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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| The Second Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| Red Cross Hospital, Hangzhou, China | OTHER |
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The goal of this clinical trial is to learn if Shenqi Yishen Granules works to treat IgA Nephropathy in adults. It will also learn about the safety of Shenqi Yishen Granules. The main questions it aims to answer are:
Does Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical problems do participants have when taking Shenqi Yishen Granules? Researchers will compare Shenqi Yishen Granules to a placebo (a look-alike substance that contains no drug) to see if Shenqi Yishen Granules works to treat IgA Nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Shenqi Yishen Granules + Irbesartan |
|
| Control Group | Placebo Comparator | Chinese herbal placebo + Irbesartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenqi Yishen Granules | Drug | A traditional Chinese medicine compound for the treatment of IgA nephropathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary protein quantification | 24-hour urinary protein quantification | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| Protein-to-creatinine rati | Concentration of Protein-to-creatinine rati | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cells in urine | Red blood cells in urine | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| Glomerular filtration rate | Glomerular filtration rate |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Potassium | Safety indicators | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| electrocardiogram | Determine whether the patient has experienced adverse cardiac events based on the electrocardiogram |
Inclusion Criteria:
Exclusion Criteria:
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Individual participant data involves the personal privacy of participants and should not be made public or shared.
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Hangzhou Traditional Chinese Medicine Hospital | UNKNOWN |
| Zhenhai District Traditional Chinese Medicine Hospital | UNKNOWN |
| Jiangsu Province Hospital of Traditional Chinese Medicine | OTHER |
| Shao Yifu Hospital of Zhejiang Medical University | UNKNOWN |
| Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry | UNKNOWN |
| Yuyao City Traditional Chinese Medicine Hospital | UNKNOWN |
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| Hangzhou Xiaoshan First People's Hospital | UNKNOWN |
| Shanghai 6th People's Hospital | OTHER |
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| Placebo | Drug | a look-alike substance that contains no drug |
|
|
| 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| The number of infections in the respiratory, gastrointestinal, or urinary tract | The number of infections in the respiratory, gastrointestinal, or urinary tract | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| TCM syndrome score | Assess the patient's clinical symptoms based on the rating scale; the higher the score, the more severe the symptoms. | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| Concentration of Alanine Aminotransferase | Safety indicators | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| Concentration of Glutamic-oxaloacetic transaminase | Security indicators | 0 weeks, 4 weeks, 8 weeks, 12 weeks |
| Concentration of hemoglobin | Security indicators | 0 weeks, 4weeks, 8 weeks, 12 weeks |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |