Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection.
Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the time to recovery from the disease symptoms.
Study design and outcome measures:Study population of 182 generally healthy subjects with acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo treatment, with randomization stratified by site. The study supplement administration will be continued for 7 days, and patient global assessment (PGA) will be the main primary measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be taken at inclusion of patient and a number of blood tests at the end of treatment to look for any adverse effects of the medication.
Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the supplement and its correlation to the clinical and laboratory parameters.
연구 개요
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Beer Sheba, 이스라엘
- 모병
- Revivim and Mashabei Sadeh Clalit Clinics
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연락하다:
- Yael Peleg, MA
- 전화번호: 972-8-6479941
- 이메일: ypeleg@bgu.ac.il
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연락하다:
- Assi Cicurel
- 전화번호: 972-54-2401500
- 이메일: cicurels@gmail.com
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수석 연구원:
- Assi Cicurel, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Signed Informed Consent
- Age eligible (18 ≤ Age ≤ 90)
- Respiratory infection with or without fever-
Exclusion Criteria:
- Evidence of the bacterial infection
- Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms).
- Hospitalisation is planned
- Surgery within previous 2 months
- Pregnancy (women at childbirth age should have a urine beta-HCG test performed)
- Subject with known renal dysfunction (creatinine ≥ 2 mg/dL)
- Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ ULN
- Participation in the active follow-up phase of another clinical study of an investigational drug or device
- Known hypercalcemia -
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Food supplement
Half of the subjects participating in the trial (91) will recieve four tablets of the food supplement (Gardemont Goldrain Plus) three times a day for seven consecutive days from inclusion.
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Four tablets of 760 mg of GT+ administered three times a day for seven consecutive days and similar placebo tablets given to the control arm
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Global Assessment (PGA)
기간: Seven days
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Patient global assessment (PGA) will be a primary measurement, based on the self-reporting answer to the following question: "What is your overall feeling as compared to the first day of treatment: worse, same or better".
Time from the enrollment to the first 12 hours when the subject reports on a sustained improvement in symptoms (two consequent 12 hours periods) will be a primary outcome.
The study supplement administration will be continued for 7 days.
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Seven days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of safety composite
기간: 30 days
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Death, hospitalizations, serious adverse effects
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30 days
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공동 작업자 및 조사자
수사관
- 연구 책임자: Zvi Bentwich, MD, Ben-Gurion University of the Negev
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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