跳至主要内容
临床试验/CTRI/2025/03/082765
CTRI/2025/03/082765尚未招募2 期

A Randomized Comparative Clinical Trial of Shiro Dhara And Shiro Abhyanga with Tila Taila In Chittodvega With Special Reference To Generalised Anxiety Disorder.

Vd Renuka Rajabhau Sulakhe1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Shiro Abhyanga more and equally effective than Shiro Dhara with Tila Taila in reducing symptoms of Chittodvega(Generalised Anxiety Disorder)

研究概览

简要总结

Tittle - A Randomized Comparative Clinical Trial of Shiro Dhara and Shiro Abhyanga with Tila Taila in Chittodvega With Special Reference To Generalised Anxiety Disorder.”

Background and purpose of study-

This study aims to compare the effects of Shirodhara and Shiro Abhyanga with Tila Taila on Chittodvega, focusing on Generalized Anxiety Disorder (GAD). The goal is to assess the effectiveness of these Ayurvedic treatments in reducing anxiety symptoms and improving mental well-being, with evidence from a randomized clinical trial.

Hypothesis -Shiro Abhyanga is more or equally effective than Shiro Dhara with Tila Taila in the management of Chittodvega (Generalised Anxiety Disorder).

Null hypothesis -Shiro Abhyanga with Tila Taila is less effective than Shiro Dhara with Tila Taila in the management of Chittodvega (Generalised Anxiety Disorder).

STUDY DESIGN This study employs a randomized comparative clinical trial design.

INCLUSION CRITERIA

  1. Patients who are diagnosed with Chittodvega (Generalised Anxiety Disorder) with DSM V [8] Diagnostic criteria.

  2. Patients who are not suffering any other psychiatric disorder.

  3. Patients in the age group 17-60 year.

  4. Patients who are not on any other medication for the same disease.

  5. Patients who are indicated for Shiro Dhara and Shiro Abhyanga.

  6. Informed consent of willingness of patient.

EXCLUSION CRITERIA

1.Patients on any other medication on Chittodvega.

2.Patients who are below age group 17 and above 60.

3.Patients who are contraindicated for Shiro Dhara and Shiro Abhyanga.

4.Patients who are suffering from any other psychiatric disorder.

sample size 60 (30 for each group)

patient coming to  opd and ipd of our hospital

SAMPLING TECHNIQUE

Simple random sampling (lottery).

1.Group A- (Shiro Abhyanga): 30 Participants receive Shiro Abhyanga therapy using Tila Taila.

2.Group B- (Shiro Dhara): 30 Participants receive Shiro Dhara therapy using Tila Taila.

DURATION OF TREATMENT -14 DAYS.

FOLLOW UP 14th day

Result- Result will be drawn as per assessment criteria and statistical analysis

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • 1 Patients who are diagnosed with Chittodvega (Generalised Anxiety Disorder) with DSM V Diagnostic criteria.
  • 2 Patients who are not suffering any other psychiatric disorder.
  • 3 Patients in the age group 17-60 year.
  • 4 Patients who are not on any other medication for the same disease.
  • 6 Informed consent of willingness of patient.

排除标准

  • 1.Patients on any other medication on Chittodvega.
  • 2.Patients who are below age group 17 and above
  • 3.Patients who are contraindicated for Shiro Dhara and Shiro Abhyanga.
  • 4.Patients who are not diagnosed with DSM V criteria 5.Patients who are suffering from any other psychiatric disorder.

结局指标

主要结局

Shiro Abhyanga more and equally effective than Shiro Dhara with Tila Taila in reducing symptoms of Chittodvega(Generalised Anxiety Disorder)

时间窗: 7 days intervention with follow up on 7th and 14 th day

次要结局

  • Shiro Abhyanga with Tila Taila is less effective than Shiro Dhara with Tila Taila in the management of Chittodvega (Generalised Anxiety Disorder)

研究者

发起方
Vd Renuka Rajabhau Sulakhe
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Renuka Rajabhau Sulakhe

MES Ayurved Mahavidyalaya

研究点 (1)

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