ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Gastrointestinal Tolerability
研究概览
简要总结
A comparison of an enteric coated and micro-coated formulation of ERr 731®
详细描述
Current clinical and commercialization experiences have been with enteric-coated formulations of ERr 731®. With the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of ERr 731® in new markets. It is proposed that a double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blinded as to order formulations are received in a standard cross-over design with washout phase
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
- •Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.
排除标准
- •A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
- •History of Breast or Uterine cancers.
- •Known infection with HIV, Tuberculosis or Hepatitis B or C.
- •Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
- •Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
- •Botanical Formulations - including phytoestrogens and progesterone-mimetic botanicals (Rhapontic Rhubarb, Soy Phytoestrogens, Hops (8-prenyl naringin) Red Clover, Kudzu, Chaste Tree Berry, Licorice, Resveratrol, Black Cohosh, Dong Quai, etc.)
- •Use of Narcotics during the last 30 days
- •Use of Anticoagulants during last 30 days
- •Use of Corticosteroids during the last 30 days
- •Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.
- •Consumption of more than 3 alcoholic beverages per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
- •Pregnancy
- •Breast Feeding
研究组 & 干预措施
Enteric/Micro Order
Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 1 will receive enteric coated ERr 731® during treatment phase 1 and micro-coated ERr 731®during treatment phase 2
干预措施: ERr 731 - Micro-coated (Dietary Supplement)
Enteric/Micro Order
Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 1 will receive enteric coated ERr 731® during treatment phase 1 and micro-coated ERr 731®during treatment phase 2
干预措施: ERr 731 - Enteric coated (Dietary Supplement)
Micro/Enteric Order
Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 2 will receive micro-coated ERr 731® during treatment phase 1 and enteric coated ERr 731®during treatment phase 2
干预措施: ERr 731 - Micro-coated (Dietary Supplement)
Micro/Enteric Order
Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 2 will receive micro-coated ERr 731® during treatment phase 1 and enteric coated ERr 731®during treatment phase 2
干预措施: ERr 731 - Enteric coated (Dietary Supplement)
结局指标
主要结局
Gastrointestinal Tolerability
时间窗: 14 days
Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire
次要结局
- General Tolerability(14 Days)