Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
10.19540/j.cnki.cjcmm.20241212.501
- Author:
Qiu-Han CAI
1
;
Cheng-Liang ZHONG
1
;
Si-Yuan HU
1
;
Xin-Min LI
1
;
Zhi-Chun XU
2
;
Hui CHEN
3
;
Ying HUA
4
;
Jun-Hong WANG
5
;
Ji-Hong TANG
6
;
Bing-Xiang MA
7
;
Xiu-Xia WANG
8
;
Ai-Zhen WANG
9
;
Meng-Qing WANG
10
;
Wei ZHANG
11
;
Chun WANG
12
;
Yi-Qun TENG
13
;
Yi-Hui SHAN
14
;
Sheng-Xuan GUO
11
Author Information
1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300381, China National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300381, China.
2. Daqing People's Hospital Daqing 246004, China.
3. the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300250, China.
4. Wuxi Children's Hospital Wuxi 214023, China.
5. Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
6. Children's Hospital of Soochow University Suzhou 215025, China.
7. the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450003, China.
8. the Second Hospital of Hebei Medical University Shijiazhuang 050061, China.
9. Taizhou Hospital of Traditional Chinese Medicine Taizhou 225700, China.
10. the First Hospital of Hunan University of Chinese Medicine Changsha 410000, China.
11. First Affiliated Hospital, Heilongjiang University of Chinese Medicine Harbin 150040, China.
12. Deyang People's Hospital Deyang 618199, China.
13. the Second Hospital of Jiaxing Jiaxing 314000, China.
14. the Third Hospital of Daqing Daqing 163712, China.
- Publication Type:Multicenter Study
- Keywords:
Jiuwei Xifeng Granules;
Os Draconis;
Ostreae Concha;
equivalence trial;
randomized controlled trial
- MeSH:
Adolescent;
Child;
Child, Preschool;
Female;
Humans;
Male;
Double-Blind Method;
Drugs, Chinese Herbal/therapeutic use*;
Tic Disorders/drug therapy*;
Treatment Outcome
- From:
China Journal of Chinese Materia Medica
2025;50(6):1699-1705
- CountryChina
- Language:Chinese
-
Abstract:
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
