CTRI/2025/12/099333尚未招募不适用
A Randomized, Double Blind, Placebo Control study to assess the efficacy and safety of JOFP-001capsule versus placebo for the management of stress and anxiety in healthy adult subjects.
Jeeva Organic Private Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年11月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of JOFP-001 capsules in the management of stress and anxiety in healthy adult subjects. The main purpose of the trial is to determine whether JOFP-001 reduces perceived stress levels and improves anxiety scores compared to placebo. The study hypothesis is that JOFP-001 will show a significant reduction in stress and anxiety measures and will be well tolerated in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 65 years.
- •Individuals with mild to moderate stress and/or anxiety, as defined by: A Perceived Stress Scale (PSS) score greater than or equal to 14 and smaller than or equal to
- •A DASS-21 anxiety score between 08 and 14 with self-reported fatigue, insomnia, loss of appetite, and concentration.
- •Willing and able to provide written informed consent and comply with all study procedures.
- •Female, participants must be non-pregnant, non-lactating, and either postmenopausal or using an acceptable form of contraception (such as birth control pills, IUDs, or condoms) during the study.
- •Participants must have a stable lifestyle (such as no major changes in diet, exercise routine, or work schedule during the study period).
- •Participants must demonstrate normal vital signs and baseline laboratory values (such as liver function tests, kidney function tests, and electrolyte levels) as assessed during the screening process.
- •Participants must agree to avoid using other adaptogenic herbs, anti-anxiety medications, or supplements that could interfere with the study’s outcomes.
排除标准
- •Diagnosis of major depressive disorder, bipolar disorder, schizophrenia, or any other psychiatric condition requiring pharmacological treatment.
- •Use of anxiolytics, antidepressants, antipsychotics, or herbal supplementsfor stress/anxiety (e.g., ashwagandha, valerian root, L-theanine) within the past 4 weeks.
- •Current or recent history (within 6 months) of alcohol or substance abuse (e.g., cannabis, opioids, stimulants).
- •Known or suspected neurological, cardiovascular, renal, hepatic, or endocrine disorders that may interfere with the study or safety of the participant.
- •Pregnant or lactating women, or those planning pregnancy during the study.
- •Known hypersensitivity or allergy to any component of JOFP-001 capsule.
- •Uncontrolled hypertension, diabetes, or other chronic diseases that may affect study outcomes or participant safety.
- •Any condition (e.g., cognitive impairment, language barrier) that, in the investigator’s judgment, may affect the participant’s ability to provide informed consent or comply with study procedures.
- •Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day for men or 1 drink/day for women)
- •Participants participated in any investigational study medication within thirty (30) days prior to screening.
研究者
Dr Janani Sankar
Chennai Meenakshi Multispeciality Hospital
研究点 (1)
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