Therapeutic Efficacy and Safety of Karaskara Keram (Anubhuta Yoga) as external application over head in the Management of Chronic Insomnia: A Randomized, Controlled, Single-Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
研究概览
简要总结
Background: Chronic insomnia is a prevalent sleep disorder associated with impaired quality of life, psychological distress, and increased risk of chronic morbidity. Conventional pharmacological treatments often have limitations related to tolerance, dependency, and adverse effects, highlighting the need for safe and effective complementary interventions. Karaskara Keram, an Ayurvedic Anubhuta Yoga prepared using Strychnos nux-vomica processed according to classical purification and taila paka principles, is traditionally used as an external therapy for sleep disturbances.
Aim: To evaluate the therapeutic efficacy and safety of Karaskara Keram applied externally over the head in the management of chronic insomnia.
Methods: This is a randomized, controlled, single-blind, parallel-arm clinical trial conducted at a tertiary Ayurveda care center. A total of 62 patients aged 20–70 years, diagnosed with chronic insomnia as per DSM-5 criteria and having an Insomnia Severity Index (ISI) score >7, will be enrolled and randomized into two groups. The trial group will receive 5 ml of Karaskara Keram applied over the vertex of the head with gentle scalp massage for 15–20 minutes daily before head bath for four weeks. The control group will receive kerathaila in an identical manner. Primary outcomes include changes in ISI, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Regensburg Insomnia Scale (RIS). Secondary outcomes assess sleep diary parameters, psychological status using DASS-42, quality of life using SF-36, and safety through clinical monitoring and laboratory investigations. Statistical analysis will be performed using appropriate parametric or non-parametric tests with a significance level set at p < 0.05.
Expected Outcome:
The study aims to generate scientific evidence on the efficacy, safety, and tolerability of Karaskara Keram as a non-pharmacological, external Ayurvedic intervention for chronic insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of Insomnia Disorder in accordance with DSM-5 criteria for a minimum duration of three months Baseline Insomnia Severity Index (ISI) score less than 7, indicating at least subthreshold insomnia.
- •Willingness to comply with trial procedures and provide written informed consent.
排除标准
- •Psychiatric comorbidities including schizophrenia, major depressive disorder, psychosis, epilepsy, or anxiety disorders.
- •Substance use disorders including alcohol or drug dependency.
- •Other primary sleep disorders such as narcolepsy, circadian rhythm disorders, parasomnias, or sleep-disordered breathing.
- •Chronic systemic diseases such as asthma, malignancies, liver cirrhosis, uncontrolled hypertension, diabetes mellitus, and chronic kidney disease.
- •Recent use of hypnotic medications or psychotherapy within the past four weeks.
- •Those who are having dandruff, alopecia and such kinds of Shiroroga.
- •Pregnant and lactating women.
- •Those who are not willing to sign the informed consent.
研究者
Dr Govindan Namboodiri
Glocal University