Juanbi Pill for Rheumatoid Arthritis

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).

Clinical Trial Description

Rheumatoid arthritis patients are suffering from painful and swelling of joints as well as joint destruction and functional disability with the duration of disease activity. Patients and physician try to find a way to alleviate the swell and tenderness of joints to avoid irreversible joints impairment, for evidence indicating that early aggressive treatment results in greater improvement than therapy initiated later in the disease course.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to achieve a clinical remission, or push the disease back to low disease activity. In traditional Chinese medicine (TCM), rheumatoid arthritis is a Bi syndrome and Juanbi decotion (notopterygium root, radix angelicae pubescentis, Gentiana macrophylla, Kadsura Pepper Stem, Mulberry Twig, Angelica sinensis, Ligusticum wallichii, frankincense, Radix Aucklandiae, shaved cinnamon barka and liquorice ) is a medicine specially for Bi syndrome and it has been used in Chinese for hundreds of years. Juanbi pill is the raw extration of Juanbi decotion for the sake of convenience of quality control and storage.

Although the long term usage of Juanbi decotion, there is no high quality evidence about the decotion on rheumatoid arthritis. Using a well-designed clinical trial, the investigators will survey the effectiveness of concurrent use of this decotion in relieving disease activity. Therefore, the present study is to examine effectiveness and safety of Juanbi Pill, a compound traditional Chinese herbal medicine on rheumatoid arthritis in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Juanbi pill as an intervention to lower the disease activity and protect the affected joints from deformity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02885597
Study type	Interventional
Source	Shanghai University of Traditional Chinese Medicine
Contact	Yongjun Wang, Doctor
Phone	86-189177763018
Email	yjwang8888@126.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	July 2018
Completion date	December 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.