Clinical efficacy evaluation of Jingxin Zhidong recipe in the treatment of children with tic disorder and its correlation with allergic indexes

Not Applicable

• Conditions: Tic Disorder (TD)

• Registration Number: ITMCTR2100005032
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. TD group inclusion criteria:
(1) Outpatients attending the Department of Pediatrics, Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences;
(2) Meet the diagnostic criteria of TD western medicine and traditional Chinese medicine, and aged 6-16 years;
(3) Patients with no history of chorea, athetosis, autism, hepatolenticular degeneration, childhood schizophrenia, epilepsy, drug-induced, tardive dyskinesia, hysteria or acute dyskinesia;
(4) Those who have not suffered from autoimmune diseases or rheumatic diseases in the past three months;
(5) The patient has not taken immune enhancement or inhibitor, allergic transmitter blocker or antagonistic drugs in the past year.
2 Inclusion criteria for the healthy group:
(1) Children undergoing physical examination at Guang'anmen Hospital of China Academy of Chinese Medical Sciences;
(2) Aged between 6 and 16 years;
(3) No history of exogenous disease in the past two weeks;
(4) No immune enhancement or inhibitor, allergic transmitter blocker or antagonist drug has been taken in the past year.

Exclusion Criteria

1. TD group exclusion criteria:
(1) Those who refuse to sign the informed consent;
(2) Abnormal maternal pregnancy and birth history;
(3) The main indicators of liver and kidney function and urine routine test report are abnormal;
(4) Those who cannot accept oral Chinese medicine;
(5) Those who participate in other clinical trials at the same time.
2. Exclusion criteria for healthy group:
(1) Those who refuse to sign the informed consent;
(2) Abnormal maternal pregnancy and birth history;
(3) Those with abnormal main indicators returned by physical examination of liver and kidney function and urine routine test.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Yale comprehensive tic severity scale;

Secondary Outcome Measures

Name	Time	Method
ISAAC scale;