Parkinson‘s Disease
Conditions
Interventions
experimental group:Sodium Oligomannate capsule
control group:placebo
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
Male
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30 to 75 years male and female; 2. The clinical diagnosis conforms to the diagnosis criteria of Parkinson's disease established by the International dyskinesia Association (MDS) in 2015; 3. Modified Hoehn-Yahr is 1-3 stage((if anti-PD drugs have been used, the "off" period is 1-3); 4. Female patients must meet the following condition: (1) menopause (defined as at least 2 year without menstruation); (2) surgical sterilization; (3) if have fertility, must meet: 1) pregnancy test performed must be negative within 7 days prior to enrollment; 2) agree to use appropriate contraception (including at least one method) throughout the trial period; 3) do not breastfeed; 5. Male patients must agree to use appropriate contraception (including at least one method); 6. The patient and/or his/her guardian have agreed to participate in the clinical trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1.Known or suspected patients who are allergic to or have severe adverse reaction to the ingredients of the preparation, or allergy; 2.Various secondary Parkinson's syndrome (including drugs, cerebrovascular diseases, encephalitis, hydrocephalus, brain tumors, etc.), Parkinson's superposition syndrome (multiple system atrophy, progressive supranuclear paralysis, cortical basal ganglia syndrome, Lewis body disease), and other non-primary Parkinson's disease (including, but not limited to, Wilson disease, Huntington chorea, Fahr disease, etc); 3.Laboratory examination: ALT, AST > 1.5 times normal value upper limit, SCr > 1.5 times normal value upper limit, WBC, PLT, Hb lower than normal lower limit, blood glucose > 1.5 times normal value upper limit. 4.Patients who have received deep brain stimulation or embryonic tissue transplantation; 5.Patients who have had surgery or plan to have surgery during the experiment for treatment to Parkinson's Disease; 6.Patients with the following cardiovascular and cerebrovascular conditions: (1) heart disease occurred within 6 months, including congestive heart failure , angina pectoris , angina pectoris or myocardial infarction these are greater severity than grade ii-iv of the New York heart association; (2) ventricular arrhythmia that need to receive antiarrhythmic drugs; QTc > 470 ms; hypertension that is not well controlled (systolic >150mmHg or diastolic > 100mmHg); (3) thrombotic or embolic venous or arterial events occurred within 6 months before the enrollment, such as cerebrovascular accidents, including transient ischemic attack, stroke, arterial thrombosis, deep venous thrombosis and pulmonary embolism; 7.Patents judged by researchers to be mentally abnormal; 8.Acute attack of the disease, such as active gastric bleeding and asthma attack; 9.Patients infected with HIV, syphilis, HCV or HBV, or have severe infections requiring systemic treatment with antibiotics; 10.Patients who are receiving active treatment for CNS disorders (e.g., sedatives, sleeping pills, antidepressants, anti-anxiety medications), unless the drug dose has been stable for at least 28 days prior to enrollment and may remain stable for the duration of the study; 11.Other neurological diseases, including neuromyelitis optica, Alzheimer's disease, epilepsy; 12.Patients with tumor or history of tumor; 13.Patients with liver and kidney diseases of clinical significance; 14.Patients who drink heavy, or prone to drug abuse within 5 years; 15.Patients who have previously used Ganlute sodium capsule or participated in the clinical study of Ganlute sodium capsule; 16.Use of heparin, Propylene Glycol Mannurate Sulfate or Alginric Sodium Diester within 3 weeks prior to screening; 17.Patients who disobey the doctor's advice; 18.Patients with any diseases unstable or might compromise patient safety and compliance with the study; 19.Attended other intervention clinical trial within 30 days or during the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UPDRS;Diversity and abundance of intestinal flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hoehn-Yahr;Non-motor symptom related scales (NMSS, CSI, AHRS, FSS, MoCA, PDQ-39, HAMD, HAMA);Plasma inflammation and metabolic biomarkers; | — |
Countries
China
Contacts
Public ContactJin Lingjing
Shanghai Tongji Hospital
Outcome results
None listed