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| ID | Type | Description | Link |
|---|---|---|---|
| 2023YFE0198400 | Other Grant/Funding Number | Ministry of Science and Technology of the People´s Republic of China |
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| Name | Class |
|---|---|
| Institute of Chemistry - Vietnam Academy of Science and Technology | UNKNOWN |
| Beijing Ditan Hospital | OTHER |
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The goal of this clinical trial is to learn if Shengmai liquid works to treat Long Covid fatigue. It will also learn about the safety of Shengmai liquid. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shengmai Liquid | Experimental | For patients with Long COVID characterized by persistent fatigue who meet the inclusion and exclusion criteria, 100 patients will be randomly divided into a Shengmaiyin treatment group and a placebo control group using a random method. The Shengmaiyin treatment group will be given the traditional Chinese medicine Shengmaiyin oral liquid (produced by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with the approval number Z41021384. Ingredients: Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, excipients: sucrose, sodium benzoate, ethylparaben, specification 10m1/bottle), taken orally at a dose of 10ml per time, three times a day |
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| Placebo | Placebo Comparator | The placebo group will be given a simulated Shengmaiyin oral liquid (provided by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with main ingredients water, brown sugar, flavoring agents, etc., specification 10m/bottle), 10ml per time, three times a day. The treatment course for Shengmaiyin or placebo will be 8 weeks (56 days), with follow-up continuing until 30 days after the end of the treatment course. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shengmai Liquid | Drug | The Shengmaiyin treatment group will be given the traditional Chinese medicine Shengmaiyin oral liquid (produced by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with the approval number Z41021384. Ingredients: Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, excipients: sucrose, sodium benzoate, ethylparaben, specification 10m1/bottle), taken orally at a dose of 10ml per time, three times a day |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS) | MFIS is a standardized questionnaire reflecting physical and mental fatigue, consisting of 21 questions. Each question has five options (none at all, a little, sometimes, often, almost always), with a total score range of 0 to 84. The higher the score, the higher the degree of chronic fatigue. | From enrollment to the end of follow up at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese Medicine Syndrome Score Scale | Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements. | From enrollment to the end of treatment at 8 week |
| Improvement in depression, assessed using the 17-item Hamilton Depression Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huijuan Cao, Professor | Contact | 0086 +13466615885 | huijuancao327@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Di Tan Hospital, , Capital Medical University | Recruiting | Beijing | China | 102488 | China |
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| Placebo | Other | A simulated Shengmaiyin oral liquid (provided by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with main ingredients water, brown sugar, flavoring agents, etc., specification 10m/bottle), 10ml per time, three times a day. The treatment course for Shengmaiyin or placebo will be 8 weeks (56 days), with follow-up continuing until 30 days after the end of the treatment course. |
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Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements. |
| From enrollment to the end of treatment at 8 weeks |
| Improvement in anxiety, assessed using the Hamilton Anxiety Scale (HAMA) | Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements. | From enrollment to the end of treatment at 8 weeks |
| Improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) | Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements. | From enrollment to the end of treatment at 8 week |
| Improvement in quality of life, assessed using the World Health Organization Quality of Life Scale | measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements. | From enrollment to the end of treatment at 8 weeks |
| six minute walk test(6MWT) | Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements. | From enrollment to the end of treatment at 8 weeks |