Effect of Turmeric Spice Herbal Tea on Overall Immunity in Healthy Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Turmeric Spice Herbal Tea in improving overall immunity compared to normal tea
研究概览
简要总结
Eligible participants will undergo a screening visit to confirm inclusion/exclusion criteria and obtain baseline data, including demographics, medical history, and concomitant medications.
Following the baseline assessment, eligible participants will be randomized to receive either Turmeric Spice Herbal Tea or the Normal tea (Assam Black Tea, Grade - Orthodox leaves). Participants will be instructed to consume one cup (150 mL) of the assigned tea twice daily for 8 weeks and SDC will be handed over for documentation of self-reporting study endpoints.
There will be telephonic follow-up at Day 7 and Day 28. Participants will attend follow-up visit on completion of 8 weeks of drinking tea at the site for assessment of their immune status based on ISQ scores, infection frequency and duration, adverse events. Data will be collected regarding the incidence, duration, and severity of self-reported infectious illnesses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adults, both males and females, aged 18 to 65 years, both inclusive, at the time of screening.
- •Willing and able to provide written informed consent before any study related procedures.
- •This ensures that participants understand the study purpose, procedures, risks, and benefits and that their participation is voluntary.
- •Participants must be daily tea taker, Participants willing and able to comply with all study procedures, including daily consumption of the assigned tea Turmeric Spice Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study, Participants willing to attend scheduled study visits, and completing all required questionnaires.
- •Access to a telephone and the ability to be contacted by study personnel Agreement to maintain a stable diet throughout the study period Day 0 to Completion of 8 weeks of drinking tea and not undertake any major dietary changes Agreement to refrain from starting any new herbal supplements or making significant dietary changes defined as a substantial alteration in macronutrient intake or the introduction of restrictive diets during the study period.
- •Agreement to discontinue the use of any other immune modulating interventions for at least 2 weeks before enrolment and throughout the study duration.
- •Participants should not be enrolled in any other trials.
- •or planned surgery during the study period.
排除标准
- •Use of immunosuppressant medications methotrexate, azathioprine, cyclosporine or systemic corticosteroids prednisone within 3 months before enrollment.
- •Inhaled or topical corticosteroids are permitted.
- •Pregnant or breastfeeding women Participation in other clinical trials Participation in another interventional clinical trial within 30 days before enrollment.
- •Observational studies are permitted.
- •Regular use more than 3 times per week of immunomodulatory supplements, such as Echinacea, Elderberry, and High dose vitamin C more than 1000 mg daily, Vitamin D more than 4000 IU daily, and Zinc more than 50 mg daily.
- •Known bleeding disorders hemophilia, von Willebrand disease or regular use of anticoagulant medications warfarin, heparin, direct oral anticoagulants.
- •Subjects with uncontrolled diabetes Subjects who received vaccination for Influenza within the last 3 months Subjects judged ineligible by the investigator Subjects with a heart condition, malignant tumor, myocardial infarction, with a pacemaker or implantable cardioverter defibrillator ICD Subjects who had undergone surgery in the last 2 weeks.
结局指标
主要结局
To evaluate the efficacy of Turmeric Spice Herbal Tea in improving overall immunity compared to normal tea
时间窗: Baseline and 8 weeks
次要结局
- To assess the rate of infections and the duration of infection in subjects consuming Turmeric Spice Herbal Tea compared to normal tea(To assess the safety and tolerability of Turmeric Spice Herbal Tea compared to normal tea)
研究者
Sushavan Sinha
Luxmi Tea Co Private Limited