Evaluation of the comparative efficacy of Sahadevi Ghan Vati versus Tablet Zolpidem in the management of Anidra ( Primary Insomnia)- A Randomized Controlled 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
- Enhance sedative effect of Sahadevi Ghan Vati in the management of Anidra (Primary
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 computerized generated table. Clinical Research format will be prepared and validated . Prior To study approval will be taken From IEC MGACHRC Salod (H) and CTRI registeration will be done . After selection each participants will be tested individually and selected to criteria . They are divided into two groups . The trial is Open labelled equivalence Clinical Controlled Trial. It will include a 30 days treatment period and 15th and 30th day will be Follow up period
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed Consent: Ability and willingness to provide written informed consent.
- •Patients of either sex, between the age group 18 and 65 years
- •Diagnosis: Primary insomnia as per DSM-IV-TR criteria
- •Insomnia Severity Index (ISI) Greater than 7
- •Sleep latency greater than 30 minutes
- •Total sleep time less than 6 hours per night 7.
排除标准
- •Anidra due to alcohol or drug abuse
- •Insomnia with major psychiatric illness like schizophrenia, depressive psychosis, epilepsy, bipolar disorder etc.
- •Patients with drug dependency were excluded.
- •Patients having acute illness like cardiovascular accidents, myocardial infarction and chronic obstructive pulmonary diseases.
- •Pregnant or lactating women.
- •Participation in another clinical trial within the past 3 months
- •Use of sedative-hypnotic medication within 1 week prior to the study.
- •Other sleep disorders (e.g., sleep apnea, narcolepsy, restless leg syndrome).
结局指标
主要结局
Enhance sedative effect of Sahadevi Ghan Vati in the management of Anidra (Primary
时间窗: In 4 weeks
Insomnia)
时间窗: In 4 weeks
次要结局
- improved sleep quality(30 days)
研究者
Dr Gauri Thakre
Room no 3Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha