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临床试验/CTRI/2025/10/095966
CTRI/2025/10/095966尚未招募1 期

Clinical evaluation of Siddharthakadi Agad Ghrita Nasya in Smartphone addiction induced insomnia Nidranasha

Rishikul Campus, Haridwar, Uttarakhand Ayurved University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月22日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
SUBJECTIVE PARAMETERS

研究概览

简要总结

This study aims to clinically evaluate the efficacy of Siddharthakadi Agad Ghrita Nasya in patients suffering from insomnia induced by smartphone addiction, a growing behavioral health concern particularly among young adults. The trial is a single-arm, open-label clinical study and will enroll 40 participants who will be selected from OPD No. 2 of Rishikul Campus, Haridwar, based on specific inclusion and exclusion criteria. The treatment duration will be 45 days. Assessments will be carried out using both subjective and objective parameters. The intervention consists of Pratimarsha Nasya (nasal administration) with Siddharthakadi Agad Ghrita, given twice daily for the entire treatment period. This study is conducted to introduce a cost-effective, holistic management approach for smartphone addiction-related insomnia, with the potential to reduce reliance on sedatives and minimize associated adverse effects.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 1.Participants with insomnia scoring from 15 or above as per the insomnia severity index (ISI) caused due to smartphone addiction.
  • 2.Participants of either sex between the age group of 18 to 60 yrs.
  • 3.Participants fit for Nasya Karma.

排除标准

  • 1.Participants suffering from insomnia caused by factors other than smartphone addiction like diabetes, hypertension, asthma, migraine etc.
  • 2.Participants suffering from any other major psychiatric disorders like Schizophrenia etc.
  • 3.Pregnant & lactating women.

结局指标

主要结局

SUBJECTIVE PARAMETERS

时间窗: Follow up at an interval of 15 days.

1. Angamarda

时间窗: Follow up at an interval of 15 days.

2. Shirogaurav

时间窗: Follow up at an interval of 15 days.

3. Jrumbha

时间窗: Follow up at an interval of 15 days.

4. Jadya

时间窗: Follow up at an interval of 15 days.

5. Glani

时间窗: Follow up at an interval of 15 days.

6. Bhrama

时间窗: Follow up at an interval of 15 days.

7. Apakti

时间窗: Follow up at an interval of 15 days.

8. Tandra

时间窗: Follow up at an interval of 15 days.

次要结局

  • OBJECTIVE PARAMETERS(1. Sleep Induction)

研究者

发起方
Rishikul Campus, Haridwar, Uttarakhand Ayurved University
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Bhawana Mittal

Rishikul Campus, Haridwar, Uttrakhand Ayurved University

研究点 (1)

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