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Trial record 7 of 1709 for:    psoriasis

Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study

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ClinicalTrials.gov Identifier: NCT03942185
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
Zhejiang Provincial Hospital of TCM
Shanghai Dermatology Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Changhai Hospital
Shanghai 10th People's Hospital
Beijing Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Chinese Medicine Hospital Affiliated to Southwest Medical University
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Affiliated hospital of jiangxi university of traditional Chinese medicine
The Second Affiliated Hospital of Jiangxi University of TCM
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
The First Affiliated Hospital of Guiyang College of TCM
The Second People's Hospital Affiliated to Fujian University of TCM
Affiliated Hospital of Gansu University of traditional Chinese Medicine
Shanxi Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

Brief Summary:
The purpose of this study is to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy Phase 2

Detailed Description:

Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.

Chinese Medicine (CM) has unique advantages in treatment of psoriasis. On the basis of CM principle——"Blood Differentiation and Treatment" in psoriasis and the combination of clinical experience, Chinese famous professor Wanzhang Qin proposed the "New Blood Syndrome Theory" in psoriasis——the psoriasis based in blood, with blood heat first, and blood stasis throughout the whole process of psoriasis. This study will form a systematic report on the diagnosis and treatment of psoriasis with the New Blood Syndrome Theory; theoretically verified by prospective cohort studies, a theoretical system of the New Blood Syndrome Theory for psoriasis will be constructed.

Objectives of this study are to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psoriasis with Blood heat syndrome group
Participants in Psoriasis with Blood heat syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Clearing heat and Cooling blood, such as Cool blood detoxification Decoction I,Cool blood and activating blood prescription compound, Cool blood detoxification Decoction II, Cool blood activating blood Decoction, Tufu drink, Xiaoyin Decoction and etc., two times per day for 8 weeks.
Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Experimental: Psoriasis with Blood stasis syndrome group
Participants in Psoriasis with Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Promoting blood circulation and Removing blood stasis, such as Huoxue Sanyu Xiaoyin Decoction, Cool blood detoxification Decoction III and etc., two times per day for 8 weeks.
Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Experimental: Psoriasis with Non-Blood heat or Blood stasis syndrome group
Participants in Psoriasis with Non-Blood heat or Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of syndrome differentiation therapy two times per day for 8 weeks.
Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy
Oral Chinese Herbal Medicine according with syndrome differentiation therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

No Intervention: Healthy control group
No Intervention.



Primary Outcome Measures :
  1. Psoriasis Area and Severity Index [ Time Frame: Up to 56 days after treatment ]
    Psoriasis Area and Severity Index 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.


Secondary Outcome Measures :
  1. Body surface area (BSA) [ Time Frame: Up to 56 days after treatment ]
    The percentage of 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 (%).

  2. 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)].

  3. Dermatology Life quality index(DLQI) [ Time Frame: Up to 56 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.

  4. Patient-reported quality of life (PRQoL) [ Time Frame: Up to 56 days after treatment ]
    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.

  5. 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).

  6. CM symptom score [ Time Frame: Up to 56 days after treatment ]
    The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria of psoriatic:

  1. In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
  2. 18 to 65 years old, male or female patient;
  3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
  4. Informed consent must be obtained.

Exclusion Criteria of psoriatic:

  1. Patients with a history of serious mental illness or family history;
  2. Other reasons that the investigator considered inappropriate to participate in the study.

Inclusion Criteria of health volunteers:

  1. Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
  2. 18 to 65 years old, male or female patient;
  3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
  4. Informed consent must be obtained.

Exclusion Criteria of health volunteers:

  1. Other active skin diseases which may affect the condition assessment are present;
  2. Those with severe, uncontrollable local or systemic acute or chronic infections;
  3. Patients with a history of serious mental illness or family history;
  4. Other reasons that the investigator considered inappropriate to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942185


Contacts
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Contact: Bin Li 008618930568129 18930568129@163.com
Contact: Xin Li 008613661956326 13661956326@163.com

  Show 20 Study Locations
Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
Zhejiang Provincial Hospital of TCM
Shanghai Dermatology Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Changhai Hospital
Shanghai 10th People's Hospital
Beijing Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Chinese Medicine Hospital Affiliated to Southwest Medical University
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Affiliated hospital of jiangxi university of traditional Chinese medicine
The Second Affiliated Hospital of Jiangxi University of TCM
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
The First Affiliated Hospital of Guiyang College of TCM
The Second People's Hospital Affiliated to Fujian University of TCM
Affiliated Hospital of Gansu University of traditional Chinese Medicine
Shanxi Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Jia Zhou Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

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Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT03942185     History of Changes
Other Study ID Numbers: 2018YFC1705301
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
Psoriasis Vulgaris
Chinese Medicine
Real World Study
Clearing heat and Cooling blood
Promoting blood circulation and Removing blood stasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases