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A randomized, double-blind, parallel placebo-controlled study on the efficacy of gel candies in the treatment of Parkinson's disease

A randomized, double-blind, parallel placebo-controlled study on the efficacy of gel candies in the treatment of Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105415
Enrollment
Unknown
Registered
2025-07-03
Start date
2025-04-22
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Parkinson's disease

Interventions

Intervention group:The intervention group orally took 5 capsules (0.5g/ capsule) of gel candy or placebo each time, taken at least 1 hour before meals or at least 2 hours after meals, twice a day (a
control group:The control group orally took 5 capsules (0.5g/ capsule) of placebo each time, taken at least 1 hour before meals or at least 2 hours after meals, twice a day (a total of 5g/ day), for

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age: 40 to 75 years old, gender not limited (including 40 and 75 years old); 2. Patients diagnosed with Parkinson's disease according to the "Diagnostic Criteria for Parkinson's Disease in China (2016 Edition)"; 3. MMSE scale score >= 26 points; 4. The Hoehn and Yahr scale score is level 1 to 3; 5. Understand and abide by the trial process, participate voluntarily, and sign the informed consent form (the informed consent form shall be signed voluntarily by the individual or their legal representative).

Exclusion criteria

Exclusion criteria: 1. Clinical manifestations are atypical Parkinson's syndrome or there is a history of atypical Parkinson's syndrome; 2. Patients with other neurological complications, such as dementia, epilepsy, cerebral infarction, cerebral hemorrhage, brain trauma, craniocerebral tumors, and a history of craniocerebral surgery, etc. 3. Diagnose patients with anxiety, depression, mental illness, alcohol dependence, drug dependence, etc 4. Mini-Mental State Assessment (MMSE)<=24; 5. Pregnant women or those who are breastfeeding; 6. Those who are allergic to the test drug or the excipients of the research drug (mannitol, hydroxypropyl cellulose, cross-linked polyretinone, talcum powder, sodium bicarbonate, magnesium stearate, copolymer of methacrylate and ethyl acrylate, triethyl citrate, titanium dioxide).

Design outcomes

Primary

MeasureTime frame
Part III Scoring of the UPDRS Scale;

Secondary

MeasureTime frame
Hoehn and Yahr Scale;The frequency and extent of the occurrence of the "switching phenomenon";

Countries

China

Contacts

Public ContactLi Zhenshui

Beijing Tiantan Hospital, Capital Medical University

lzsbb@163.com+86 139 1052 3919

Outcome results

None listed

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