NCT03952676

Brief Summary

The purpose of this study was to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

May 15, 2019

Last Update Submit

May 15, 2019

Conditions

Plaque Psoriasis

Keywords

Plaque PsoriasisBlood stasis syndromeRandomized controlled trialMoving cupping

Outcome Measures

Primary Outcomes (1)

  • Psoriasis area and severity index (PASI)

    Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.

    Up to 56 days after treatment

Secondary Outcomes (6)

  • Body surface area (BSA)

    Up to 56 days after treatment

  • Physician Global Assessment (PGA)

    Up to 56 days after treatment

  • Dermatology Life quality index(DLQI)

    Up to 28 days after treatment

  • Patient-reported quality of life (PRQoL)

    Up to 28 days after treatment

  • Visual Analogue Score (VAS)

    Up to 56 days after treatment

  • +1 more secondary outcomes

Study Arms (2)

Moving cupping intervention

EXPERIMENTAL

Participants will received moving cupping therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.

Device: Moving cupping

Moving cupping placebo control

PLACEBO COMPARATOR

Participants will received moving cupping placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.

Device: Moving cupping placebo

Interventions

Moving cuppingDEVICE

1. We use a black opaque eye mask to shield the patient's eyes and choose different sizes of cup according to the location of the treatment (There are three sizes of cups) 2. (1) First apply Vaseline to the skin lesions area; (2) Then hold the 95% ethanol cotton ball with tweezers, and hold the cup with the facing down, after the cotton ball is ignited, immediately sway down in the cup and then exit, and quickly buckle the cup to the skin lesions area. (3) After using the cup to absorb the skin lesions area, hold the cup body in one hand and push and pull the cup along the certain route with a little strength, so that the skin purple color of the treatment area is suitable. (4) Apply even force when pushing the cup to prevent the cup from falling off due to air leakage. (5) Acting on the skin lesions area 30 times, change cup 5 times per push and pull, the interval is not more than 10 seconds.

Moving cupping intervention
Moving cupping placeboDEVICE

Using of special perforated cups, the manipulation method is the same as the intervention group.

Moving cupping placebo control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic criteria for plaque psoriasis;
  • Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
  • Aged between 18 and 65 years.
  • Consent to participate in the research study and sign the informed consent form

You may not qualify if:

  • Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
  • Plaque psoriasis patients with BSA\>10%;
  • Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
  • Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit e.g.: drugs for other studies, immuno-suppressive drugs, biologics;
  • Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
  • Active infectious disease which was hard to control;
  • History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times; Any of the main routine blood indexes (WBC, RBC, HB, PLT) is lower than the limit of normal; or other laboratory abnormalities and patients were judged not to be suitable for this study;
  • Family history of cancer-prone patients;
  • Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
  • Pregnant or lactating women;
  • Patients with a history of alcohol abuse and drug abuse;
  • Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Location

The Affiliated Hospital of Jiangxi University of TCM

Nanchang, Jiangxi, China

Location

Shaanxi Provincial Hospital of traditional Chinese Medicine

Xi'an, Shaanxi, China

Location

Shijiazhuang traditional Chinese medicine hospital

Shijiazhuang, Shijiazhuang, China

Location

Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang, China

Location

Related Publications (1)

  • Xing M, Yan X, Yang S, Li L, Gong L, Liu H, Xu R, Chen J, Ying L, Zhao Y, An Y, Liu Y, Huang G, Guo F, Yin Q, Wang R, Li B, Li X. Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial. Trials. 2020 Feb 26;21(1):229. doi: 10.1186/s13063-020-4155-0.

    PMID: 32102679DERIVED

Study Officials

  • Jia Zhou

    Shanghai Yueyang Integrated Medicine Hospital

    STUDY CHAIR

Central Study Contacts

Bin Li

CONTACT

0086-021-5598130118930568129@163.com

Xin Li

CONTACT

00861366195632613661956326@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 16, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations

CN(5)