An Open Label Comparative Clinical Study To Evaluate The Effect Of Vibhitaki Phala MajjaTerminalia Belerica Capsule and Aromatherapy With Vacha Acrus Calamus Linn Dhupa in Working Women VisAVis Primary Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment criteria:
研究概览
简要总结
This is Ramdomized open labelled parallel group study comparing the safety and efficacy of trial drug
Group A - Vibhitaki phala majja capsule (400mg) 1 HS/ afterfood with warm water.
Group B - Aroma-therapy with Vacha dhupa(5gm) once a day, 10min Before bed time.
Dosage of Group A wiil be 400mg capsule at bed time and for group B Vacha dhupa for 10mins at bed time for 28 days for 15 patients to each group and will be conducted in Shri Dharmashtala Manjunatheswara College of Ayurveda, hosptial and research Centre,kuthpady, Udupi, Karnataka, India. The Primary majors will be assessed through Athens insomnia scale, Insomnia severity index and Baseline values of Visual analogue scale.
The secondary outcome majors will be assessed based on the quality of life scale hence this study is an effort to prove the efficacy of Vibhitaki phala majja capsule and Aroma-therapy with Vacha dhupa in working women w.s.r primary insomnia.
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
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Working women fulfilling diagnostic criteria of Insomnia as per DSM-5 and ICD-
- •Patients are selected of age group between 20-40years.
- •Patients willing to sign informed consent.
排除标准
- •Patients suffering from any systemic illness, psychiatric illness or disorder and other metabolic disorders interfering with the treatment protocol.
- •Pregnant and lactating women.
- •Patient suffering from Substance abuse, Circadian rhythm disorder, Parasomnia.
结局指标
主要结局
Assessment criteria:
时间窗: observation will be made on 0th,14th and 28th day
Parameters will be scored by standard method and will be assessed before and after treatment on
时间窗: observation will be made on 0th,14th and 28th day
0 th , 14 th and 28 th day and will be analysed statistically.
时间窗: observation will be made on 0th,14th and 28th day
1) Athens insomnia scale
时间窗: observation will be made on 0th,14th and 28th day
2) Insomnia severity index
时间窗: observation will be made on 0th,14th and 28th day
3) Baseline values of Visual analogue scale (0-10) of Angamarda, Shirogourava, Jrumba,
时间窗: observation will be made on 0th,14th and 28th day
Jaadya, Glani, Bhrama, Apakthi, Tandra compared with values of Visual analogue scale (0-
时间窗: observation will be made on 0th,14th and 28th day
10) on 28 th day.
时间窗: observation will be made on 0th,14th and 28th day
4) WHO Quality of life scale-Brief
时间窗: observation will be made on 0th,14th and 28th day
Scored parameters will be analysed statistically after the treatment. All the subjective
时间窗: observation will be made on 0th,14th and 28th day
parameters and scales will be assessed using Wilcoxon signed rank test within the groups and
时间窗: observation will be made on 0th,14th and 28th day
Mann-Whitney U test in between the groups.
时间窗: observation will be made on 0th,14th and 28th day
次要结局
- quality of life(0th day and 28th day)
研究者
Dr Sughosh S Mujumdar
Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi