Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: Placebos; Drug: Ganoderma

Study type: Interventional

Funder types: Other

Identifiers

NCT03594656

2017YFC1310202

Details and patient eligibility

About

Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients.

Enrollment: 288 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting the criteria for "Probable Parkinson's disease" according to 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease
• Aged 30-80 years
• Hoehn-Yahr Stage≤2
• UPDRS Part III subscores ranging from 10 to 30 points
• Disease duration of 5 years or less
• Untreated with antiparkinsonian drugs for at least two weeks preceding the trial
• Willing to sign the written informed consent

Exclusion criteria

• Atypical or secondary parkinsonism
• With psychiatric symptoms or a history of psychiatric diseases
• With cognitive impairment(MMSE score<24)
• Major liver or kidney dysfunction
• Participating in other clinical trials within 3 months preceding the current trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

288 participants in 2 patient groups, including a placebo group

Early-start Group

Experimental group

Description:

Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks

Treatment:

Drug: Ganoderma

Delayed-start Group

Placebo Comparator group

Description:

Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks

Treatment:

Drug: Placebos

Drug: Ganoderma