An open label double arm randomised controlled clinical study to compare the efficacy of jeeraka churna and integrated yoga therapy in udavartini yonivyapad, primary dysmenorrhea.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.VAS(Visual analogue scale)
研究概览
简要总结
Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pathology, it often leads to discomfort, reduced quality of life. Conventional treatments, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives,It can have adverse effects.Therefore, there is a pressing need for alternative therapies that are both effective and have a favorable safety profile.
The traditional system of medicine in India, offers various remedies for dysmenorrhea, one of which is Jeeraka Churna (Cumin seed powder). It is known for its potential anti-inflammatory and analgesic properties, which might help alleviate the symptoms of primary dysmenorrhea. Additionally, Integrated Yoga Therapy, which combines physical postures, breathing exercises, and meditation, has been shown to improve overall health and reduce stress, which could potentially mitigate the severity of menstrual pain.This study aims to compare the efficacy of Jeeraka Churna and Integrated Yoga Therapy in the management of Udavartini Yonivyapad (Primary Dysmenorrhea).
By conducting an open label double arm randomised controlled clinical study to compare the efficacy of Jeeraka churna and integrated yoga therapy in udavartini yonivyapad, primary dysmenorrhea, in age group of 18-25 years. During the study period 60 patients will be recruited and divided into 3 groups. Group A (Trail group) with oral administration of Jeeraka churna - 1.5g BD dosage with 50 ml of Ushna jala B/F. Group B (Trail group) with suryanamaskara practice for 15 min, 5min of Pranayama followed by 10min of Yoga nidra during non menstrual days and practice of Yoga nidra alone for 10min in the morning hours. Group C (Control group) with oral administration of Tab. Mefenamic acid 250mg in BD dosage during first 3days of menstruation. Statistical analysis will be done on 1st day, 30th day, 60th day and 90th day of menstrual cycle.The outcomes of this research could offer valuable insights into non-pharmacological and holistic approaches to managing primary dysmenorrhea, potentially providing new treatment options that are safe, effective, and accessible.
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 25.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Patients fulfilling the diagnostic criteria, having score 5-7 on VAS scale with Painful menstruation for atleast 3 Consecutive cycles.
- •2.Age group 18-25 years 3.Patient with regular menses.
排除标准
- •Patient with Congenital uterine anomalies leading to Dysmenorrhea
- •Patients with any systemic illness like DM ,HTN.
- •Patient with IUCD
- •Patient with pelvic pathology like pelvic inflammatory diseases,Fibroid uterus,Adenomyosis
- •Patients taking oral contraceptive pills.
结局指标
主要结局
1.VAS(Visual analogue scale)
时间窗: baseline,30day,60day,90day
2.VMSS( Verbal multidimensional scoring system)
时间窗: baseline,30day,60day,90day
次要结局
- Improvement in quality of life according to WHOQOL-BREF(baseline,30day,60day,90day)
研究者
Dr Shravya M Jain
SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka, 560074, India
