Effectiveness of selected Yogic techniques with sapthasaram kashaya to sapthasaram kashaya alone in pain & associated symptoms of primary dysmennorhoea for 3 months among working women aged 18-35 years -A Randomized Controlled Trial

Government Ayurveda Medical College Thiruvananthapuram1 个研究点分布在 1 个国家目标入组 212 人开始时间: 2023年10月3日最近更新: 2023年7月3日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 212
试验地点: 1
主要终点: 1.Intensity of pain

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Dysmenorrhoea is painful menstruation whichincapacitate her day to day activities.UdavarthaYoni vyapath mentioned in Ayurveda resembles primary dysmenorrhea.RandomizedControlled Trail will be done.106 working women withmoderate to severe primary dymenorrhoea each will be randomly allocated intostudy and control groups by allocation concealment.Group1 will be given selected Yogic techniques-from 5th day of eachmenstrual cycle namely Asanas ,Pranayama, Sadkarma, Meditation. Yoga will becontinued for 3 consecutive months. Each month 10 sachets of 48 g Sapthasaram kashaya churnawith 5 gm of hingu will be provided for both groups. Each month both groups hasto prepare 98ml Sapthasaram kashaya with 500 mg hingu as anupana and has totake kashaya 7 days prior tomenstruation and on 3 days of menstruation. Sapthasara kashaya with hingu willbe continued for 3 consecutive months.The pain and associated symptoms of Primary dysmenorrhoea in both groups will be assessedBT,AT,AF on 0th day,90th day,180th day. The change in Quality of life in bothgroups will be assessed BT,AT,AF on 0th day,90th day,180thday.TheQuality of Life Enjoyment and Satisfaction Questionnaire - Short Form(Q-LES-Q-SF) a 16 item self-administeredquestionnaire that captures life satisfaction over the past week will be usedto assess QOL.Statisticalanalysis will be done using appropriate statistical tests- Comparisonof quantitative variables between two group will be analyzed by Unpaired ttest or Mann Whitney U test according to the nature of the data. Comparisonof qualitative variables between two group will be analyzed by Chi squaretest. Dataanalysis will be performed using SPSS version 16. Analysis of variance (R M ANOVA) will be used to assess anydifferences in Qâ€LESâ€Qâ€SF scores

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, fixed
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 35.00 Year(s)（—）
性别: Female

入选标准

•1.working women with moderate to severe painful menstruation without any evident pelvic pathology 2.working women in age group 18-35 years 3.working women with at least 4 painful menstrual cycles during previous months 4.having informed consent from institution and from patient 5.subjects having regular menstrual cycles.

排除标准

•1.subjects who are not willing to do yoga 2.subjects with known cases of PID, DUB, any pelvic pathology 3.subjects with known cases of severe systemic illness and anatomical defects 4.subjects on oral contraceptive pillls 5.subjects having irregular menstrual cycle 6.subjects having malignancy.