CTRI/2026/02/104058尚未招募不适用
A Principal Investigator blind, Single Center, Prospective, Randomized Clinical Study to Evaluate the efficacy and safety of Kashmir Lavender (Lavandula angustifolia) oil in participants with impaired sleep patterns and self-reported sleep issues.
CSIR-Indian Institute of Chemical Technology, Hyderabad & Integrative Medicine, Jammu1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2026年2月28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
- 111
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygiene
研究概览
简要总结
The objective of this study is to evaluate efficacy and safety of Kashmir Lavender Lavandula angustifolia oil in participants with impaired sleep patterns and self-reported sleep issues.
- Primary Objective: To evaluate the efficacy of Kashmir Lavender Lavandula angustifolia oil in participants with impaired sleep patterns and self-reported sleep issues.
- Secondary Objective: To assess the safety of Kashmir Lavender Lavandula angustifolia oil in participants with impaired sleep patterns and self-reported sleep issues.
The overall study will include 111 participants, and the additional sleep tracking will provide deeper insights into how Kashmir Lavender oil may impact sleep patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Male and female participants aged 18 to 65 years.
- •Participant has self reported sleep issues such as difficulty falling asleep, frequent awakenings during the night, or daytime sleepiness.
- •Participant has total PSQI score greater than
- •Weight not less than 50 kg for male and 45 kg for female and BMI between 18.50 and 30.00 kg per square meter inclusive.
- •Participants with screening vital signs within normal limits, or with values outside the normal range that are deemed clinically insignificant by the physician or principal investigator.
- •Participant able to read, understand and sign informed consent form.
- •Participant willing not to use spray or any type of fragrance before sleeping at night in the room.
- •Ready to follow study protocol until study completion.
排除标准
- •Participants who have night shift work or use prescription sleep medications.
- •Participants with PHQ 9 score greater than or equal to 10 and GAD 7 score greater than or equal to 10 during the screening visit.
- •Hypersensitivity to active ingredients of investigational product or any related chemical substances or excipients in the formulation.
- •Nasal allergy, nasal pathology such as history of bleeding or active bleeding, and nasal infections.
- •Refusal to undergo the procedure.
- •Known history or presence of the following: a.
- •Cardiovascular, pulmonary, metabolic, hepatic, renal, hematological, gastrointestinal, ocular, endocrine including diabetes, immunologic, dermatologic, venereal, neurological, musculoskeletal or psychiatric disorders.
- •Asthma, urticaria or other allergic reactions after taking any medication.
- •Alcohol dependence, alcohol abuse or drug or chemical abuse such as marijuana THC, cocaine, morphine, benzodiazepines, barbiturates and amphetamine within the past one year.
- •Respiratory system dysfunction such as rhinorrhea or nasal polyps, or respiratory tract infection.
- •Participants with difficult airway or obstructive sleep apnea syndrome.
- •Pregnant women and breastfeeding mothers.
- •Females of childbearing potential refusing to use contraceptive methods.
- •Any other condition that prevents adequate understanding, cooperation and compliance with study procedures or any condition that could pose a risk to participant safety as per the investigator’s judgment.
结局指标
主要结局
To evaluate the efficacy of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygiene
时间窗: Visit 1 to Visit 2 (Day 1 to Day 14 + 2 days)
次要结局
- To assess the safety of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygiene(Spray the lavender oil twice, approximately 200 microliters in total, each night before sleep for 14 days)
研究者
Dr Mangesh Shende
Akshar Global Clinical Research Private Limited
研究点 (1)
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