Journal of Traditional Chinese Medicine ›› 2023, Vol. 43 ›› Issue (1): 134-139.DOI: 10.19852/j.cnki.jtcm.2023.01.012
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Effectiveness and safety of Jinshuibao capsules (金水宝胶囊) in treatment of residual cardiopulmonary symptoms in convalescent patients of coronavirus disease 2019: a pilot randomized, double-blind, placebo-controlled clinical trial
ZHANG Yuehong1, DONG Dandan2, YAN Youqin2, ZHANG Hao3, WANG Guangli2, ZHOU Wei2, LI Wei2, QIU Li2, LI Tingming2, LIU Quan3, XIA Ping4, MAO Lina4, YANG Danlin2, YANG Lu3, LIAN Fengmei1, TONG Xiaolin1(
), BA Yuanming3()
- 1 Department of Endocrinology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
2 Department of Infectious Diseases, Wuhan No.7 Hospital, Wuhan 430071, China
3 Department of Electrocardiograms, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China
4 Department of Orthopaedics, Wuhan No.1 Hospital, Wuhan 430061, China; Department of Respiratory, Wuhan No.1 Hospital, Wuhan 430061, China
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Received:2022-01-26Accepted:2022-04-12Online:2023-02-15Published:2023-01-10 -
Contact:TONG Xiaolin,BA Yuanming -
About author:Prof. BA Yuanming, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China. 1723426138@qq.com. Telephone:+86-27-87748195; +86-13986179621
Prof. TONG Xiaolin, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100053, China. tongxiaolin66@sina.com;
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Supported by:A Randomized, Double Blinded, Controlled, Multicenter Clinical Trial to Improve the Symptoms of Pulmonary and Cardiac Function During the Convalescence of COVID-19(2020ZYLCYJ08-3);National Key R&D Program(2020YFC0845000);The State Administration of Traditional Chinese Medicine Special Project of Chinese Medicine Emergency Response to New Coronavirus Pneumonia(2020ZYLCYJ04-1)
Cite this article
ZHANG Yuehong, DONG Dandan, YAN Youqin, ZHANG Hao, WANG Guangli, ZHOU Wei, LI Wei, QIU Li, LI Tingming, LIU Quan, XIA Ping, MAO Lina, YANG Danlin, YANG Lu, LIAN Fengmei, TONG Xiaolin, BA Yuanming. Effectiveness and safety of Jinshuibao capsules (金水宝胶囊) in treatment of residual cardiopulmonary symptoms in convalescent patients of coronavirus disease 2019: a pilot randomized, double-blind, placebo-controlled clinical trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(1): 134-139.
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Figure 1 Flow diagram of participant screening, randomization, and treatment PPS: per-protocol set.
Figure 1 Flow diagram of participant screening, randomization, and treatment PPS: per-protocol set.
Table 1 Demographic and clinical characteristics
| Characteristic | Jinshuibao group (n = 97) | Control group (n = 95) | P value | |
|---|---|---|---|---|
| Age (years) | 55.04±10.51 | 53.27±10.64 | 0.248 | |
| Sex (male/female) (n) | 51/46 | 57/38 | 0.300 | |
| BMI (kg/m2) | 23.53±2.44 | 23.10±2.72 | 0.248 | |
| Smoking (yes/no) | 21/76 | 14/81 | 0.215 | |
| Drinking (yes/no) | 24/73 | 16/79 | 0.178 | |
| Clinical types [n (%)] | Light type | 13 (13.40) | 15 (15.79) | 0.889 |
| Common type | 73 (75.26) | 69 (72.63) | ||
| Heavy type | 11 (11.34) | 11 (11.58) | ||
| Heart rate (beat/min) | 82.77±11.87 | 83.19±12.62 | 0.814 | |
| Respiratory rate (beat/min) | 18.39±1.40 | 18.28±1.36 | 0.590 | |
| SBP (mm Hg) [n (%)] | ≥90, <140 | 77 (79.38) | 81 (85.26) | 0.446 |
| ≥140, <160 | 17 (17.53) | 13 (13.68) | ||
| ≥160, <180 | 3 (3.09) | 1 (1.05) | ||
| DBP (mm Hg) [n (%)] | <60 | 4 (4.12) | 3 (3.16) | 0.720 |
| ≥60, <90 | 77 (79.38) | 82 (86.32) | ||
| ≥90, <100 | 11 (11.34) | 8 (8.42) | ||
| ≥100, <110 | 3 (3.09) | 1 (1.05) | ||
| ≥110 | 2(2.06) | 1 (1.05) | ||
| Body temperature (℃) | 36.35±0.17 | 36.38±0.20 | 0.435 | |
Table 1 Demographic and clinical characteristics
| Characteristic | Jinshuibao group (n = 97) | Control group (n = 95) | P value | |
|---|---|---|---|---|
| Age (years) | 55.04±10.51 | 53.27±10.64 | 0.248 | |
| Sex (male/female) (n) | 51/46 | 57/38 | 0.300 | |
| BMI (kg/m2) | 23.53±2.44 | 23.10±2.72 | 0.248 | |
| Smoking (yes/no) | 21/76 | 14/81 | 0.215 | |
| Drinking (yes/no) | 24/73 | 16/79 | 0.178 | |
| Clinical types [n (%)] | Light type | 13 (13.40) | 15 (15.79) | 0.889 |
| Common type | 73 (75.26) | 69 (72.63) | ||
| Heavy type | 11 (11.34) | 11 (11.58) | ||
| Heart rate (beat/min) | 82.77±11.87 | 83.19±12.62 | 0.814 | |
| Respiratory rate (beat/min) | 18.39±1.40 | 18.28±1.36 | 0.590 | |
| SBP (mm Hg) [n (%)] | ≥90, <140 | 77 (79.38) | 81 (85.26) | 0.446 |
| ≥140, <160 | 17 (17.53) | 13 (13.68) | ||
| ≥160, <180 | 3 (3.09) | 1 (1.05) | ||
| DBP (mm Hg) [n (%)] | <60 | 4 (4.12) | 3 (3.16) | 0.720 |
| ≥60, <90 | 77 (79.38) | 82 (86.32) | ||
| ≥90, <100 | 11 (11.34) | 8 (8.42) | ||
| ≥100, <110 | 3 (3.09) | 1 (1.05) | ||
| ≥110 | 2(2.06) | 1 (1.05) | ||
| Body temperature (℃) | 36.35±0.17 | 36.38±0.20 | 0.435 | |
Table 2 Symptom scores at baseline and after one and two weeks of treatment
| Symptom | Jinshuibao group | Control group | P value |
|---|---|---|---|
| Dry cough | n = 50 | n = 46 | |
| Baseline | 4.00 (2.75, 5.00) | 4.00 (3.00, 4.25) | 0.913 |
| 1 week | 2.00 (1.75, 3.00) | 3.00 (2.00, 4.00) | 0.175 |
| 2 weeks | 0 (0, 2.00) | 2.00 (2.00, 3.25) | <0.001a |
| Shortness of breath | n = 95 | n = 91 | |
| Baseline | 5.00 (4.00, 6.00) | 5.00 (4.00, 6.00) | 0.768 |
| 1 week | 4.00 (3.00, 5.00) | 4.00 (3.00, 5.00) | 0.724 |
| 2 weeks | 3.00 (1.00, 4.00) | 3.00 (2.00, 5.00) | 0.001a |
| Sweating | n = 75 | n = 71 | |
| Baseline | 6.00 (3.00, 7.00) | 4.00 (2.00, 6.00) | 0.019a |
| 1 week | 4.00 (2.00, 6.00) | 3.00 (2.00, 5.00) | 0.082 |
| 2 weeks | 2.00 (0, 4.00) | 3.00 (2.00, 4.00) | 0.041a |
| Chest tightness | n = 85 | n = 86 | |
| Baseline | 5.00 (3.00, 6.00) | 4.00 (3.00, 6.00) | 0.580 |
| 1 week | 3.00 (2.00, 4.00) | 4.00 (3.00, 5.00) | 0.200 |
| 2 weeks | 2.00 (0, 3.00) | 3.00 (2.00, 4.00) | < 0.001a |
| Palpitation | n = 80 | n = 79 | |
| Baseline | 4.00 (3.00, 6.00) | 4.00 (2.00, 5.00) | 0.110 |
| 1 week | 3.00 (2.00, 5.00) | 3.00 (2.00, 4.00) | 0.846 |
| 2 weeks | 1.00 (0, 3.00) | 2.00 (0, 3.00) | 0.070 |
Table 2 Symptom scores at baseline and after one and two weeks of treatment
| Symptom | Jinshuibao group | Control group | P value |
|---|---|---|---|
| Dry cough | n = 50 | n = 46 | |
| Baseline | 4.00 (2.75, 5.00) | 4.00 (3.00, 4.25) | 0.913 |
| 1 week | 2.00 (1.75, 3.00) | 3.00 (2.00, 4.00) | 0.175 |
| 2 weeks | 0 (0, 2.00) | 2.00 (2.00, 3.25) | <0.001a |
| Shortness of breath | n = 95 | n = 91 | |
| Baseline | 5.00 (4.00, 6.00) | 5.00 (4.00, 6.00) | 0.768 |
| 1 week | 4.00 (3.00, 5.00) | 4.00 (3.00, 5.00) | 0.724 |
| 2 weeks | 3.00 (1.00, 4.00) | 3.00 (2.00, 5.00) | 0.001a |
| Sweating | n = 75 | n = 71 | |
| Baseline | 6.00 (3.00, 7.00) | 4.00 (2.00, 6.00) | 0.019a |
| 1 week | 4.00 (2.00, 6.00) | 3.00 (2.00, 5.00) | 0.082 |
| 2 weeks | 2.00 (0, 4.00) | 3.00 (2.00, 4.00) | 0.041a |
| Chest tightness | n = 85 | n = 86 | |
| Baseline | 5.00 (3.00, 6.00) | 4.00 (3.00, 6.00) | 0.580 |
| 1 week | 3.00 (2.00, 4.00) | 4.00 (3.00, 5.00) | 0.200 |
| 2 weeks | 2.00 (0, 3.00) | 3.00 (2.00, 4.00) | < 0.001a |
| Palpitation | n = 80 | n = 79 | |
| Baseline | 4.00 (3.00, 6.00) | 4.00 (2.00, 5.00) | 0.110 |
| 1 week | 3.00 (2.00, 5.00) | 3.00 (2.00, 4.00) | 0.846 |
| 2 weeks | 1.00 (0, 3.00) | 2.00 (0, 3.00) | 0.070 |
Table 3 Improvement value of symptom scores after one and two weeks of treatment
| Symptom | Jinshuibao group | Control group | P value |
|---|---|---|---|
| Dry cough | n = 50 | n = 46 | |
| 1 week | 1.00 (0, 2.00) | 0.50 (0, 2.00) | 0.277 |
| 2 weeks | 2.50 (1.00, 4.00) | 1.00 (0, 2.00) | 0.001a |
| Shortness of breath | n = 95 | n = 91 | |
| 1 week | 1.00 (0, 2.00) | 1.00 (0, 1.00) | 0.044a |
| 2 weeks | 2.00 (2.00, 3.00) | 1.00 (0, 2.00) | < 0.001a |
| Sweating | n = 75 | n = 71 | |
| 1 week | 1.00 (0, 2.00) | 1.00 (0, 2.00) | 0.440 |
| 2 weeks | 3.00 (2.00, 5.00) | 2.00 (0, 3.00) | < 0.001a |
| Chest tightness | n = 85 | n = 86 | |
| 1 week | 1.00 (0, 2.00) | 0 (0, 1.00) | 0.001a |
| 2 weeks | 3.00 (2.00, 4.00) | 2.00 (0, 2.00) | < 0.001a |
| Palpitation | n = 80 | n = 79 | |
| 1 week | 1.00 (0, 2.00) | 1.00 (0, 1.00) | 0.006a |
| 2 weeks | 3.00 (2.00, 4.00) | 2.00 (1.00, 3.00) | < 0.001a |
Table 3 Improvement value of symptom scores after one and two weeks of treatment
| Symptom | Jinshuibao group | Control group | P value |
|---|---|---|---|
| Dry cough | n = 50 | n = 46 | |
| 1 week | 1.00 (0, 2.00) | 0.50 (0, 2.00) | 0.277 |
| 2 weeks | 2.50 (1.00, 4.00) | 1.00 (0, 2.00) | 0.001a |
| Shortness of breath | n = 95 | n = 91 | |
| 1 week | 1.00 (0, 2.00) | 1.00 (0, 1.00) | 0.044a |
| 2 weeks | 2.00 (2.00, 3.00) | 1.00 (0, 2.00) | < 0.001a |
| Sweating | n = 75 | n = 71 | |
| 1 week | 1.00 (0, 2.00) | 1.00 (0, 2.00) | 0.440 |
| 2 weeks | 3.00 (2.00, 5.00) | 2.00 (0, 3.00) | < 0.001a |
| Chest tightness | n = 85 | n = 86 | |
| 1 week | 1.00 (0, 2.00) | 0 (0, 1.00) | 0.001a |
| 2 weeks | 3.00 (2.00, 4.00) | 2.00 (0, 2.00) | < 0.001a |
| Palpitation | n = 80 | n = 79 | |
| 1 week | 1.00 (0, 2.00) | 1.00 (0, 1.00) | 0.006a |
| 2 weeks | 3.00 (2.00, 4.00) | 2.00 (1.00, 3.00) | < 0.001a |
Table 4 Symptom improvement and full recovery rates [n (%)]
| Symptom | Jinshuibao group | Control group | P value | |||
|---|---|---|---|---|---|---|
| Dry cough | n = 50 | n = 46 | ||||
| 1 week | Symptom improvement | 22 (44.00) | 17 (36.96) | 0.483 | ||
| Full recovery | 10 (20.00) | 7 (15.22) | 0.540 | |||
| 2 weeks | Symptom improvement | 37 (74.00) | 23 (50.00) | 0.015a | ||
| Full recovery | 29 (58.00) | 9 (19.57) | < 0.001a | |||
| Shortness of breath | n = 95 | n = 91 | ||||
| 1 week | Symptom improvement | 33 (34.74) | 28 (30.77) | 0.565 | ||
| Full recovery | 3 (3.16) | 1 (1.10) | 0.333 | |||
| 2 weeks | Symptom improvement | 75 (78.95) | 42 (46.15) | < 0.001a | ||
| Full recovery | 18 (18.95) | 7 (7.69) | 0.024a | |||
| Sweating | n = 75 | n = 71 | ||||
| 1 week | Symptom improvement | 31 (41.33) | 30 (42.25) | 0.910 | ||
| Full recovery | 4 (5.33) | 8 (11.27) | 0.192 | |||
| 2 weeks | Symptom improvement | 60 (80.00) | 41 (57.75) | 0.004a | ||
| Full recovery | 27 (36.00) | 14 (19.72) | 0.029a | |||
| Chest tightness | n = 85 | n = 86 | ||||
| 1 week | Symptom improvement | 35 (41.18) | 22 (25.58) | 0.031a | ||
| Full recovery | 4 (4.71) | 2 (2.33) | 0.398 | |||
| 2 weeks | Symptom improvement | 74 (87.06) | 52 (60.47) | <0.001a | ||
| Full recovery | 28 (32.94) | 12 (13.95) | 0.003a | |||
| Palpitation | n = 80 | n = 79 | ||||
| 1 week | Symptom improvement | 36 (45.00) | 26 (32.91) | 0.118 | ||
| Full recovery | 5 (5.25) | 5 (6.33) | 0.984 | |||
| 2 weeks | Symptom improvement | 66 (82.50) | 51 (64.56) | 0.010a | ||
| Full recovery | 39 (48.75) | 23 (29.11) | 0.011a | |||
Table 4 Symptom improvement and full recovery rates [n (%)]
| Symptom | Jinshuibao group | Control group | P value | |||
|---|---|---|---|---|---|---|
| Dry cough | n = 50 | n = 46 | ||||
| 1 week | Symptom improvement | 22 (44.00) | 17 (36.96) | 0.483 | ||
| Full recovery | 10 (20.00) | 7 (15.22) | 0.540 | |||
| 2 weeks | Symptom improvement | 37 (74.00) | 23 (50.00) | 0.015a | ||
| Full recovery | 29 (58.00) | 9 (19.57) | < 0.001a | |||
| Shortness of breath | n = 95 | n = 91 | ||||
| 1 week | Symptom improvement | 33 (34.74) | 28 (30.77) | 0.565 | ||
| Full recovery | 3 (3.16) | 1 (1.10) | 0.333 | |||
| 2 weeks | Symptom improvement | 75 (78.95) | 42 (46.15) | < 0.001a | ||
| Full recovery | 18 (18.95) | 7 (7.69) | 0.024a | |||
| Sweating | n = 75 | n = 71 | ||||
| 1 week | Symptom improvement | 31 (41.33) | 30 (42.25) | 0.910 | ||
| Full recovery | 4 (5.33) | 8 (11.27) | 0.192 | |||
| 2 weeks | Symptom improvement | 60 (80.00) | 41 (57.75) | 0.004a | ||
| Full recovery | 27 (36.00) | 14 (19.72) | 0.029a | |||
| Chest tightness | n = 85 | n = 86 | ||||
| 1 week | Symptom improvement | 35 (41.18) | 22 (25.58) | 0.031a | ||
| Full recovery | 4 (4.71) | 2 (2.33) | 0.398 | |||
| 2 weeks | Symptom improvement | 74 (87.06) | 52 (60.47) | <0.001a | ||
| Full recovery | 28 (32.94) | 12 (13.95) | 0.003a | |||
| Palpitation | n = 80 | n = 79 | ||||
| 1 week | Symptom improvement | 36 (45.00) | 26 (32.91) | 0.118 | ||
| Full recovery | 5 (5.25) | 5 (6.33) | 0.984 | |||
| 2 weeks | Symptom improvement | 66 (82.50) | 51 (64.56) | 0.010a | ||
| Full recovery | 39 (48.75) | 23 (29.11) | 0.011a | |||
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