Efficacy and safety of Suhuang Zhike capsule (苏黄止咳胶囊) for cough variant asthma: a multicenter, single-arm, open-label phase IV real-world clinical trial

doi:10.19852/j.cnki.jtcm.2025.04.011

Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (4): 817-828.DOI: 10.19852/j.cnki.jtcm.2025.04.011

• Original Articles • Previous Articles Next Articles

Efficacy and safety of Suhuang Zhike capsule (苏黄止咳胶囊) for cough variant asthma: a multicenter, single-arm, open-label phase IV real-world clinical trial

ZHANG Hongchun¹, LIU Jian¹, CHEN Sheng², ZHANG Wei³, LU Xuechao⁴, LI Ying¹, YU Xueqing⁵, HUANG Yan⁶, SU Lianhua⁷, WEI Baolin⁸, LI Zhuyin⁹, PEI Shuai¹⁰, LEI Xiang¹¹, YANG Daowen¹, GUO Jianning¹()

1 Department of Traditional Chinese Medicine for Pulmonary Diseases, National Center for Respiratory Medicine; National Centre for Integrative Chinese and Western Medicine; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; China-Japan Friendship Hospital, Beijing 100029, China
2 Department of Respiratory Diseases, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen 518033, China
3 Department of Pulmonary and Critical Care Medicine, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan 250011, China
4 Department of Respiratory and Critical Care Medicine, Qingdao Hospital of Traditional Chinese Medicine (Qingdao Hiser Hospital), Qingdao 266033, China
5 Department of Pulmonary Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China
6 Department of Pulmonary Diseases, Inner Mongolia Autonomous Region Traditional Chinese Medicine Hospital, Hohhot 750306, China
7 Department of Pulmonary Diseases, Fangshan Hospital Beijing University of Chinese Medicine, Beijing 102488, China
8 Department of Pulmonary Diseases, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China
9 Department of Pulmonary Diseases, the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China
10 Marketing Department of Yangzijiang Pharmaceutical Group Co., Ltd., Taizhou 225300, China
11 Medical Department, Beijing Qi-Huang Technology Co., Ltd., Beijing 100006, China

Received:2024-12-22 Accepted:2025-05-18 Online:2025-08-15 Published:2025-07-25
Contact: GUO Jianning
About author:GUO Jianning, Department of Traditional Chinese Medicine for Pulmonary Diseases, National Center for Respiratory Medicine; National Centre for Integrative Chinese and Western Medicine; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; China-Japan Friendship Hospital, Beijing 100029, China. Dr.jane93@outlook.com,Telephone: +86-15319537768
First author contact:
ZHANG Hongchun and LIU Jian are co-first authors and contributed equally to this work
Supported by:
Inheritance and Innovation of Traditional Chinese Medicine "Hundred Million" Talent Project (Qihuang Project)(2019-QTL-003)

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Abstract

Abstract:

OBJECTIVE: To summarize the clinical efficacy characteristics of Suhuang Zhike capsule (苏黄止咳胶囊) and evaluate the incidence of adverse reactions in its broad clinical application.

METHODS: This was a multicenter, prospective, single-arm, open-label phase IV clinical trial. A total of 1100 patients diagnosed with cough variant asthma (CVA) and the Traditional Chinese Medicine (TCM) syndrome of wind evil invading the lung and lung Qi failing to propagate were planned for recruitment. Participants received Suhuang Zhike capsule orally, three capsules per dose, taken three times daily, for a treatment duration of 14 d. The primary outcome was the change in cough symptom scores from baseline to week 2. Cough severity was assessed twice daily. Additional evaluations included the rate and time of cough disappearance or basic disappearance rate, as well as the time of cough relief. TCM symptom scores were recorded at baseline and on days 7 and 14 of treatment. Safety assessments included monitoring for adverse events and conducting laboratory tests.

RESULTS: A total of 1033 patients with CVA from 40 hospitals across China were enrolled in the study. Of these, 1026 patients received the study medication and were included in the safety analysis. Fifty-four patients withdrew from the study, resulting in a drop-out rate of 5.23%. Treatment with Suhuang Zhike capsules significantly reduced cough symptom scores and improved cough-related symptoms in patients with CVA. The overall rate of cough disappearance or basic disappearance increased over the course of treatment, reaching 67.21% after 14 d. The median time of cough relief was 3 d, while the median time to cough disappearance or basic disappearance was 11 d. Additionally, the treatment led to reductions in TCM symptom scores and improvements in accompanying symptoms such as throat itching, expectoration, and shortness of breath. In terms of safety, no serious adverse events were reported. The incidence of related adverse events (AEs) was 2.24% (23 cases, 30 events). The incidence of adverse reactions listed in the drug’s instructions was 2.14%. Other related AEs not listed in the drug’s instructions occurred in 0.39% of patients and included dizziness (0.19%), headache (0.10%), pruritus (0.10%), and palpitation (0.10%).

CONCLUSION: Suhuang Zhike capsules demonstrated good efficacy and safety for the treatment of CVA. These findings offer valuable clinical evidence to support their broader application in routine clinical practice.

Key words: cough-variant asthma, treatment outcome, safety, Suhuang Zhike capsule

ZHANG Hongchun, LIU Jian, CHEN Sheng, ZHANG Wei, LU Xuechao, LI Ying, YU Xueqing, HUANG Yan, SU Lianhua, WEI Baolin, LI Zhuyin, PEI Shuai, LEI Xiang, YANG Daowen, GUO Jianning. Efficacy and safety of Suhuang Zhike capsule (苏黄止咳胶囊) for cough variant asthma: a multicenter, single-arm, open-label phase IV real-world clinical trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(4): 817-828.

Figures/Tables 10

References 27.

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Characteristic		FAS (n =1033)
Age (years)	$\bar{x} \pm s$	43.59±15.71
	Median (Q1, Q3)	44.00 (29.00, 57.00)
	Min, Max	17.00, 88.00
Gender [n (%)]	Male	346 (33.53)
Gender [n (%)]	Female	686 (66.47)
Ethnic [n (%)]	Han	1009 (97.77)
Ethnic [n (%)]	Minority	23 (2.23)
Height (cm, $\bar{x} \pm s$)		165.71±7.09
Weight (kg, $\bar{x} \pm s$)		63.97±10.21
Body temperature (℃, $\bar{x} \pm s$)		36.42±0.22
Pulse (Times/min, $\bar{x} \pm s$)		74.93±9.33
Respiratory rates (Times/min, $\bar{x} \pm s$)		18.09±1.55
Diastolic blood pressure (mm Hg, $\bar{x} \pm s$)		76.25±8.53
Systolic pressure (mm Hg, $\bar{x} \pm s$)		119.72±11.16
Positive bronchial provocation test [n (%)]	Yes	31 (3.00)
Positive bronchial provocation test [n (%)]	No	1002 (97.00)
Positive bronchi relaxation test [n (%)]	Yes	11 (1.06)
Positive bronchi relaxation test [n (%)]	No	1022 (98.94)
The average variability of PEF > 10% [n (%)]	Yes	0 (0.00)
The average variability of PEF > 10% [n (%)]	No	1033 (100.00)
History of diseases [n (%)]	Yes	244 (23.62)
History of diseases [n (%)]	No	789 (76.38)
Allergic history [n (%)]	Yes	59 (5.71)
Allergic history [n (%)]	No	974 (94.29)
Anti-asthma treatment was effective [n (%)]	Yes	71 (6.87)
Anti-asthma treatment was effective [n (%)]	No	962 (93.13)
Chest X-ray inspection results [n (%)]	Normal	578 (55.95)
	Abnormal	452 (43.76)
	Not performed	2 (0.19)
	Missing	1 (0.10)

Characteristic		FAS (n =1033)
Age (years)	$\bar{x} \pm s$	43.59±15.71
	Median (Q1, Q3)	44.00 (29.00, 57.00)
	Min, Max	17.00, 88.00
Gender [n (%)]	Male	346 (33.53)
Gender [n (%)]	Female	686 (66.47)
Ethnic [n (%)]	Han	1009 (97.77)
Ethnic [n (%)]	Minority	23 (2.23)
Height (cm, $\bar{x} \pm s$)		165.71±7.09
Weight (kg, $\bar{x} \pm s$)		63.97±10.21
Body temperature (℃, $\bar{x} \pm s$)		36.42±0.22
Pulse (Times/min, $\bar{x} \pm s$)		74.93±9.33
Respiratory rates (Times/min, $\bar{x} \pm s$)		18.09±1.55
Diastolic blood pressure (mm Hg, $\bar{x} \pm s$)		76.25±8.53
Systolic pressure (mm Hg, $\bar{x} \pm s$)		119.72±11.16
Positive bronchial provocation test [n (%)]	Yes	31 (3.00)
Positive bronchial provocation test [n (%)]	No	1002 (97.00)
Positive bronchi relaxation test [n (%)]	Yes	11 (1.06)
Positive bronchi relaxation test [n (%)]	No	1022 (98.94)
The average variability of PEF > 10% [n (%)]	Yes	0 (0.00)
The average variability of PEF > 10% [n (%)]	No	1033 (100.00)
History of diseases [n (%)]	Yes	244 (23.62)
History of diseases [n (%)]	No	789 (76.38)
Allergic history [n (%)]	Yes	59 (5.71)
Allergic history [n (%)]	No	974 (94.29)
Anti-asthma treatment was effective [n (%)]	Yes	71 (6.87)
Anti-asthma treatment was effective [n (%)]	No	962 (93.13)
Chest X-ray inspection results [n (%)]	Normal	578 (55.95)
	Abnormal	452 (43.76)
	Not performed	2 (0.19)
	Missing	1 (0.10)

Outcome	Number [n (missing case)]	Full-day cough symptom score ($\bar{x} \pm s$)	Change vs Baseline ($\bar{x} \pm s$)	P value
Baseline	1026 (0)	3.8±1.3	-	-
2 d of treatment	1013 (13)	3.4±1.4	—0.4±1.2	<0.0001
3 d of treatment	1011 (15)	3.2±1.3	—0.7±1.3	<0.0001
4 d of treatment	1009 (17)	2.9±1.3	—1.0±1.3	<0.0001
5 d of treatment	1007 (19)	2.5±1.3	—1.3±1.3	<0.0001
6 d of treatment	1006 (20)	2.3±1.2	—1.6±1.3	<0.0001
7 d of treatment	1002 (24)	2.1±1.1	—1.8±1.4	<0.0001
8 d of treatment	989 (37)	2.1±1.1	—1.8±1.4	<0.0001
9 d of treatment	981 (45)	2.0±1.1	—1.9±1.4	<0.0001
10 d of treatment	979 (47)	1.7±1.1	—2.1±1.4	<0.0001
11 d of treatment	977 (49)	1.4±1.1	—2.4±1.5	<0.0001
12 d of treatment	950 (76)	1.2±1.1	—2.6±1.6	<0.0001
13 d of treatment	912 (114)	1.1±1.1	—2.8±1.6	<0.0001
14 d of treatment	771 (255)	0.9±1.1	—2.9±1.7	<0.0001

Outcome	Number [n (missing case)]	Full-day cough symptom score ($\bar{x} \pm s$)	Change vs Baseline ($\bar{x} \pm s$)	P value
Baseline	1026 (0)	3.8±1.3	-	-
2 d of treatment	1013 (13)	3.4±1.4	—0.4±1.2	<0.0001
3 d of treatment	1011 (15)	3.2±1.3	—0.7±1.3	<0.0001
4 d of treatment	1009 (17)	2.9±1.3	—1.0±1.3	<0.0001
5 d of treatment	1007 (19)	2.5±1.3	—1.3±1.3	<0.0001
6 d of treatment	1006 (20)	2.3±1.2	—1.6±1.3	<0.0001
7 d of treatment	1002 (24)	2.1±1.1	—1.8±1.4	<0.0001
8 d of treatment	989 (37)	2.1±1.1	—1.8±1.4	<0.0001
9 d of treatment	981 (45)	2.0±1.1	—1.9±1.4	<0.0001
10 d of treatment	979 (47)	1.7±1.1	—2.1±1.4	<0.0001
11 d of treatment	977 (49)	1.4±1.1	—2.4±1.5	<0.0001
12 d of treatment	950 (76)	1.2±1.1	—2.6±1.6	<0.0001
13 d of treatment	912 (114)	1.1±1.1	—2.8±1.6	<0.0001
14 d of treatment	771 (255)	0.9±1.1	—2.9±1.7	<0.0001

Time of treatment (day)	Cough disappearance rate (%, 95% CI)
2	5.23 (3.94, 6.79)
3	8.11 (6.50, 9.97)
4	11.02 (9.16, 13.12)
5	15.44 (13.26, 17.82)
6	17.43 (15.13, 19.92)
7	16.68 (14.41, 19.16)
8	19.73 (17.28, 22.37)
9	24.69 (22.02, 27.52)
10	36.09 (33.08, 39.19)
11	47.08 (43.91, 50.27)
12	56.38 (53.15, 59.56)
13	63.76 (60.53, 66.89)
14	67.21 (63.70, 70.58)

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Efficacy and safety of Suhuang Zhike capsule (苏黄止咳胶囊) for cough variant asthma: a multicenter, single-arm, open-label phase IV real-world clinical trial

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Figures/Tables 10

References 27.

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Full-day cough symptom score	Suhuang Zhike capsule	Combined respiratory system Western Medicine	P value
Baseline	3.6±1.4	2.9±1.4	<0.0001
2 d of treatment	3.5±1.4	2.9±1.5	<0.0001
3 d of treatment	3.2±1.3	2.7±1.4	0.0014
4 d of treatment	2.9±1.3	2.4±1.4	0.0003
5 d of treatment	2.6±1.2	2.2±1.3	0.0026
6 d of treatment	2.3±1.2	2.0±1.3	0.0223
7 d of treatment	2.1±1.1	1.8±1.2	0.0264
8 d of treatment	2.1±1.1	1.7±1.1	0.0027
9 d of treatment	2.0±1.0	1.9±1.2	0.4051
10 d of treatment	1.7±1.1	1.6±1.2	0.3457
11 d of treatment	1.4±1.1	1.5±1.2	0.5501
12 d of treatment	1.2±1.1	1.4±1.3	0.1290
13 d of treatment	1.0±1.1	1.3±1.2	0.0344
14 d of treatment	0.9±1.1	1.3±1.2	0.0026

Time of treatment (day)	Cough disappearance/basic disappearance rate (%, 95% CI)	The effective time to cough relief rate (%, 95% CI)
0	0.00 (0)	0.00 (0)
1	4.46 (3.35, 5.93)	29.78 (27.07, 32.70)
2	5.95 (4.65, 7.59)	38.31 (35.40, 41.38)
3	9.13 (7.50, 11.08)	51.25 (48.20, 54.37)
4	12.61 (10.71, 14.82)	62.44 (59.45, 65.43)
5	17.39 (15.18, 19.87)	72.15 (69.35, 74.89)
6	21.28 (18.88, 23.95)	79.75 (77.20, 82.18)
8	28.93 (26.23, 31.85)	86.83 (84.64, 88.85)
10	43.96 (40.93, 47.11)	91.09 (89.18, 92.79)
12	64.13 (61.12, 67.13)	93.96 (92.30, 95.37)
14	74.72 (71.91, 77.46)	95.90 (94.45, 97.06)
Delete loss rate (%)	28.27	7.21

Item	Events (n)	Patients (n)	Incidence rate (%)
All AEs	213	125	12.18
Related AEs	30	23	2.24
Important AEs	42	32	3.12
Serious AEs	3	3	0.29
Serious related AEs	0	0	0
AEs leading to dropout	8	5	0.49

Related AEs	Events (n)	Patients (n)	Incidence rate (%)
Total	30	23	2.24
Gastrointestinal diseases	22	20	1.95
Abdominal discomfort	9	9	0.88
Nausea	8	8	0.78
Emesis	2	2	0.19
Constipation	1	1	0.10
Fecal abnormality	1	1	0.10
Dry mouth	1	1	0.10
Various nervous system diseases	3	3	0.29
Dizzy	2	2	0.19
Headache	1	1	0.10
Diseases of respiratory system, chest and mediastinu	3	3	0.29
Dry throat	3	3	0.29
Diseases of the skin and subcutaneous tissue	1	1	0.10
pruritus	1	1	0.10
Heart organ disease	1	1	0.10
Palpitation	1	1	0.10

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