Viral Haemorrhagic FeverPhase 2NCT01973855
Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms
A Phase 2 study testing Western Medicine and TCM and Western Medicine in people with Viral Haemorrhagic Fever and Dengue Fever, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
To meet eligibility criteria, this study and informed consent of the syndrome of fever associated with bleeding of infectious diseases, severe patients to carry out multicenter, practical randomized controlled clinical research, to compare the curative effect of western medicine, combining Chinese and western medicine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Viral Haemorrhagic Fever, Dengue Fever
- What is being tested?
- Western Medicine and TCM and Western Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2015
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Viral diseases, such as dengue fever, kidney of hemorrhagic fever, such as xinjiang hemorrhagic fever; Or clinical has fever associated with bleeding as the main performance, and confirmed as the new emergent infectious diseases
Who cannot join
- Diagnosed with flu, hand, foot and mouth disease, viral hepatitis (except the carrier), liver cirrhosis after hepatitis, AIDS, rabies, encephalitis, polio, measles, German measles, chickenpox, herpes, infectious mononucleosis, infectious atypical pneumonia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi 'an eighth people's hospital
XiAn, Shanxi, 710000
Xu R Fang, 13008415052, xurongfang@vip.sina.com
About this study
Official title: Syndrome of Fever Associated With Bleeding of Chinese and Western Medicine Diagnosis and Treatment of Infectious Diseases Plans and Severe Clinical Treatment Research
To meet eligibility criteria, this study and informed consent of the syndrome of fever associated with bleeding of infectious diseases, severe patients to carry out multicenter, practical randomized controlled clinical research, to compare the curative effect of western medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese medicine, Chinese medicine prescriptions mechanism research.
Read the detailed description
Randomized method: using large sample, central randomized, parallel comparison of Chinese and western medicine and western medicine group.
- Conditions
- Viral Haemorrhagic Fever, Dengue Fever
- Being tested
- Western Medicine, TCM and Western Medicine
- Medical subject headings
- Hemorrhagic Fevers, Viral, Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western MedicineDrug
Also called Ribavirin,
Physical cooling,Hydrocortisone
TCM and Western MedicineDrug
Also called Second Infectious diseases soup recipe and Ribavirin
Third Infectious diseases soup recipe
| Study group | Role | What they receive |
|---|---|---|
| TCM and Western Medicine | Experimental | TCM and Western Medicine:First Infectious diseases soup recipe,every time a dose,Two times a day;Ribavirin 10-15mg per kg every time Western Medicine：Ribavirin 10-15mg per kg every time Receives: Drug: Western Medicine; Drug: TCM and Western Medicine |
| Western Medicine | Placebo comparator | Western Medicine：Ribavirin 10-15mg per kg every time Receives: Drug: TCM and Western Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Anytime of the clinical trail from 2011.1.1 to 2015.12.30
Secondary outcomes (1)
Safety outcome
With adverse events as the calculation basis
Measured: From 2012.1 to 2015.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Haemorrhagic FeverStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinghua Tan, Guangzhou 8th People's Hospital
- Investigators
- Tan X Hua, Study director, Guangzhou 8th hospitol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973855
- Sponsor's protocol ID
- 2012ZX10004301-003
- Status last verified
- Oct 2013
- First submitted
- 24 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndrome of Fever Associated With Bleeding of Chinese and Western Medicine Diagnosis and Treatment of Infectious Diseases Plans and Severe Clinical Treatment Research
- ClinicalTrials.gov ID
- NCT01973855
- Acronym / sponsor ID
- 2012ZX10004301-003
- Conditions
- Viral Haemorrhagic Fever, Dengue Fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Nov 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.
To meet eligibility criteria, this study and informed consent of the syndrome of fever associated with bleeding of infectious diseases, severe patients to carry out multicenter, practical randomized controlled clinical research, to compare the curative effect of western medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese medicine, Chinese medicine prescriptions mechanism research.
Detailed description
Randomized method: using large sample, central randomized, parallel comparison of Chinese and western medicine and western medicine group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM and Western Medicine | Experimental | Drug: Western Medicine, Drug: TCM and Western MedicineTCM and Western Medicine:First Infectious diseases soup recipe,every time a dose,Two times a day;Ribavirin 10-15mg per kg every time Western Medicine：Ribavirin 10-15mg per kg every time |
| Western Medicine | Placebo comparator | Drug: TCM and Western MedicineWestern Medicine：Ribavirin 10-15mg per kg every time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Viral diseases, such as dengue fever, kidney of hemorrhagic fever, such as xinjiang hemorrhagic fever; Or clinical has fever associated with bleeding as the main performance, and confirmed as the new emergent infectious diseases
Key exclusion criteria (1 listed)
- Diagnosed with flu, hand, foot and mouth disease, viral hepatitis (except the carrier), liver cirrhosis after hepatitis, AIDS, rabies, encephalitis, polio, measles, German measles, chickenpox, herpes, infectious mononucleosis, infectious atypical pneumonia
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 |
|---|---|---|
| Western MedicineAlso: Ribavirin,Physical cooling,Hydrocortisone | Drug | TCM and Western Medicine |
| TCM and Western MedicineAlso: Second Infectious diseases soup recipe and RibavirinThird Infectious diseases soup recipe | Drug | TCM and Western Medicine, Western Medicine |
Primary outcome
Mortality
Time frame: Anytime of the clinical trail from 2011.1.1 to 2015.12.30
1 secondary outcome
Safety outcome
Time frame: From 2012.1 to 2015.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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.
Tan X Hua study director
Guangzhou 8th hospitol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Western Medicine and TCM and Western Medicine in people with Viral Haemorrhagic Fever and Dengue Fever, run by Guangzhou 8th People's Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 1 Nov 2013. 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tan X Hua (13500039656, Gz8htxh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Anytime of the clinical trail from 2011.1.1 to 2015.12.30). 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 1 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.