An assessment of efficacy of Shatavari kalpa along with Sattvavajaya chikitsa in the management of Post Partum Depression: A randomised, open-labeled, comparative clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effect of shatavari kalpa in the management of post partum depression
研究概览
简要总结
Total 60 women within 4 weeks of giving birth upto 6 months’ post-partum in the age group pf 20-35yrs will be screened according to inclusion and exclusion criteria of the study and included in the study after taking written informed consent. They will be explained the whole work that is to be done provided the information of the patient’s to be confidential. Diagnosis of patients will be using EDINBURGH’S POSTNATAL DIAGNOSTIC AND SCREENING SCALE. All aspects of the treatment will be explained to the participating patient with written Informed consent. Inclusion criteria satisfied will be included, exclusion criteria satisfied will be excluded. Patient selection by purposive sampling method and will be divided in two groups ‘A’ and ‘B’.
30 patients enrolled in Group A will receive Shatavari kalpa 2 tsp (10 gms) once a day orally bhojanuttar with ushnodak (lukewarm water) for 4 weeks. 30 patients enrolled in Group B will receive Sattvavajay Chikitsain the form of Pranayam and meditation daily for 25 mins for 4 weeks with aashvasan chikitsa on every follow up and Shatavari kalpa 2tsp(10 gms) once a day orally bhojanuttar with ushnodak (lukewarm water) for 4 weeks.
Follow up will be taken with assessment of the patient on 0 day,1st week, 2nd week, 3rd week, 4th week. The data generated through clinical study will be subjected to unbiased statistical analysis to derive valid conclusions.
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 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •onset from 4 weeks to 6 months of postpartum irrespective of gravida.
排除标准
- •patients already diagnosed with neuropyschological disorders patients having systemic illness or postpartum haemorrhage.
结局指标
主要结局
To assess the effect of shatavari kalpa in the management of post partum depression
时间窗: Day 0, 1st week, 2nd week, 3rd week, 4th week
To assess the effect of sattvavajaya chikitsa in the management of postpartum depression
时间窗: Day 0, 1st week, 2nd week, 3rd week, 4th week
次要结局
- To compare the effect of shatavari kalpa with sattvavajaya chikitsa in the management of post partum depression
研究者
Dr Bhavika Dube
D. Y. Patil deemed to be university school of Ayurveda, Nerul, Navi Mumbai
