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Safety and efficacy of Shaoma Zhijing granule in the treatment of tic disorder in children: a multicenter phase IV clinical trial

Safety and efficacy of Shaoma Zhijing granule in the treatment of tic disorder in children: a multicenter phase IV clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005755
Enrollment
Unknown
Registered
2022-03-23
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tic Disorder

Interventions

Shaoma Zhijing granule:take orally

Sponsors

Jiangsu Hospital of traditional Chinese Medicine, Beijing Anding Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria of Western medicine for tic disorder in children, including Tourette syndrome and chronic tic disorder; 2.TCM syndrome differentiation belongs to the syndrome of liver hyperactivity, wind movement and internal disturbance of phlegm and fire; 3.Age = 5 years old and = 18 years old, regardless of gender; 4.The guardians of the children agree to participate in this study and sign the informed consent form. At the same time, the children = 8 years old need to sign the informed consent form together.

Exclusion criteria

Exclusion criteria: 1. Complicated with serious diseases such as heart, brain, liver, kidney or hematopoietic system; Children with clinically significant ECG abnormalities assessed by the investigator; 2. Abnormal liver and kidney function (ALT or AST = 1.2 times the upper limit of normal value, Cr > the upper limit of normal value); 3. Children who have been clearly diagnosed as depression and schizophrenia at the time of screening; 4. Chinese and Western drugs regularly used for the treatment of tic disorder in children within the first two weeks of screening; 5. Children allergic to Shaoma Zhijing granule and its components; 6. The researcher considers it inappropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
YGTSS;

Secondary

MeasureTime frame
TCM syndrome curative effect;

Countries

China

Contacts

Public ContactHan Xinmin, Zheng Yi

Jiangsu Hospital of traditional Chinese Medicine, Beijing Anding Hospital Affiliated to Capital Medical University

yizheng@ccmu.edu.cn010-86430066

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026