A prospective open label study to evaluate the safety, efficacy of KAL-HS-05 in the Management of Insomnia (Nidranasha)
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •% Improvement in sleep quality assessed by Sleep Quality scale[Time: Day 0 to Day 28]]
研究概览
简要总结
Nidranasha can be broadlydefined as the loss of sleep or the derangement in the quality and quantity ofsleep. Nidranasha or Anidra can also be called as the condition of difficultyin initiating or maintaining sleep. It is the condition also exhibited as wakingup early without complete sleep and with the feeling of tiredness andexhaustion. A sound sleep is mainly associated with mental wellness, stress andanxiety may also lead to gradually nidranasha (Insomnia). Acharya Sushruthaalso mentions Rajas as the Manasika Dosha leading to Nidranasha (Insomnia)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing to give informed consent.
- •2.Healthy Indian male/ female volunteer aged between 18-65 years.
- •3.Must be able to adhere to the study visit schedule and other protocol requirements.
- •4.Willing to complete the questionnaires for the total duration of treatment.
- •5.Patients suffering from insomnia/loss of sleep from last 1 month.
- •6.Willing to avoid usage of any NSAIDs, Sleep inducing medication, etc.
- •during the study duration.
- •7.Agree not to use any medication (prescription and over the counter), during the course of this study.
排除标准
- •1.Patients on Psychiatry medicine.
- •Patients on hypnotic medicine or any other drugs known to cause drowsiness.
- •3.Pregnant or Breast feeding.
- •4.Inability to provide voluntary consent.
- •5.Patients with pre-existing severe systemic disease like uncontrolled diabetes, hypertension, and Cardiac illness etc necessitating long term medication.
- •6.Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
- •7.Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •8.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 9.Use of any anti-psychotic drugs for one week prior to Baseline.
- •10.Subjects who abuse drugs or alcohol drug screening not required.
- •11.Use of any investigational medication within 4 weeks prior to start of study drug.
- •12.Greater than moderate alcohol use.
结局指标
主要结局
•% Improvement in sleep quality assessed by Sleep Quality scale[Time: Day 0 to Day 28]]
时间窗: Day 0 and Day 28
•% Betterment in the anxiety and stress level assessed by Hamilton’s Anxiety assessment scale. [Time: Day 0 to Day 28]
时间窗: Day 0 and Day 28
次要结局
- Safety & vital signs