CTRI/2024/03/063786已完成3 期
A Prospective, Randomized, Double-Blind, Parallel, placebo-controlled Clinicallnterventional Study to Evaluate the Safety and Efficacy of zenroot Ashwagandha 1.5% on Stress,Anxiety and Mood in Subjects with Stress.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Stressed male or female adults aged between 18 to 55 years (both limits inclusive).
- •2. BMI of 18.5 kg/m2
- •to 29.9 kg/m2
- •(both limits inclusive).
- •3. Subjects with mild to moderate stress as determined by a score =7 or =26 on the
- •4. Subjects who agree to maintain their usual dietary habits and level of exercise i.e.
- •maintain their usual lifestyle throughout the trial period.
- •5. Subjects willing to refrain from taking any medications or preparations for
- •addressing stress or anxiety or mood (herbal, dietary supplements, homeopathic
- •preparations, etc.) during the study.
- •6. Subjects willing to refrain from consuming alcohol 24 hours prior to the test days.
- •7. Subjects willing to refrain from consuming caffeine and caffeine-containing
- •products 12 hour prior to test days
- •8. Subjects willing to refrain from vigorous physical activity 12 hours prior to test
- •9. Subjects who agree to stay weight stable during the study period.
- •10. Subjects who agree to have a minimum 7–8-hour sleep before the visit days and
- •during the study period.
- •11. Female subjects of child bearing potential practicing an acceptable method of birth
- •control such as Intrauterine Device in place for at least 3 months prior to the start
- •of the study and remaining in place during the study period, contraceptive
- •transdermal, injection or implants, non-hormonal or hormonal, abstinence:
- •Subjects who shall be practicing abstinence shall agree to have a documented
- •second acceptable method of birth control should the subject become sexually
- •active during the course of her study participation for the duration of the study as
- •judged by the investigator(s)/study physician and agree to follow the same should
- •be used during treatment.
- •Postmenopausal for at least 1 year.
- •Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy
- •has been performed on the subject).
- •12. Subjects willing to provide written consent.
- •13. Subjects shall be willing and able to understand and comply with the requirements
- •of the study, consume the study IP as instructed, return for the required treatment
- •period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
- •2. Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal
- •condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency,
- •hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator
- •3. Subjects with a psychiatric diagnosis including anxiety or depression
- •4. Subjects with sleep disturbances and/or are taking sleep aid medication
- •5. Subjects having hypersensitivity or history of allergy to the study product
- •6. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally
- •acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications
- •7. Subjects with a history of drug and /or alcohol abuse at the time of enrolment
- •8. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
- •9. Subjects with positive Urine Pregnancy Test prior randomization
- •10. Subjects who have been treated with any investigational drug or investigational device within a
- •period of 3 months prior to study entry
- •11. Subjects with severe stress based on PSS score greater than 26
- •12. Subjects with uncontrolled hypertension -systolic blood pressure greater 160 mm Hg or diastolic blood
- •pressure greater 100 mm Hg at screening
- •13. Excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater than or equal to 3 cups of caffeinated
- •coffee/day) throughout the study period
研究者
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