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

NCT03089138 | Unknown Phase 2

• 1 other identifier: regan tangjiang phase 2
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cold

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1 to day 3

Secondary Outcomes (5)

• Time to fever clearance

  day 1 to day 3

• Time to symptom disappearance

  day 1 to day 3

• Disappearance rate of symptoms

  day 1 to day 3

• Efficacy in TCM symptom and sign scores

  day 1 to day 3

• Usage of emergency medicines

  day 1 to day 3

Study Arms (3)

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

Interventions

Regan Tangjiang DRUG

The treatment duration is 3 consecutive days.

Regan Tangjiang，Simulation Shufengjiere Capsules; Simulation Regan Tangjiang and Shufengjiere Capsules; Simulation Regan Tangjiang，Shufengjiere Capsules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Beijing Da-an Bio-technology Co., Ltd.: lead

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 24, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 24, 2017

Record last verified: 2017-03