Efficacy of Ashwagandha-Turmeric Herbal Tea for Stress Relief 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
- 64
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Ashwagandha-Turmeric Herbal Tea in reducing perceived stress levels in healthy adults compared to normal tea
研究概览
简要总结
Eligible participants will provide informed consent, undergo a medical history review, and a physical examination. Baseline PSS, DASS, PSQI, and WHO-5 scores will be collected, along with a blood sample for assessment of baseline cortisol levels.
Participants meeting all inclusion criteria and no exclusion criteria will be randomized to either the Ashwagandha-Turmeric Herbal Tea group or the control group.
Following the baseline assessment, eligible participants will be randomized to receive either Ashwagandha-Turmeric Herbal Tea or the Normal tea (Assam Black Tea, Grade - Orthodox leaves). Participants will be instructed to for preparation of tea and 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 for the assessment of compliance, adverse events, and interim efficacy measures. After completion of 8 weeks, PSS, DASS, PSQI, and WHO-5 scores will be collected, along with a blood sample for cortisol levels and a final assessment of adverse events.
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
- •Male and Female adults aged 18 to 65 years both inclusive Generally healthy individuals, as determined by medical history and physical examination Self-reported stress levels, indicated by a score of 14 or more on the Perceived Stress Scale PSS Participants should have a score less than 15 on the World Health Organization five WHO 5 well being index 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, willing and able to comply with all study procedures, including daily consumption of the assigned tea Ashwagandha Turmeric Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study, attending scheduled study visits, and completing all required questionnaires and subject diaries.
- •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 and not undertake any major dietary changes Participants should be free of psychiatric conditions other than stress, as determined by medical history and the investigator.
- •Agreement to discontinue the use of any other herbal supplements or stress-reducing interventions aromatherapy, meditation 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
- •Known allergy or sensitivity to Ashwagandha, turmeric, or other ingredients in the herbal tea Current use of antidepressant, anti anxiety, or sleep altering medications Use of anticoagulant or antiplatelet medications Use of immunosuppressant medications Use of thyroid hormone medication, unless the condition is stable for at least 6 months Under diagnosis of any major psychiatric disorder History of significant gastrointestinal disease Pregnant or breastfeeding women Uncontrolled hypertension or unstable cardiovascular disease Uncontrolled diabetic patients Hyperthyroidism or uncontrolled hypothyroidism Participation in another clinical trial within the past 30 days.
- •Subjects with a score of 15 or higher on the World Health Organization five WHO 5 well being index Any other significant medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with the interpretation of the study results.
- •Participants were currently taking any herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo biloba, Brahmi, or related herbs Participants suffering from any chronic physical, hormonal, or psychiatric illness Participants with abnormal laboratory or ECG findings Participants having any substance dependence.
结局指标
主要结局
To evaluate the efficacy of Ashwagandha-Turmeric Herbal Tea in reducing perceived stress levels in healthy adults compared to normal tea
时间窗: Baseline and 8 weeks
次要结局
- To assess the impact of Ashwagandha-Turmeric Herbal Tea on anxiety levels compared to normal tea(To evaluate the effect of Ashwagandha-Turmeric Herbal Tea on sleep quality compared to normal tea)
- Exploratory Endpoint(To evaluate the effect of Ashwagandha Turmeric Herbal Tea on cortisol levels compared to normal tea)
研究者
Sushavan Sinha
Luxmi Tea Co Private Limited