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临床试验/CTRI/2024/07/070191
CTRI/2024/07/070191尚未招募4 期

A Clinical and Comparative Study to Evaluate the Effect of Mahakalyanaka Ghrita and Panchagavya Ghrita in the Management of Chittodvega and its Medical Astrology Correlates

Sir Sunderlal Hospital Department of Kayachikitsa Faculty of Ayurveda1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Relief in sign and symptoms of the disease

研究概览

简要总结

150 clinically diagnosed patients of Chittodvega (Generalised Anxiety Disorder) will be registered and divided randomly into three groups with 50 patients in each group and following interventions will be done:

Group I (Control Group): Escitalopram 10mg

Group II: Mahakalyanaka Ghrita 24 grams

Group III: Panchagavya Ghrita 24 grams

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling the diagnostic criteria of DSM- V for Generalized Anxiety Disorder and willing to sign the informed consent.
  • Excessive anxiety and worry (apprehensive expectation), occurring more days than not for at least 6 months, about a number of events or activities (such as work or school performance).
  • The individual finds it difficult to control the worry.
  • The anxiety and worry are associated with three (or more) of the following six symptoms (with at least some symptoms having been present for more days than not for the past 6 months):
  • Restlessness or feeling keyed up or on edge.
  • Being easily fatigued.
  • Difficulty concentrating or mind going blank.
  • Irritability.
  • Muscle tension.
  • Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep).
  • The anxiety, worry, or physical symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
  • The disturbance is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition (e.g., hyperthyroidism).
  • The disturbance is not better explained by another mental disorder.

排除标准

  • Patients suffering from other Anxiety Disorders like- Separation Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorders.
  • Patients suffering from Substance or Medication Induced Anxiety.
  • Patients suffering from other psychiatric disorders like Depression, Bipolar Disorder.
  • Pregnant women.

结局指标

主要结局

Relief in sign and symptoms of the disease

时间窗: 60 days study with follow up of every 30 days

The main sign and symptoms in the study are as

时间窗: 60 days study with follow up of every 30 days

follows

时间窗: 60 days study with follow up of every 30 days

1. Excessive Worry

时间窗: 60 days study with follow up of every 30 days

2. Restlessness

时间窗: 60 days study with follow up of every 30 days

3. Easily Fatigued

时间窗: 60 days study with follow up of every 30 days

4. Difficulty in Concentration

时间窗: 60 days study with follow up of every 30 days

5. Irritability

时间窗: 60 days study with follow up of every 30 days

6. Muscle Tension

时间窗: 60 days study with follow up of every 30 days

7. Sleep Disturbance

时间窗: 60 days study with follow up of every 30 days

8. Depressed Mood

时间窗: 60 days study with follow up of every 30 days

9. Diminished Interest/ Pleasure

时间窗: 60 days study with follow up of every 30 days

10. Significant Weight Loss

时间窗: 60 days study with follow up of every 30 days

11.Insomnia/Hypersomnia

时间窗: 60 days study with follow up of every 30 days

12. Psychomotor Agitation/Retardation

时间窗: 60 days study with follow up of every 30 days

13. Fatigue

时间窗: 60 days study with follow up of every 30 days

14. Worthlessness/Guilt

时间窗: 60 days study with follow up of every 30 days

15. Diminished Concentration

时间窗: 60 days study with follow up of every 30 days

16. Recurrent Suicidal Ideation

时间窗: 60 days study with follow up of every 30 days

Astrological appearance of Graha, Mahadasha, Antardasha in Lagna Chart in Horoscope of patients with Chittodvega will be studied.

时间窗: 60 days study with follow up of every 30 days

次要结局

  • Assessment of scoring of following scales(1.Symptom Rating Scale)

研究者

发起方
Sir Sunderlal Hospital Department of Kayachikitsa Faculty of Ayurveda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Singh Divya

Banaras Hindu University

研究点 (1)

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