (1)