HealthyNCT00329212
The Pharmacokinetics Study of Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans
An observational study of Healthy, run by Committee on Chinese Medicine and Pharmacy at 1 site in China.
Trial summary
The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- San Huang Xie Jin Tang
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteers about 6~8 persons should be aged from 20 to 35 years old with a body weight between 50~80 kg, no marriage and have a healthy body condition.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Committee on Chinese Medicine and Pharmacy, Department of Health
Taipei, Taiwan
About this study
Official title: Bioequivalence of Bioactive Markers Between Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans
The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction.
- Conditions
- Healthy
- Being tested
- San Huang Xie Jin Tang
- Keywords
- Pharmacokinetics, Bioavailability, Therapeutic Equivalency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
San Huang Xie Jin TangDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Committee on Chinese Medicine and Pharmacy
- Sponsor type
- Other government
- Investigators
- Y C Hou, Professor, Principal investigator, School of Chinese Medicine, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329212
- Sponsor's protocol ID
- CCMP95-RD-010
- Status last verified
- Nov 2006
- First submitted
- 23 May 2006
- Last updated
- 15 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Bioactive Markers Between Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans
- ClinicalTrials.gov ID
- NCT00329212
- Acronym / sponsor ID
- CCMP95-RD-010
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Bioavailability, Therapeutic Equivalency
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Committee on Chinese Medicine and PharmacyOther government
- First posted
- 24 May 2006 (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.
The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The volunteers about 6~8 persons should be aged from 20 to 35 years old with a body weight between 50~80 kg, no marriage and have a healthy body condition.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| San Huang Xie Jin Tang | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Nov 2006.
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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.
Y C Hou, Professor principal investigator
School of Chinese Medicine, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Committee on Chinese Medicine and Pharmacy at 1 site in China.
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 1 inclusion and 0 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 15 Nov 2006. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 15 Nov 2006.