Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    100
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 27 January 2021

Summary

A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.

Details
Condition L-DOPA-Induced Dyskinesia, L-DOPA-Induced Dyskinesia, L-DOPA-Induced Dyskinesia, L-DOPA-Induced Dyskinesia
Treatment Tianqi Pingchan Granule Combined With Amantadine, Placebo Combined With Amantadine
Clinical Study IdentifierNCT04173832
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

PD patients between the ages of 30-85
Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score 2 points
The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour
The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment
Levodopa is administered at least three times a day

Exclusion Criteria

PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia
pregnant and lactating women
Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment
Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points
Psychiatric symptoms associated with anti-Parkinson's disease drugs
accompanied by a history of mental illness
impaired liver and kidney function
accompanied by severe other systemic diseases
Amantadine treatment has been received within the first 30 days of enrollment
History of medication with apomorphine or dopamine receptor antagonists
Previously taking amantadine, unable to tolerate
Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions
Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention
has received PD-related brain surgery
Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days
Patients who are unable to follow up with follow-up
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note