- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04471298
A Study of Qishenyiqi Dripping Pills in Healthy Participants
2021년 7월 13일 업데이트: Tasly Pharmaceutical Group Co., Ltd
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Evaluate the Safety and Tolerability of Continuous Oral Treatment With Qishenyiqi Dripping Pills in Healthy Participants
This study will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy participants, following oral administration with multiple escalating dose of it.
연구 개요
상태
완전한
정황
상세 설명
Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and pain relief.
This study is a randomized, double-blind, placebo-controlled, dose-escalation design study, including three cohorts and 36 healthy participants. Within each cohort, participant will receive Qishenyiqi dripping pills at the selected dose level by oral administration three times a day for 28 consecutive days.
연구 유형
중재적
등록 (실제)
36
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tianjin
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Tianjin, Tianjin, 중국
- The First Teaching Hospital of Tianjin University of TCM
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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)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Healthy volunteers, male or female, aged 18-50 years (including the boundary value);
- Participants weigh at least 50.0 kg in male and 45.0 kg in female with a body mass index of all subjects between 19 and 26kg/m2 (including the boundary value);
- Participants are willing to have no pregnancy program and take effective contraceptive measures voluntarily since signing informed consent form to 3 months after the last administration;
- Participants are willing to sign Independent Ethics Committee (IEC)-approved informed consent form and able to understand and comply with study procedures.
Exclusion Criteria:
- Participants with allergic constitution or have a history of allergy to drug or food;
- Participants with diseases or physiological conditions that may affect the study, including but not limited to diseases of the nervous, mental, respiratory, cardiovascular, digestive, blood and lymphatic, endocrine, musculoskeletal systems, liver and kidney dysfunction;
- Participants who have any clinically significant abnormalities in vital signs, physical examination, electrocardiogram, chest radiograph, abdominal ultrasound and laboratory examination;
- Participants who have positive test for hepatitis B virus surface antigen (except surface antibodies), hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
- Women who are in the state of pregnancy or lactation;
- Participants who have a history of drug abuse or a positive test result for drug abuse at screening;
- Participants who have smoked more than 5 cigarette per day or used a considerable amount of nicotine-containing products within the previous 3 months, and could not quit smoking during the experiment;
- Participants who have been drinking more than 14 units of alcohol per week within the previous 3 months (1 unit ≈285 mL beer with 3.5% alcohol or 25 mL spirits with 40% alcohol or 85 mL wines with 12% alcohol), or positive test for alcohol, or could not abstain from drinking during the trial;
- Participants who have taken any prescription drugs (including prescription, nonprescription, herbal medicine, dietary supplement such as vitamin product and calcium tablet) within 4 weeks before administration of investigational drugs;
- Participants who have difficulty in venous blood collection or history of fainting blood or needles;
- Participants who have participated in any drug clinical trial within 3 months and have taken the experimental drug or plan to participate in other clinical trials during the trial period;
- Participants who have donated or lost blood ≥200 mL within 3 months or received blood transfusion or used blood products, or have blood donation plan during the trial period;
- Judged by the investigator, participants have poor compliance or have other factors such as clinical, social or family that should not be included in the trial.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Active dosage group 1
Qishenyiqi dripping pills, 3.12g, oral, three times a day
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28 consecutive days
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활성 비교기: Active dosage group 2
Qishenyiqi dripping pills, 4.68g, oral, three times a day
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28 consecutive days
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활성 비교기: Active dosage group 3
Qishenyiqi dripping pills, 6.24g, oral, three times a day
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28 consecutive days
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위약 비교기: Control dosage group 1
Qishenyiqi dripping pills placebo, 3.12g, oral, three times a day
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28 consecutive days
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위약 비교기: Control dosage group 2
Qishenyiqi dripping pills placebo, 4.68g, oral, three times a day
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28 consecutive days
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위약 비교기: Control dosage group 3
Qishenyiqi dripping pills placebo, 6.24g, oral, three times a day
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28 consecutive days
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adverse events
기간: From screening (2 weeks in advance) till follow-up visit (up to 1week)
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Observe all the adverse events of all participants administrated orally with Qishenyiqi dripping pills.
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From screening (2 weeks in advance) till follow-up visit (up to 1week)
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Number of participants with abnormal vital signs index (body temperature)
기간: From screening (2 weeks in advance) till the end of trial period (Day 29)
|
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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From screening (2 weeks in advance) till the end of trial period (Day 29)
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Number of participants with abnormal vital signs index (pulse rate)
기간: From screening (2 weeks in advance) till the end of trial period (Day 29)
|
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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From screening (2 weeks in advance) till the end of trial period (Day 29)
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Number of participants with abnormal vital signs index (respiratory rate)
기간: From screening (2 weeks in advance) till the end of trial period (Day 29)
|
To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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From screening (2 weeks in advance) till the end of trial period (Day 29)
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Number of participants with abnormal vital signs index (blood pressure)
기간: From screening (2 weeks in advance) till the end of trial period (Day 29)
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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From screening (2 weeks in advance) till the end of trial period (Day 29)
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Physical examination
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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Number of participants with abnormal laboratory assessments (blood routine test)
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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Number of participants with abnormal laboratory assessments (blood biochemical test)
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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Number of participants with abnormal laboratory assessments (coagulation function test)
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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Number of participants with abnormal laboratory assessments (urinalysis routine test)
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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Number of participants with abnormal laboratory assessments (fecal routine test)
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)
기간: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
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screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2020년 9월 21일
기본 완료 (실제)
2021년 1월 11일
연구 완료 (실제)
2021년 1월 11일
연구 등록 날짜
최초 제출
2020년 7월 3일
QC 기준을 충족하는 최초 제출
2020년 7월 9일
처음 게시됨 (실제)
2020년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 7월 13일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TSL-TCM-QSYQDW-I
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. .
Qishenyiqi dripping pills, 6 bags에 대한 임상 시험
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Tasly Pharmaceutical Group Co., Ltd모병
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Tasly Pharmaceutical Group Co., Ltd모병박출률 감소를 동반한 만성 심부전중국