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A prospective, randomized, double-blind, placebo-controlled, multicenter,human-experience clinical study of the efficacy and safety of Stop Trembling Tang Granules in the treatment of mild-to-moderate Parkinson's Disease with Liver and Kidney deficiency

A prospective, randomized, double-blind, placebo-controlled, multicenter,human-experience clinical study of the efficacy and safety of Stop Trembling Tang Granules in the treatment of mild-to-moderate Parkinson's Disease with Liver and Kidney deficiency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077038
Enrollment
Unknown
Registered
2023-10-27
Start date
2023-10-27
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Parkinson

Interventions

Trial group: Zhichan granules, 1 packet each time, twice a day
control groups:Zhichan Granules Analog, 1 packet each time, 2 times daily.

Sponsors

Affiliated Traditional Chinese Medicine Hospital of Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria for Parkinson's disease; (2) Those aged 40 to 70 years; (3) Those whose condition is below grade 3 (including grade 3) according to the modified Hoehn-Yahr grading method; (4) Those who meet the diagnostic criteria for liver and kidney insufficiency in Chinese medicine; (5) Those with TCM evidence score =10; (6) Those with Parkinson's Disease Non-Motor Symptom Scale score NMSS >40; (7) Those who signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who had undergone surgery such as deep electrical stimulation in the six months prior to the trial; (2) Those with severe hypertension (blood pressure >180/120) with unsatisfactory control; (3) Psychiatric disorders, epilepsy, pregnant and lactating women; (4) Those who have combined severe cerebrovascular disease and have limb dysfunction caused by cerebrovascular disease; (5) Those with severe heart failure, renal failure, abnormal liver function, bone and joint diseases, etc., which affect the evaluation of the efficacy of this disease; (6) Alcoholism, drug addiction or severe intellectual impairment (including severe dementia), those who cannot take medication on time and those who cooperate with the examination; (7) Participants in other clinical trials within the last 2 months; (8) Patients with Parkinson's syndrome and Parkinson's superimposed sign; (9) Allergic and allergic to the known ingredients of the test drug and the control drug. (10) Severe depression HAMD-17 >24 and Insomnia Severity Index Scale (ISI) >21.

Design outcomes

Primary

MeasureTime frame
MDS-UPDRS;

Secondary

MeasureTime frame
NMSS;NMS Quest;PDQ-39;Chinese Medicine Symptom Score;

Countries

China

Contacts

Public ContactLi Wentao

Affiliated Traditional Chinese Medicine Hospital of Shanghai University of Traditional Chinese Medicine

lwt1132@163.com+86 133 3188 2730

Outcome results

None listed

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