Effectiveness of Gut Microbiome as an add on to T.ESCITALOPRAM ( Anti Depressant ) in Depressive Disorder: A Randomised Double Blinded Prospective Treatment Evaluation Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease in the Hamilton depression rating score (HAM -D 21) is taken as response to the cap.GUTBRAX.
研究概览
简要总结
1.Patients diagnosed as Depressive disorder according to ICD 11[L2-6A7 ] will be recruited into the study.
Intake proforma having socio demographic profile will be filled .
2.HAM-D[21] will be administered to assess the severity.
3.Baseline investigations CBC,TFT,ESR will be done.
4.Patients will be grouped based on Simple random sampling procedure.
5.First group will be treated withT.ESCITALOPRAM 10mg/day and Rescue medication will be used wherever required.
6.Second group will be treated with T.ESCITALOPRAM 10mg/day plus C.GUT BRAX 2 capsules/day and Rescue medication
will be used wherever required.
7.After 2 weeks of initiation of treatment, all the patients will be subjected to clinical evaluation and adminstered with HAM-D [21] to assess the improvement and the dose of T.ECITALOPRAM will be adjusted as per the clinical requirement and continued with medication for 4 weeks .
8.After 6 weeks from the date of recruitment all the patients will be subjected to clinical evaluation and adminstered with HAM-D [21]to assess the improvement and as per the clinical requirement dose of T.ESCITALOPRAM will be adjusted and continued with medication for 4 weeks .
9.After 10 weeks from the date of recruitment ,all the patients will be subjected to clinical
evaluation and adminstered with HAM-D[21] to assess the improvement.
10.All the findings will be entered into the MS Excel (version :2019)sheet then will do statistical analysis using SPSS(VERSION:23)
11.Analysed data will be presented in the form of Tables, Pie diagram and Grouped or stacked bar diagram .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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.Patients who have been diagnosed as moderate or severe depressive disorder according to ICD 10 first episode or multiple episodes.
- •2.Subjects willing to give consent.
排除标准
- •Patients diagnosed with Mild Depressive Disorder.
- •Patients diagnosed with Bipolar Depression.
- •Patients with a Pre-existing mental illness other than Depressive disorder.
- •Patients who are diagnosed with Thyroid abnormalities.
- •Patients who were diagnosed with Gastrointestinal infections or with inflammatory bowel disease during 4 weeks before inclusion into the study.
- •Patients who have been on Steroids or Antibiotics during 4 weeks before inclusion into the study.
结局指标
主要结局
Decrease in the Hamilton depression rating score (HAM -D 21) is taken as response to the cap.GUTBRAX.
时间窗: Hamilton depression rating score assessment is done on day of recruitment into study then after 2 weeks ,6 weeks and 10 weeks.
次要结局
- Assess the tolerability of the C.GUTBRAX.(Assessing the tolerabilty after 2 weeks of initiation of treatment then after 6 weeks and 10 weeks.)
研究者
Dr K ASHOK REDDY
SVS Medical College Hospital