Comparative Evaluation of the efficacy of standard market preparation (Tablet) and swayamguptadivati in the management Of Klaibya (Erectile Dysfunction): A randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in the levels of Sr Testosterone
研究概览
简要总结
The volunteers will be informed about the study protocol. willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACH RC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They will be divided into two groups as the trial is a parallel group, randomized, open clinical, standard controlled trial. It will include a 30 days treatment period and follow up on 0 and 30th day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients willing to participate in the study and give written informed consent.Patients with partial or complete erectile dysfunction reported with symptoms.Each mentioned a patient with IIEF identified sexual dysfunction.Patients having total testosterone level less than 249ng/mL.
排除标准
- •Current treatment with antihypertensive medication.
- •Subject who have significant heart disease.
- •History of neurological disorder.
- •Homosexual person.
- •History of penile trauma, injury, surgery.
- •Subjects with history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 month.
结局指标
主要结局
Improvement in the levels of Sr Testosterone
时间窗: 30 Days
次要结局
- Improvement in IIEF Questionnaire Scale(30 Days)
研究者
Dr Sourabh Deshmukh
Mahatma Gandhi Ayurved College Hospital and Research Centre ,Salod Hirapur Wardha