MG Granules Improve COVID-19 Efficacy and Safety of Convalescent Exercise Tolerance
Manzhi Guben Granules Improve Novel Coronavirus Infection (COVID-19) Efficacy and Safety of Convalescent Exercise Tolerance -- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
1 other identifier
interventional
360
0 countries
N/A
Brief Summary
The global coronavirus pandemic has infected nearly 659 million people and killed more than 6.6 million in the past three years. The symptoms of in-hospital recovery are long and difficult after epidemiological infection of 2019-NCo5. 76% of the 1,733 discharged patients in Wuhan in 2020 still had at least one symptom of discomfort 6 months after infection, with fatigue or muscle weakness being the most common (63%). Foreign Research: In the United States, 15 percent of 16,091 people infected with COVID-19 in 2021 had symptoms that persisted two months after infection. Novel Coronavirus Infection Diagnosis and Treatment Protocol (Trial 10th Edition) For patients recovering from novel coronavirus infection, TCM syndrome differentiation can be carried out according to the Guidelines for Home-based TCM Intervention for Patients Infected with Novel Coronavirus, and appropriate TCM prescriptions should be given for intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Jun 2023
Longer than P75 for not_applicable covid19
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
First Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
February 10, 2023
February 1, 2023
3 years
February 8, 2023
February 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Results of 6 min walking test on day 14
Results of 6 min walking test on day 14 after treatment
14 days
Secondary Outcomes (2)
Results of 6 min walking test on the 28
28 days
Pulmonary ventilation function on day 14 and 28
14 days and 28 days
Study Arms (2)
Manzi Guben granules
EXPERIMENTALAdministration cycle of Manzhi Guben granules: 1-4 weeks; Usage: 10g once, twice a day, washed with boiling water.
placebo group
PLACEBO COMPARATORAdministration cycle of Manzhi Guben granules simulator: 1-4 weeks; Usage: 10g once, twice a day, washed with boiling water.
Interventions
Administration cycle of Manzhi Guben granules: 1-4 weeks; Usage: 10g once, twice a day, washed with boiling water.
Eligibility Criteria
You may qualify if:
- Diagnostic criteria for convalestion-phase of COVID-19 patients: Patients with COVID-19 have entered the convalestion-phase when they meet any of the following criteria and other symptoms improve: 1) two consecutive negative nucleic acid tests with Ct values ≥35; 2) The antigen test results were negative for three consecutive days; 3) After staying at home for 7 days, the fever has subsided for more than 24 hours without using antipyretic drugs; (2) Middle-aged and elderly outpatients aged 50-80 (including 50 and 80 years old), regardless of gender; (3) The main clinical manifestations were fatigue, shortness of breath, cough (satisfying at least two main symptoms), and the results of 6-minute walking test were less than 80% of the predicted value (about 450-500 meters); Can be accompanied by poor puppie full, loose stool, light fat tongue, thin white or thin greasy moss, pulse floating, the performance of lung qi deficiency. (4) Voluntarily participate in this clinical study, give informed consent and sign informed consent.
You may not qualify if:
- Severe and critically ill hospitalized patients with novel coronavirus infection; (2) accompanied by tumor, immune deficiency disease; (3) The researcher thinks that it is not appropriate to participate in this clinical research; (4) Suspected or confirmed history of alcohol and drug abuse; (5) Known or suspected allergic history to the study drug and its excipients; (6) participated in other clinical investigators within 3 months before screening; (7) Patients with severe neurological, cardiac, pulmonary, hematopoietic, endocrine, musculoskeletal motor system and other primary diseases and mental disorders; (8) Patients with clinical manifestations of Yin deficiency and fire flourishing (red tongue and thin pulse) or phlegm-dampness and lung stagnation (white and greasy moss, slippery pulse strings); (9) Life expectancy is less than 12 weeks due to underlying diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
yongan xu, doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 10, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
February 10, 2023
Record last verified: 2023-02