NCT05305456

Brief Summary

This study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

March 30, 2022

Last Update Submit

December 5, 2022

Conditions

Novel Coronavirus Pneumonia

Keywords

mild, common

Outcome Measures

Primary Outcomes (1)

  • The time from the first dose to sustained clinical recovery

    Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate

    8 days

Secondary Outcomes (5)

  • Novel coronavirus N and ORF gene changes

    8 days

  • The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization

    8 days

  • Effective rate of wind heat attacking lung syndrome

    8 days

  • Duration of disappearance of main symptoms of wind heat attacking lung syndrome

    8 days

  • Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)

    90 days

Study Arms (2)

Tanreqing capsule

EXPERIMENTAL

3 capsules per time, 3 times a day，7 days of treatment

Drug: Tanreqing capsule

Tanreqing capsule simulator

PLACEBO COMPARATOR

3 capsules per time, 3 times a day，7 days of treatment

Drug: Tanreqing capsule simulator

Interventions

Tanreqing capsuleDRUG

3 capsules per time, 3 times a day

Also known as: Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
Tanreqing capsule
Tanreqing capsule simulatorDRUG

3 capsules per time, 3 times a day

Also known as: Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
Tanreqing capsule simulator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • According to the Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary；
  • Aged greater than 18, with no gender limitation;
  • Symptom score greater than or equal 3 points;
  • Voluntarily accept the drug treatment and sign the informed consent.

You may not qualify if:

  • Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
  • immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
  • pregnant and lactating women;
  • People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
  • mentally ill persons or persons without self-awareness;
  • Patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening;
  • (8) In patients with serious primary diseases of heart, brain, liver and kidney, ALT and AST were 1.5 times higher than the upper limit of normal value; (9) Other conditions that the investigator considers inappropriate for clinical trial participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200093, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

tanreqing

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Zhao Ren, PhD

    Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

March 31, 2022

Study Start

March 28, 2022

Primary Completion

June 2, 2022

Study Completion

August 31, 2022

Last Updated

December 6, 2022

Record last verified: 2022-11

Locations

CN(2)