ColdPhase 2NCT03089138

Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome

A Phase 2 study testing Regan Tangjiang in people with Cold, run by Beijing Da-an Bio-technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cold
What is being tested?: Regan Tangjiang
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: No sites listed yet
Study dates: Mar 2017to Mar 2018
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

Diagnosis of common cold according to Western Medicine，with symptoms onset and fever less than 24 hours prior to randomization；
After the onset of the disease, with the following symptoms: sore throat and axillary temperature between 38.5 and 38.9°C inclusive.
Diagnosis of wind-heat syndrome according to TCM；
Aged between 18 to 65 years；
Willingness to participate and to sign the informed consent form.

Who cannot join

Participants with Pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute and chronic sinusitis, pulmonary tuberculosis and other diseases;
White blood cell count >11.0×109/L, or neutrophil percentage>75%;
Participants with liver function 1.5 times higher than the normal upper limit or serum creatinine higher than the normal upper limit;
Participants with severe primary diseases of cardiovascular, brain, lung, liver, kidney and hematopoietic system , such as viral hepatitis, hemophilia, diabetes, psychosis and so on;
Participants who had used other drugs to treat common cold after the onset of the disease, including antivirals, antibiotics and traditional Chinese medicine.
Women who are pregnant or breast-feeding;

Show all 9Show fewer

Allergic condition (refer to history of allergy to two or more drugs or food) or allergy to the drug composition(s);
Participation in another clinical study of an investigational drug within 3 months
Participants who are not suitable for the trial decided by the researchers for any reason, such as pregnancy, frequently changes in work or living environments.

About this study

Official title: Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study

Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study

Conditions: Cold
Being tested: Regan Tangjiang
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regan TangjiangDrug
The treatment duration is 3 consecutive days.

Study groups in NCT03089138
Study group	Role	What they receive
Regan Tangjiang，Simulation Shufengjiere Capsules	Experimental	Not described Receives: Drug: Regan Tangjiang
Simulation Regan Tangjiang，Shufengjiere Capsules	Active comparator	Not described Receives: Drug: Regan Tangjiang
Simulation Regan Tangjiang and Shufengjiere Capsules	Placebo comparator	Not described Receives: Drug: Regan Tangjiang

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to fever relief
The median time from the first dosing to time when the body temperature drops by at least 0.5℃.In this study, all patients will be required to record their body temperature in the patient diary every 2 hours within the first 12 hours and every 4 hours during the following 12 hours. After that, it should be recorded four times at a fixed time every day.
Measured: day 1 to day 3

Secondary outcomes (5)

Time to fever clearance
The median time from the first dose administration to the time when the body temperature drops below 37.3℃ and lasts for 24 hours.
Measured: day 1 to day 3
Time to symptom disappearance
The median time from study enrollment to the time when each individual symptom （such as fever, pharyngalgia, headache, runny nose, blocked nose, sneezing, cough） completely disappear.
Measured: day 1 to day 3
Disappearance rate of symptoms
The percentage of patients with each individual symptom completely disappear from study enrollment to three days treatments.
Measured: day 1 to day 3
Efficacy in TCM symptom and sign scores
The TCM symptom scoring system used in the study follows the Guidelines for Clinical Research of New Chinese Medicine, in which all symptoms are graded.
Measured: day 1 to day 3
Usage of emergency medicines
Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol).
Measured: day 1 to day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2017Mar 2018

First posted24 Mar 2017
Study startMar 2017 (estimated)
Primary completionMar 2018 (estimated)
Study completionMar 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ColdStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03089138
Sponsor's protocol ID: regan tangjiang phase 2
Status last verified: Mar 2017
First submitted: 13 Mar 2017
Last updated: 24 Mar 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis

All Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study
ClinicalTrials.gov ID: NCT03089138
Acronym / sponsor ID: regan tangjiang phase 2
Conditions: Cold
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Beijing Da-an Bio-technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: Mar 2017 (estimated)
Primary completion: Mar 2018 (estimated)
Study completion: Mar 2018 (estimated)
First posted: 24 Mar 2017 (actual)
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.

Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Regan Tangjiang，Simulation Shufengjiere Capsules	Experimental	Drug: Regan Tangjiang
Simulation Regan Tangjiang，Shufengjiere Capsules	Active comparator	Drug: Regan Tangjiang
Simulation Regan Tangjiang and Shufengjiere Capsules	Placebo comparator	Drug: Regan Tangjiang

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of common cold according to Western Medicine，with symptoms onset and fever less than 24 hours prior to randomization；
After the onset of the disease, with the following symptoms: sore throat and axillary temperature between 38.5 and 38.9°C inclusive.
Diagnosis of wind-heat syndrome according to TCM；
Aged between 18 to 65 years；
Willingness to participate and to sign the informed consent form.

Key exclusion criteria (9 listed)

Participants with Pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute and chronic sinusitis, pulmonary tuberculosis and other diseases;
White blood cell count >11.0×109/L, or neutrophil percentage>75%;
Participants with liver function 1.5 times higher than the normal upper limit or serum creatinine higher than the normal upper limit;
Participants with severe primary diseases of cardiovascular, brain, lung, liver, kidney and hematopoietic system , such as viral hepatitis, hemophilia, diabetes, psychosis and so on;
Participants who had used other drugs to treat common cold after the onset of the disease, including antivirals, antibiotics and traditional Chinese medicine.

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
Regan TangjiangThe treatment duration is 3 consecutive days.	Drug	Regan Tangjiang，Simulation Shufengjiere Capsules, Simulation Regan Tangjiang and Shufengjiere Capsules, Simulation Regan Tangjiang，Shufengjiere Capsules

Primary outcome

Time to fever relief
Time frame: day 1 to day 3
The median time from the first dosing to time when the body temperature drops by at least 0.5℃.In this study, all patients will be required to record their body temperature in the patient diary every 2 hours within the first 12 hours and every 4 hours during the following 12 hours. After that, it should be recorded four times at a fixed time every day.

5 secondary outcomes

Time to fever clearance
Time frame: day 1 to day 3
Time to symptom disappearance
Time frame: day 1 to day 3
Disappearance rate of symptoms
Time frame: day 1 to day 3
Efficacy in TCM symptom and sign scores
Time frame: day 1 to day 3
Usage of emergency medicines
Time frame: day 1 to day 3

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Individual participant dataSharing planned: Undecided

Related trials for Cold

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regan Tangjiang in people with Cold, run by Beijing Da-an Bio-technology Co., Ltd..

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 9 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Time to fever relief (time frame: day 1 to day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03089138.

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 24 Mar 2017.