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NCT Number: NCT00656253

Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease

This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences, Beijing, Beijing Municipality, China

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About this study

This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Herbal Medicinal Mixture Bid or matched placebo for 12 months plus 1 month wash-out period.

Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.

The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS).

The hypothesis of this study was that Herbal Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease according to the UK Brain Bank criteria
  • Hoehn & Yahr stadium Ⅰ～Ⅲ
  • Age over 50 years
  • Taking only levodopa and/or dopamine agonists when recruiting
  • Consistent with the liver kidney deficiency type by Traditional Chinese Medicine (TCM) standard
  • Patients voluntarily take part in this study and signed the informed consent

Exclusion criteria

  • Modified Hoehn-Yahr scale are higher than 4
  • Had other serious illness such as liver/kidney failure, serious infection etc
  • Allergic to the study drug
  • Had been participated in other clinical trials during the last 3 months prior to study inclusion.
  • Taking Coenzyme Q10, MAO-B inhibitors, or vitamin E, all of which might improve the symptom or slowdown the progression of PD.
  • Taking herbal medicine that can nourish the liver and kidney by TCM standard.
  • Had serious mental disorder and could not describe his/her symptom.

Treatment and study plan

Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)

Drug

12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine

Placebo

Drug

12 months period of placebo plus 1 month period without placebo

Primary outcomes

  1. Levodopa equivalent dose(LED) per day

    Time frame: 13 months

    daily levodopa dose taken by PD patients to control their symptoms.

Secondary outcomes

  1. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 13 months

  2. Hoehn & Yahr scale

    Time frame: 13 months

  3. Schwab & England score

    Time frame: 13 months

  4. The liver kidney deficiency scale score by Traditional Chinese Medicine standard

    Time frame: 13 months

  5. Parkinson disease sleep scale (PDSS)

    Time frame: 13 months

  6. Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)

    Time frame: 13 months

  7. Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, ect.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • State Administration of Traditional Chinese Medicine of the People's Republic of China

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 11, 2008
Registry last updated
Mar 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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