NCT04723524

Brief Summary

The clinical trial is designed to be randomized, double blind, placebo controlled, to evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day comprehensive follow-up. The informed consent form must be signed by the subjects before their participation in the trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
402

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Sep 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

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

September 22, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

January 22, 2021

Last Update Submit

June 16, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

  • Change in Primary symptom (cough)

    A grading symptom from 0-6 will be used to assess the symptom (Cough) where the score will be 0 for No cough, 2 for Intermittent cough, 4 for Cough mildly impacting the daily work and 6 Frequent cough or paroxysmal cough seriously impacting the work and life.

    10th day of treatment.

  • Change in Primary symptom (Fever)

    A grading symptom from 0-6 will be used to assess the improvement of main clinical symptom (Fever) where the score will be 0 for No fever ≤ 37 °C (98.6°F), 2 for body temperature \> 37°C (98.6°F) to ≤ 38°C (100.4°F), 4 for body temperature \> 38°C (100.4°F) to ≤ 39°C (102.2°F) and 6 for body temperature \> 39°C (102.2°F) to ≤ 40°C (104°F).

    10th day of treatment

  • Time for Negative COVID-19 Test

    time for Negative coronavirus (COVID-19) Test on RT-PCR

    2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day

Secondary Outcomes (6)

  • Body temperature

    10 days

  • white blood cells count

    during the 10-day course of treatment

  • C-reactive protein test

    during the 10-day course of treatment

  • ferritin test

    during the 10-day course of treatment

  • Radiology

    during the 10-day course of treatment

  • +1 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

150 Cases, treated with Jinhua Qinggan (JHQG) Granules

Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine

Control group

PLACEBO COMPARATOR

150 Cases, Placebo treated

Other: Placebo Comparator

Interventions

Jinhua Qinggan (JHQG) Granules, Traditional Chinese MedicineCOMBINATION_PRODUCT

Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.

Treatment group
Placebo ComparatorOTHER

Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Between the ages of 18-75 years, both male and female.
  • \) Confirmed Coronavirus infection by real time RT-PCR.
  • \) Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned in 7.1.6).
  • \) The subject has signed the informed consent form;

You may not qualify if:

  • \) Younger than 18 years or older than 75 years.
  • \) Patients with moderate or critical Coronavirus infection confirmed by real time RT-PCR; cases meeting any of the following criteria:
  • Lung lesions
  • Respiratory failure and requiring mechanical ventilation
  • Shock
  • With other organ failure that requires ICU cares.
  • \) Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system (above grade II of cardiac function; ALT \& AST are 1.5 times higher than the normal value; Creatinine above the upper limit of normal value) and mental illness or serious diseases affecting their survival, such as cancer or AIDS;
  • \) With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency.
  • \) Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit (including β2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.)
  • \) Allergic individuals and those who are known to be allergic to experimental drugs
  • \) Pregnant women, lactating women or fertile women who are ready to conceive in 3 months.
  • \) Subject, who has participated in the past 1 month in another clinical study.
  • \) Subjects who are not suitable for the clinical trial based on investigators' judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Karachi, 75270, Pakistan

Location

Related Publications (2)

  • Zhang Q, Cao F, Wang Y, Xu X, Sun Y, Li J, Qi X, Sun S, Ji G, Song B. The efficacy and safety of Jinhua Qinggan granule (JHQG) in the treatment of coronavirus disease 2019 (COVID-19): A protocol for systematic review and meta analysis. Medicine (Baltimore). 2020 Jun 12;99(24):e20531. doi: 10.1097/MD.0000000000020531.

    PMID: 32541475BACKGROUND

  • Shah MR, Fatima S, Khan SN, Ullah S, Himani G, Wan K, Lin T, Lau JYN, Liu Q, Lam DSC. Jinhua Qinggan granules for non-hospitalized COVID-19 patients: A double-blind, placebo-controlled, and randomized controlled trial. Front Med (Lausanne). 2022 Aug 1;9:928468. doi: 10.3389/fmed.2022.928468. eCollection 2022.

    PMID: 35979216DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

jinhua qinggan granulesMedicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Study Officials

  • Muhammad Raza Shah

    CBSCR , ICCBS, University of Karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 25, 2021

Study Start

September 22, 2020

Primary Completion

August 23, 2021

Study Completion

August 23, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)