Patients With Body Temperature Between 37.8-38.5Phase 2/3NCT01958866
Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
A Phase 2/3 study testing Tinospora Crispa-extract Product and Acetaminophen in people with Patients With Body Temperature Between 37.8-38.5 and No Sign of Infection, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Body Temperature Between 37.8-38.5, No Sign of Infection, No Liver and Kidney Problem
- What is being tested?
- Tinospora Crispa-extract Product and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Patients With Body Temperature Between 37.8-38.5, No Sign of Infection, No Liver and Kidney Problem
- Being tested
- Tinospora Crispa-extract Product, Acetaminophen, Placebo
- Keywords
- Fever, Body temperature
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinospora Crispa-extract ProductDrug
AcetaminophenDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | Acetaminophen administer 1000 mg every 4-6 hours when fever is presented Receives: Drug: Acetaminophen |
| Tinospora Crispa-extract Product | Experimental | Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented Receives: Drug: Tinospora Crispa-extract Product |
| Placebo | Placebo comparator | Placebo 2 tablets will be administered every 4 hours when fever is presented Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Temperature
Measured: 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
Liver and kidney function will be randomly evaluated. Number of participants with soft stool will be recorded.
Measured: Participants will be followed for the duration of hospital stay (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Body Temperature Between 37.8-38.5Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958866
- Sponsor's protocol ID
- 0156
- Status last verified
- Mar 2015
- First submitted
- 11 Sep 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
- ClinicalTrials.gov ID
- NCT01958866
- Acronym / sponsor ID
- 0156
- Conditions
- Patients With Body Temperature Between 37.8-38.5, No Sign of Infection, No Liver and Kidney Problem
- Keywords
- Fever, Body temperature
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen administer 1000 mg every 4-6 hours when fever is presented |
| Tinospora Crispa-extract Product | Experimental | Drug: Tinospora Crispa-extract ProductTinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 2 tablets will be administered every 4 hours when fever is presented |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinospora Crispa-extract Product | Drug | Tinospora Crispa-extract Product |
| Acetaminophen | Drug | Acetaminophen |
| Placebo | Other | Placebo |
Primary outcome
Body Temperature
Time frame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours
1 secondary outcome
Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine
Time frame: Participants will be followed for the duration of hospital stay (24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tinospora Crispa-extract Product and Acetaminophen in people with Patients With Body Temperature Between 37.8-38.5 and No Sign of Infection, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Temperature (time frame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.