跳至主要内容
临床试验/CTRI/2024/07/070878
CTRI/2024/07/070878尚未招募3 期

The efficacy of Saraswatham choornam as an add-on to Cognitive behavioural therapy in improving the symptoms of Generalized anxiety disorder- A randomized clinical trial

Vaidyaratnam Ayurveda college1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月29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
40
试验地点
1
主要终点
• Changes in the anxiety scoring of Hamilton Anxiety Rating Scale.

研究概览

简要总结

Generalized anxiety disorder is characterized by persistent uncontrolled worry for more than 6 months about everyday things which could be multifocal and presented with many psychological and physical symptoms. Cognitive behavioural therapy and medications are the two main treatments. In this study, 40 subjects aged 20 to 50 years diagnosed with ICD 10 Criteria are divided into two groups of 20 participants each. Both groups are provided with 5 sessions of Cognitive behavioural therapy. One group will be given Ayurvedic medicine Saraswatham choornam 4gm with 8 gm of ghrutha and 4gm of madhu BD after food. The allocation will be concealed using the snooze technique. Outcome will be collected using a direct personal interview method and will be assessed by Hamilton anxiety rating scale and Manasabhava scale. Statistically tested using parametric and non-parametric tests.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed cases of Generalized Anxiety Disorder based on ICD10 Criteria 2.20- 50 age group irrespective of gender, caste, religion and economic status.
  • 3.Diagnosis should be confirmed by a specialist in Manasikaroga Vijnana.

排除标准

  • • Patients with psychiatric disorder & other systemic and metabolic disorders • Drug abuse and withdrawal patient.
  • • Pregnant women, Lactating women.
  • • Participants having completed any other trial within 6 months.
  • • Patients taking allopathic medications for GAD.

结局指标

主要结局

• Changes in the anxiety scoring of Hamilton Anxiety Rating Scale.

时间窗: At 0th, 28th and 35th day

• Changes in manasabhava scale score

时间窗: At 0th, 28th and 35th day

次要结局

  • Changes in manasabhava scale score(On 1st, 28th and 35 th day)

研究者

发起方
Vaidyaratnam Ayurveda college
申办方类型
Other [Aided college]
责任方
Principal Investigator
主要研究者

Dr Shifana P M

Vaidyaratnam Ayurveda College Thaikkattussery, Ollur

研究点 (1)

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