Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953885
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Affiliated hospital of jiangxi university of traditional Chinese medicine
Shijiazhuang Hospital of Traditional Chinese Medicine
Heilongjiang University of Chinese Medicine
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Psoriasis area and severity index (PASI) [ Time Frame: Up to 56 days after treatment ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Body surface area (BSA) [ Time Frame: Up to 56 days after treatment ]
    The percentage of body surface area (BSA) involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%)
  • Physician Global Assessment (PGA) [ Time Frame: Up to 56 days after treatment ]
    Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)].
  • Dermatology Life quality index(DLQI) [ Time Frame: Up to 28 days after treatment ]
    The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.
  • Patient-reported quality of life (PRQoL) [ Time Frame: Up to 28 days after treatment ]
    Patient-reported quality of life (PRQoL) is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.
  • Visual Analogue Score (VAS) [ Time Frame: Up to 56 days after treatment ]
    Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).
  • TCM syndrome score [ Time Frame: Up to 56 days after treatment ]
    The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome
Official Title  ICMJE Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
Brief Summary This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.
Detailed Description Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Other: Fire needle
    1. Participants wear eye masks and fully expose the lesions. After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation. After selecting an acupuncture needle with a specification of 0.4*40mm and ignites the alcohol lamp, the operator continuously moves the needle from the needle root to the needle tip to burn the red needle to disinfect the needle in the outer flame of the alcohol lamp.
    2. The operator ignites the alcohol lamp, and burns the needle tip and the needle body to the outer flame of the alcohol lamp until it is completely red (the length of the needle burning red is determined by the acupuncture depth), and then rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.
  • Other: Fire needle Placebo
    1. Participants wear eye masks and fully expose the lesions (no lesions on the head and face, external genitalia and skin folds). After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation, then selects an acupuncture needle with a specification of 0.4*40mm to prepare for operation.
    2. The operator rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.
Study Arms  ICMJE
  • Experimental: Fire needle group
    Participants in experimental group will receive Fire needle 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.
    Intervention: Other: Fire needle
  • Placebo Comparator: Fire needle placebo group
    Participants in experimental group will receive Fire needle 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.
    Intervention: Other: Fire needle Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Comply with the diagnostic criteria of Western medicine for plaque psoriasis and the diagnostic criteria for TCM syndromes;
  2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
  3. Age between 18 and 65 years old;
  4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

  1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
  2. Other active skin diseases may affect the condition assessment;
  3. Received research drugs, biological agents and immunosuppressive agents within 1 month;
  4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
  5. During severe, uncontrollable local or systemic acute or chronic infections;
  6. Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
  7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
  8. Such surgery will be required during major surgery or study during 8 weeks;
  9. Pregnant or lactating women;
  10. A person with a history of alcohol abuse, drug abuse or drug abuse;
  11. Have a history of serious mental illness or family history;
  12. Other reasons researchers believe that it is inappropriate to participate in this research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bin Li 0086-021-55981301 18930568129@163.com
Contact: Ting Dai 0086-021-65161782-3137 tingdai@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953885
Other Study ID Numbers  ICMJE 2018YFC1705303-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shanghai Yueyang Integrated Medicine Hospital
Study Sponsor  ICMJE Shanghai Yueyang Integrated Medicine Hospital
Collaborators  ICMJE
  • Shaanxi Provincial Hospital of Traditional Chinese Medicine
  • Affiliated hospital of jiangxi university of traditional Chinese medicine
  • Shijiazhuang Hospital of Traditional Chinese Medicine
  • Heilongjiang University of Chinese Medicine
Investigators  ICMJE
Study Chair: Jia Zhou Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
PRS Account Shanghai Yueyang Integrated Medicine Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP