An open clinical trial of Poly Herbal Siddha Drug Venpoosanai Lekiyam (Internal medicine) and Ulunthu Thylam (External medicine) in the treatment of Venneer Noi (Dhat Syndrome) with and without Psycho Education Therapy
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • DSSC scoring 81 to 12 - Mild
研究概览
简要总结
This study is a dissertation study for the partial fulfilment of MD Siddha PG study programme.
This is a open clinical trail will be conduct at Ayodidoss Pandithor Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047, TamilNadu, India under TamilNadu Dr. MGR Medical University.
I Got the IEC approval on 05.10.2015, Now I am Proceeding to the authentication of Trial drugs ingredients and also preparing the trial medicine.
I have plan to start the clinical trial on July 05th 2016 under the Supervision of my Course Supervisor and will be complete the Clinical trial on April 2017. then Dissertation writing work will start and on July will be Submit for. evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •â€¢ Weakness, anxiety, sleeplessness, mild depression and guilt which is attributed to semen loss. • Loss of semen through nocturnal emissions and masturbation frightens the individual as he believes it to be harmful to the body. • Report a white discharge in their urine which they feel is semen. • Mention that passing semen during defecation • Sexual dysfunction may or may not be present. • Willing to give specimen of blood and sperm for the investigations before and after treatment. • Willing to participate in Psycho.
- •education therapy session.
排除标准
- •â€¢Diabetes mellitus •Severe Cardiac Diseases •Severe Respiratory Diseases •Acute and chronic Renal Diseases •Needed for Surgical Treatment •Alcohol and Substance Abuse •Other severe Psychiatric Illness •Mentally Challenged •Physically Challenged •Severe Malignancy Diseases •Any other chronic Illness.
结局指标
主要结局
• DSSC scoring 81 to 12 - Mild
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
1. Comparison before and after intervention with DSSC
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
2. Categorization by the DSSC scoring
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
• DSSC scoring ≤ 40 - Good
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
• DSSC scoring 41 to 80 - Moderate
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
Outcome will be assecced by before and after intrvention throgh DSSC score.
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
Primary Outcome
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
• DSSC scoring ≥ 12 – Nil
时间窗: Time points is fourty eight (48) days | Primary Outcome | 1. Comparison before and after intervention with DSSC Score | 2. Categorisation by the DSSC scoring | • DSSC scoring ≤ 40 - Good | • DSSC scoring 41 to 80 - Moderate | • DSSC scoring 81 to 12 - Mild | • DSSC scoring ≥ 12 – Nil
次要结局
- Secondary Outcome(The effectiveness of Psycho-education by comparing before and after treatment)