跳至主要内容
临床试验/CTRI/2025/03/083018
CTRI/2025/03/083018尚未招募3 期

Efficacy of Mansyadi Ghanvati and Ratricharya with or without Bhramari Kumbhaka in the Management of Mild and Short-term Insomnia in Geriatric Population - An Open Labelled Randomized Comparative Clinical Trial

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
•Improvement in quality of sleep of the patients with mild and short Insomnia in geriatric population according to ICSD criteria.

研究概览

简要总结

**Introduction:**Nidra is considered one of the most important aspects of a relaxed state of mind and overall health. Acharya Charaka highlights the role of Kala and Vata in regulating Nidra and Anidra. Vata, with its Chala Guna, disrupts Mana’s rest, contributing to Anidra, especially in Vata-dominant period of aging and causes insomnia in geriatric population. In Ayurvedic classics, various treatment modalities for Anidra like Lifestyle modifications, Dietary changes, Medications, Panchakarma therapies, etc. Medications like Mansyadi Ghanvati have Nidrajanaka, Balya, and Vatahara properties. Lifestyle modifications such as Ratricharya, Dinacharya are emphasized in the classics, with Ratricharya being particularly important for promoting health. Pranayama has recently gained more popularity because of its multifold health benefits. It is believed that one can control the power of mind through regulating the breath. Among the different types of Kumbhaka, Bhramari Kumbhaka is stated the best to give a blissful condition of mind. **Rationale For Selection of Topic:**Insomnia complaints are more prevalent among older adults. The type of insomnia symptom changes as a function of age, with difficulties initiating sleep being more common among young adults and problems maintaining sleep occurring more frequently among middle-age and older individuals. Overall, the prevalence of insomnia symptoms ranges from 30% to 48% in the elderly, whereas the prevalence of insomnia symptom disorder ranges from 12% to 20%. Sleep maintenance symptoms are more prevalent among individuals with insomnia (50%-70%), followed by difficulty in initiating sleep (35%-60%) and non-restorative sleep (20%-25%). **Aim and Objectives:**To evaluate the efficacy of Mansyadi Ghanvati and Ratricharya with Bhramari Kumbhaka in the management of mild and short-term insomnia in geriatric population.**Materials and Methods:**30 patients of mild and short-term insomnia in geriatric population will be enrolled in two groups. In Group A(Trial Group ) will be taken Mansyadi Ghanvati and Ratrichrya with Bhramari Kumbhaka 5 cycles in the first 15 days, 7 cycles for 2nd 15 days, 11 cycles for 3rd 15 days and 15 cycles for last 15 days, while in Group B( Comparative Group ) will be taken Mansyadi Ghanvati and Ratricharya. **Results and Discussion:**Data generated during the above study will be present in a Systemic manner as shall be analyzed statically. Where the important points of the review of literature, Conceptual study, Analytical study will be discussed. **Follow up:**Patients will be advised to visit the hospital every 15 days during the treatment for 8 weeks and after the completion of therapy for the duration of after 15 days for one month as a follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1 Age group.
  • 60-80 years 2 Patients of mild and short-term insomnia. 3 Patients willing to accept the participation in clinical trial. 4 Individuals with controlled primary systemic diseases.

排除标准

  • 1 Age below 60 years and above 80 years.
  • 2 Patients suffering from chronic insomnia disorder.
  • 3 Patients suffering from severe or moderate insomnia.
  • 4 Secondary Insomnia.
  • 5 Fatal Familial Insomnia.
  • 6 Patients with alcohol or drug dependency.
  • 7 Advanced chronic illnesses such as bronchial asthma, diabetes, cancer, liver cirrhosis, chronic renal failure.
  • 8 Acute illnesses such as cerebrovascular accidents, myocardial infarction, COPD, epilepsy.
  • 9 uncontrolled systemic diseases like Diabetes (Random Blood sugar not more than 200 mg/dl), hypertension (not more than 180/100 mm Hg).
  • 10 Patients with major psychiatric illnesses like schizophrenia, depressive psychosis, bipolar disorders, obsessive compulsive disorder, personality disorders, mood disorders, panic disorders, post-traumatic stress disorders.

结局指标

主要结局

•Improvement in quality of sleep of the patients with mild and short Insomnia in geriatric population according to ICSD criteria.

时间窗: 8 weeks

次要结局

  • •Improvement in associated complains of Anidra.(•Improvement in the level of stress.)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vd kapuriya dixita

Institute of Teaching and Research in Ayurveda

研究点 (1)

Loading locations...

相似试验