Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial
Abstract Background Acute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limit...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-05-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06338-1 |
| _version_ | 1818201865277407232 |
|---|---|
| author | Ya-xi Shang Xia Dong Zhi-min Xie Xiao-peng Li Xin-chang Wang Ji-yong Huang Shu-feng Wei Yuan Liu Jian-ping Liu |
| author_facet | Ya-xi Shang Xia Dong Zhi-min Xie Xiao-peng Li Xin-chang Wang Ji-yong Huang Shu-feng Wei Yuan Liu Jian-ping Liu |
| author_sort | Ya-xi Shang |
| collection | DOAJ |
| description | Abstract Background Acute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limited by adverse events. There has been a traditional use of alternative therapies for AGA. Tibetan medicine Qingpeng ointment is one of the on-market herbal products used for symptom relief of AGA. Previous clinical studies indicated that Qingpeng ointment can relieve pain, swelling, redness, and dysfunction of joints in patients with AGA. However, there is no rigorous randomized trial to demonstrate its benefit for AGA. In order to evaluate the efficacy and safety of Qingpeng ointment for AGA, we designed a randomized controlled trial. Methods This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Two hundred and six adults with acute flare of gout, and visual analogue scale (VAS) score of joint pain ≥ 3 points will be recruited. Participants will be randomly assigned to herbal treatment or placebo group at a ratio of 1:1. Qingpeng ointment, or equal placebo ointment, will be applied topically at involved joints twice a day for consecutive 7 days. Patients in both groups would be allowed giving diclofenac sodium sustained-release tablets as rescue therapy when VAS score of joint pain ≥ 7 points during the treatment. The primary outcomes will be joint pain measured by VAS score, and joint swelling measured using width and thickness of affected joints and VAS score. Other outcome measures will be joint mobility, joint redness, C-reactive protein, serum uric acid, and the use of rescue medicine as well as adverse effect. Discussion To the best of our knowledge, this study is the first multi-center, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy of Tibetan medicine Qingpeng ointment for AGA. The findings of this study would provide evidence for its use to relieve symptoms of AGA. Trial registration ISRCTN ISRCTN34355813 . Registered on 25 January 2021 |
| first_indexed | 2024-12-12T03:00:20Z |
| format | Article |
| id | doaj.art-9ca9b137bdea4319a50e4080f557a8e0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T03:00:20Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9ca9b137bdea4319a50e4080f557a8e02022-12-22T00:40:38ZengBMCTrials1745-62152022-05-0123111010.1186/s13063-022-06338-1Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trialYa-xi Shang0Xia Dong1Zhi-min Xie2Xiao-peng Li3Xin-chang Wang4Ji-yong Huang5Shu-feng Wei6Yuan Liu7Jian-ping Liu8Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese MedicineFangshan Hospital, Beijing University of Chinese MedicineThe Second Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Second Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Second Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Second Affiliated Hospital of Zhejiang Chinese Medical UniversityFangshan Hospital, Beijing University of Chinese MedicineLiuzhou People’s HospitalCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese MedicineAbstract Background Acute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limited by adverse events. There has been a traditional use of alternative therapies for AGA. Tibetan medicine Qingpeng ointment is one of the on-market herbal products used for symptom relief of AGA. Previous clinical studies indicated that Qingpeng ointment can relieve pain, swelling, redness, and dysfunction of joints in patients with AGA. However, there is no rigorous randomized trial to demonstrate its benefit for AGA. In order to evaluate the efficacy and safety of Qingpeng ointment for AGA, we designed a randomized controlled trial. Methods This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Two hundred and six adults with acute flare of gout, and visual analogue scale (VAS) score of joint pain ≥ 3 points will be recruited. Participants will be randomly assigned to herbal treatment or placebo group at a ratio of 1:1. Qingpeng ointment, or equal placebo ointment, will be applied topically at involved joints twice a day for consecutive 7 days. Patients in both groups would be allowed giving diclofenac sodium sustained-release tablets as rescue therapy when VAS score of joint pain ≥ 7 points during the treatment. The primary outcomes will be joint pain measured by VAS score, and joint swelling measured using width and thickness of affected joints and VAS score. Other outcome measures will be joint mobility, joint redness, C-reactive protein, serum uric acid, and the use of rescue medicine as well as adverse effect. Discussion To the best of our knowledge, this study is the first multi-center, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy of Tibetan medicine Qingpeng ointment for AGA. The findings of this study would provide evidence for its use to relieve symptoms of AGA. Trial registration ISRCTN ISRCTN34355813 . Registered on 25 January 2021https://doi.org/10.1186/s13063-022-06338-1GoutAcute gouty arthritisJoint painQingpeng ointmentTibetan medicineRandomized controlled trial |
| spellingShingle | Ya-xi Shang Xia Dong Zhi-min Xie Xiao-peng Li Xin-chang Wang Ji-yong Huang Shu-feng Wei Yuan Liu Jian-ping Liu Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial Trials Gout Acute gouty arthritis Joint pain Qingpeng ointment Tibetan medicine Randomized controlled trial |
| title | Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial |
| title_full | Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial |
| title_fullStr | Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial |
| title_short | Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial |
| title_sort | efficacy and safety of tibetan medicine qingpeng ointment for acute gouty arthritis protocol for a multi center randomized double blind placebo controlled trial |
| topic | Gout Acute gouty arthritis Joint pain Qingpeng ointment Tibetan medicine Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-022-06338-1 |
| work_keys_str_mv | AT yaxishang efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT xiadong efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT zhiminxie efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT xiaopengli efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT xinchangwang efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT jiyonghuang efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT shufengwei efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT yuanliu efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial AT jianpingliu efficacyandsafetyoftibetanmedicineqingpengointmentforacutegoutyarthritisprotocolforamulticenterrandomizeddoubleblindplacebocontrolledtrial |