Neuromyelitis optica/Neuromyelitis optica spectrum disorders
Conditions
Interventions
Treatment group:Lingnan herbal medicine combined with spleen-tonifying and kidney-nourishing traditional Chinese medicine plus Western medicine treatment
Sponsors
Shenzhen Traditional Chinese Medicine Hospital
The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 80 years, both genders are eligible; (2) Participants who have not participated in other clinical studies or new drug trials during the study period; (3) Diagnosed according to the diagnostic criteria of "Diagnosis and Treatment Guidelines for Neuromyelitis Optica Spectrum Disorders" in China in 2016, and for AQP-4 antibody-negative NMOSD, other onset causes must be fully excluded; (4) Traditional Chinese medicine diagnosis criteria: Referring to the diagnostic criteria of spleen and kidney yang deficiency and dampness obstruction in Zhu Wenfeng's "Zhen Su Bian Zheng Xue"; (5) Participants voluntarily participate in the clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Symptoms caused by non-NMOSD that affect the implementation of corresponding treatment measures in this study; (2) Symptoms or manifestations that may affect the evaluation of scales such as EDSS, such as severe aphasia, uncontrollable active mental illness, etc.; (3) Remission periods of other demyelinating diseases of the central nervous system, such as multiple sclerosis; (4) Inability to complete relevant examinations required by the study; (5) Refusal to participate in the study or to sign the informed consent form; (6) Other patients who are deemed unable to complete the observation period; (7) Exclusion of patients with severe cardiac or pulmonary dysfunction, liver or kidney failure, unstable vital signs, and those with severe pulmonary infections, urinary tract infections, or bedsores that may affect follow-up in the later stages.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expanded Disability Status Scale, EDSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale, mRS;annual relapse rate, ARR;Distribution of gut microbiota; | — |
Countries
China
Contacts
Public ContactFanxin Kong
Shenzhen Traditional Chinese Medicine Hospital The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Outcome results
None listed