A Pharmaco-clinical Study Of Shwetasarshapa (Brassica campestris (Linn.)) Oil Nasya To Access Anxiolytic Effects As An Add On Therapy In The Management Of Anxiety Neurosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Reductions in symptoms HAMA Scale of Anxiety
研究概览
简要总结
The Study includes two groups Trial Group and ComparisonGroup.
Trial group:
The patients Shall be given Nasya of trialdrug Oil and Chlordiazepoxide (Cap. Librium 10mg) for 45 days.The Dose of Nasyaoil shall be in the form of marshyanasya 3ml to 5 ml in each nostril as per body constituents (Prakruti) for 7days and from 8th day onwards patients shall be given 1ml of pratimarshya nasya till 45th dayand Cap. Librium orally 10mg twice a day for total duration of 45 days.
Comparison Group (Group-II) :
The patients Shall be given Chlordiazepoxide(Cap.Librium 10mg) twice a day for duration of 45 days.
Route of administration: Nasal route fortrial drug. And Oral route for Cap.Librium for Comparison Group.
Outcome: The Trial drugs shall behelpful for reducing the signs and symptoms of the patient of Anxiety Neurosis.
Primary outcome will be the clinicalparameters observed during study using scale used of HAM-A.
Duration of Study: Total Duration ofStudy will be 45 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Pre-diagnosed case of Anxiety neurosis No discrimination of sex, race, caste and religion Onset between 8 weeks and 2years Subjects with known standard care of treatment Subjects with history of Diabetes mellitus type 2 and mild Hypertension.
排除标准
- •Diagnosed cases of Schizophrenia Subjects showing repeated Panic attack Subjects diagnosed as Medication-induced anxiety disorder, panic disorders, Post traumatic Stress Disorder Subjects having Specific phobia, Agoraphobia or any other chronic systemic disease as Irritable Bowel Syndrome Severe Kidney Disease Pregnant and Lactating women.
结局指标
主要结局
Reductions in symptoms HAMA Scale of Anxiety
时间窗: 0th day, 8th day, 15th days amd 45thday
次要结局
- reduction in symptoms of anxiety(after 45 days)