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Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome.

2021년 8월 2일 업데이트: The First Affiliated Hospital of Zhejiang Chinese Medical University
Psoriasis is a non-contagious erythematous scaly skin disease characterized by epidermal proliferation and inflammation. The etiology is related to heredity, infection, allergies, metabolic disorders and autoimmunity. The incidence of psoriasis in the survey was about 1.2‰ in 1984 in China, and 2.6% in the United States. In recent years, the incidence of psoriasis has been on the increase trend, mostly in the young to middle age adults, and it can last a lifetime. The characteristic of the disease is that it usually spreads all over the body, or gradually aggravates, or is fixed and difficult to subside,or the disease course is long, lingering and difficult to heal, and it brings great harm to the patient's body and mind. At present, there is no effective treatment for psoriasis. Although western medicine has good short-term curative effects, prolonged use is not advocated because of adverse side effects and poor long-term effects. Besides, it is easy to relapse and aggravate after stopping the medicine. Psoriasis belongs to the category of "baibi" in Chinese medicine. Doctors of the past dynasties mostly treated it from blood heat, blood stasis, and blood deficiency syndrome. Researcher Zhu Renkang believes that "blood with heat" is the main cause of psoriasis and famous TCM dermatologists such as Zhang Zhili, Gu Bohua, Xu Yihou and others all regard "blood-heat syndrome" as the basic pathogenesis of psoriasis. We used Qingre Liangxue Recipe Granules to observe the treatment of 31 patients with blood-heat type psoriasis vulgaris, and found that the PASI index of the patients after treatment was significantly lower than before treatment (P <0.01), and the serum VEGF level was significantly decreased (P < 0.01), the correlation analysis between the two showed a significant correlation. This study aims to further evaluate the efficacy and safety of Qing-Re-Liang-Xue Decoction in comparison with commonly used glucocorticoids and calcipotriol ointment in patients with blood-heat type psoriasis vulgaris.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a multi-center, randomized, open-label, controlled pilot study of Traditional Chinese medicine (Qing-Re-Liang-Xue Decoction) as a complementary therapy to treat psoriasis vulgaris of blood-heat syndrome during a 10-week period. We estimate to enroll 200 subjects (treatment group(N=100); controlled group(N=100)).

연구 유형

중재적

등록 (예상)

200

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310006
        • 모병
        • First Affiliated Hospital of Zhejiang Chinese Medical University
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Yi Cao, Doc.
        • 부수사관:
          • Xiaohong Yang, Doc.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 18-65 years;
  • Had a diagnosis of psoriasis vulgaris for ≥6 months;
  • TCM syndrome evaluation belongs to blood-heat type patients: it is more common in the advanced stage of psoriasis. Symptoms: skin lesions develop faster, skin lesions are bright red, blood loss is obvious, scales are dry and thick, itching is severe; upset, and thirsty, dry stool; red-purple tongue, yellow fur, string or slippery or rapid pulse;
  • Patients without serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system or mental illnesses;
  • Those who are willing to cooperate and can persist in the treatment without interruption;
  • During the treatment period, those who have not taken or used other psoriasis drugs externally.

Exclusion Criteria:

  • Patients with serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system or mental illnesses;
  • History of immunosuppressant medication in the past three months;
  • Those who use other drugs during treatment or stop treatment on their own and have incomplete observation data;
  • Pregnancy or risk of pregnancy, and/or lactation;
  • Aged ≤18 or ≥65 years old;
  • Patients with other types of psoriasis, such as articular, pustular, and erythroderma.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Qing-Re-Liang-Xue Decoction.
One dose of granules is mixed, poured into 500ml of boiling water, and taken twice in the morning and afternoon. Women stop taking Chinese medicine during the first 3 days of menstruation. Triamcinolone Acetonide Acetate and Urea Cream,10g/tube and Calcipotriol Ointment,10g/tube are used alternately. The period of treatment will be 10 weeks.
의약품: Qing-Re-Liang-Xue Decoction.
One dose of granules is mixed, poured into 500ml of boiling water, and taken twice in the morning and afternoon. Women stop taking Chinese medicine during the first 3 days of menstruation.The period of treatment will be 10 weeks.
활성 비교기: control group
Topical steroids. Triamcinolone Acetonide Acetate and Urea Cream,10g/tube and Calcipotriol Ointment,10g/tube are used alternately. The period of treatment will be 10 weeks.
의약품: Triamcinolone Acetonide Acetate and Urea Cream.
10g/tube and CalcipotriolOintment,10g/tube are used alternately.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index (PASI) over the 10 weeks treatment period.
기간: 10 weeks
Psoriasis Area Severity Index (PASI) is usually used to measure the clinical activity diseases of psoriasis.
10 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in skin lesions are assessed by dermoscope.
기간: 10 weeks.
Image data of skin lesions, capillaries in the nail bed, capillaries near the wing of the nose, etc will be analyzed by the Image-Pro Plus software(Version 6.0，Media Cybernetics) to figure out the inner diameter of the blood vessel wall thickness ratio, Wall cavity cross-sectional area ratio and density.
10 weeks.
Evaluation of curative effect of Traditional Chinese medicine is assessed by patient reported outcome(PRO) and clinician reported outcomes(CRO).
기간: 10 weeks.
Healed: TCM syndromes and skin lesions disappeared, only pigmentation spots or depigmentation spots remained, and no new skin rashes. The TCM syndrome score is reduced by more than 90%; markedly effective: TCM syndromes and skin lesions have basically disappeared or only a few intractable small pieces remain, and the skin lesions are still slightly infiltrated. TCM syndrome scores are reduced by 60-89%; effective: TCM syndromes are significantly reduced, and skin lesions have subsided by more than 30%. TCM syndrome scores are reduced by 30-56%; ineffective: after 3 courses of treatment, the skin lesions still have no progress or the skin lesions have subsided by less than 30%. The reduction of TCM syndrome points is less than 30%.
10 weeks.
Compliance evaluation is assessed by Counting Days of Treatment.
기간: 10 weeks.
Compliance=The number of days the subject has received treatment/The number of days the subject should receive treatment*100%
10 weeks.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The First Affiliated Hospital of Zhejiang Chinese Medical University

협력자

Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine
Pujiang Hospital of Traditional Chinese Medicine
Yongkang Hospital of Traditional Chinese Medicine
Ningbo Hospital of Traditional Chinese Medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2021년 9월 1일

기본 완료 (예상)

2023년 7월 1일

연구 완료 (예상)

2024년 7월 1일

연구 등록 날짜

최초 제출

2021년 7월 14일

QC 기준을 충족하는 최초 제출

2021년 8월 2일

처음 게시됨 (실제)

2021년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 8월 2일

마지막으로 확인됨

2021년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2021-KLJ-001-02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심상성 건선에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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