COVID-19 PandemicNCT05228873
Comparison of Quality of Life After Discharge of the Mild and Moderate COVID-19 Patients With or Without Herbal Medicine
An observational study of COVID-19 Pandemic and Quality of Life, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The purpose of this study is to see how the acute stage COVID-19 treatments by use of herbal medicine (Shen Cao Gan Jiang Tang) affect quality of life and symptoms at 3 months after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- COVID-19 Pandemic, Quality of Life
- What is being tested?
- Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Dec 2021to 20 Jan 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 64 years
- All sexes
- Adult
Study population: The mild and moderate COVID-19 patients who used the Shen Cao Gan Jiang Tang in the acute phase
Who may be able to join
- Patients able to understand and fill out a questionnaire
- From full 18 to 64 years old;
- Patients with the mild and moderate COVID-19 who used Shen Cao Gan Jiang Tang in the acute phase for intervention group.
- Participants enrolled in protocol NCT05055427.
- Voluntarily consented to participate in the study
Who cannot join
- Patient who are not able to complete 100% of the questionnaire Criteria for stopping the study
- The patient cannot be contacted after 04 calls, each call is at least 06 hours apart on the survey days.
- The patient does not want to continue participating in the study.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Comparison of Quality of Life 3 Months After Discharge of the Mild and Moderate COVID-19 Patients With or Without Herbal Medicine (Shen Cao Gan Jiang Tang) in the Acute Stage
The purpose of this study is to see how the acute stage COVID-19 treatments by use of herbal medicine (Shen Cao Gan Jiang Tang) affect quality of life and symptoms at 3 months after hospital discharge.
Read the detailed description
According to the theory of Traditional medicine, the patient will suffer damage to Qi and Fluid in the acute phase and lead to damaged Yin and Qi in the post COVID-19 period.
The Shen Cao Gan Jiang Tang has the effect of enhance the Protective Qi, generating Fluid, is applied to treat the mild and moderate COVID-19 in the acute phase in some hospitals in Ho Chi Minh City, Viet Nam. The hypothesis is that with the use of the Shen Cao Gan Jiang Tang, the Qi and Yin will reduce the damage, so that the patient has a better quality of life and fewer post COVID-19 symptoms compared with the standard of care group
- Conditions
- COVID-19 Pandemic, Quality of Life
- Being tested
- Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)Drug
Also called Sâm Thảo Can khương thang (Cam thảo Can khương thang gia Nhân sâm) - Vietnamese name
Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days. Ingredients per formula (tang): 12 grams of honey-fried Radix Glycyrrhizae, 6 grams of Rhizoma Zingiberis (stir-baked), 6 grams of Panax Ginseng. The decoction of concentrated extract is packed into aluminum foil vacuum bag, 90ml per bag, 1 formula (tang) is equivalent to 2 bags. Patients use the decoction directly from the bag.
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days plus the Standard of Care (SOC) for the treatment of COVID-19 acute stage based on the Vietnam Ministry of Health guideline at this time Receives: Drug: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) | |
| • Controlled arm | Patient who receive the Standard of Care (SOC) for the treatment of COVID-19 acute stage based on the Vietnam Ministry of Health guideline at this time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL) questionnaire
Data will be collected by using the 36-Item Short Form Survey (SF-36) QoL instruments at 3 months after hospital discharge.
Measured: 3 months
Secondary outcomes (1)
Post COVID-19 symptoms
Number of patients (%) have the post COVID-19 symptoms at 3 months after hospital discharge. The post COVID-19 symptoms have included cough, shortness of breath, fatigue, headache, attention disorder, hair loss, loss of smell, loss of taste, rapid breathing after activity, joint pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start20 Dec 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NGUYEN VAN DAN, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Nguyen Van Dan, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228873
- Sponsor's protocol ID
- 838-9/HĐĐĐ-ĐHYD
- Status last verified
- Jul 2023
- First submitted
- 5 Feb 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Life 3 Months After Discharge of the Mild and Moderate COVID-19 Patients With or Without Herbal Medicine (Shen Cao Gan Jiang Tang) in the Acute Stage
- ClinicalTrials.gov ID
- NCT05228873
- Acronym / sponsor ID
- 838-9/HĐĐĐ-ĐHYD
- Conditions
- COVID-19 Pandemic, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 8 Feb 2022 (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.
The purpose of this study is to see how the acute stage COVID-19 treatments by use of herbal medicine (Shen Cao Gan Jiang Tang) affect quality of life and symptoms at 3 months after hospital discharge.
Detailed description
According to the theory of Traditional medicine, the patient will suffer damage to Qi and Fluid in the acute phase and lead to damaged Yin and Qi in the post COVID-19 period.
The Shen Cao Gan Jiang Tang has the effect of enhance the Protective Qi, generating Fluid, is applied to treat the mild and moderate COVID-19 in the acute phase in some hospitals in Ho Chi Minh City, Viet Nam. The hypothesis is that with the use of the Shen Cao Gan Jiang Tang, the Qi and Yin will reduce the damage, so that the patient has a better quality of life and fewer post COVID-19 symptoms compared with the standard of care group
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | – | Drug: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days plus the Standard of Care (SOC) for the treatment of COVID-19 acute stage based on the Vietnam Ministry of Health guideline at this time |
| • Controlled arm | – | –Patient who receive the Standard of Care (SOC) for the treatment of COVID-19 acute stage based on the Vietnam Ministry of Health guideline at this time |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- The mild and moderate COVID-19 patients who used the Shen Cao Gan Jiang Tang in the acute phase
Key inclusion criteria (5 listed)
- Patients able to understand and fill out a questionnaire
- From full 18 to 64 years old;
- Patients with the mild and moderate COVID-19 who used Shen Cao Gan Jiang Tang in the acute phase for intervention group.
- Participants enrolled in protocol NCT05055427.
- Voluntarily consented to participate in the study
Key exclusion criteria (3 listed)
- Patient who are not able to complete 100% of the questionnaire Criteria for stopping the study
- The patient cannot be contacted after 04 calls, each call is at least 06 hours apart on the survey days.
- The patient does not want to continue participating in the study.
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 |
|---|---|---|
| Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)Also: Sâm Thảo Can khương thang (Cam thảo Can khương thang gia Nhân sâm) - Vietnamese namePatients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days. Ingredients per formula (tang): 12 grams of honey-fried Radix Glycyrrhizae, 6 grams of Rhizoma Zingiberis (stir-baked), 6 grams of Panax Ginseng. The decoction of concentrated extract is packed into aluminum foil vacuum bag, 90ml per bag, 1 formula (tang) is equivalent to 2 bags. Patients use the decoction directly from the bag. | Drug | Investigational arm |
Primary outcome
Quality of Life (QoL) questionnaire
Time frame: 3 months
Data will be collected by using the 36-Item Short Form Survey (SF-36) QoL instruments at 3 months after hospital discharge.
1 secondary outcome
Post COVID-19 symptoms
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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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.
Nguyen Van Dan principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Quality of Life, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 3 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: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life (QoL) questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.