Parkinson's DiseasePhase 2/3NCT00656253
Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
A Phase 2/3 study testing Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) in people with Parkinson's Disease, run by Fudan University at 10 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 10 sitesChina
- Study dates
- Aug 2008to Feb 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, 100053
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Department of Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Shanghai Chinese Medical Hospital
Shanghai, Shanghai Municipality, 200071
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200233
Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Department of Neurology, The second people's hospital of Wenzhou
Wenzhou, Zhejiang, 325000
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.
Read the detailed description
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.
- Conditions
- Parkinson's Disease
- Being tested
- Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.), Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
12 months period of placebo plus 1 month period without placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levodopa equivalent dose(LED) per day
daily levodopa dose taken by PD patients to control their symptoms.
Measured: 13 months
Secondary outcomes (7)
Unified Parkinson's Disease Rating Scale (UPDRS)
Measured: 13 months
Hoehn & Yahr scale
Measured: 13 months
Schwab & England score
Measured: 13 months
The liver kidney deficiency scale score by Traditional Chinese Medicine standard
Measured: 13 months
Parkinson disease sleep scale (PDSS)
Measured: 13 months
Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)
Measured: 13 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- State Administration of Traditional Chinese Medicine of the People's Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656253
- Sponsor's protocol ID
- 2006BAI04A11
- Status last verified
- Sep 2009
- First submitted
- 7 Apr 2008
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
- ClinicalTrials.gov ID
- NCT00656253
- Acronym / sponsor ID
- 2006BAI04A11
- Conditions
- Parkinson's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- State Administration of Traditional Chinese Medicine of the People's Republic of China
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine | Drug | A |
| Placebo12 months period of placebo plus 1 month period without placebo | Drug | B |
Primary outcome
Levodopa equivalent dose(LED) per day
Time frame: 13 months
daily levodopa dose taken by PD patients to control their symptoms.
7 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 13 months
Hoehn & Yahr scale
Time frame: 13 months
Schwab & England score
Time frame: 13 months
The liver kidney deficiency scale score by Traditional Chinese Medicine standard
Time frame: 13 months
Parkinson disease sleep scale (PDSS)
Time frame: 13 months
Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)
Time frame: 13 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) in people with Parkinson's Disease, run by Fudan University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levodopa equivalent dose(LED) per day (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2011.