Randomized comparative clinical trial to evaluate the efficacy of Chaturbeeja Churna with and without Rajaswala Paricharya on Premenstrual Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study is a Prospective,Randomized,Open-label,ComparativeClinicalT****rial designed to evaluate the efficacy of Chaturbeeja Churna with and without Rajaswala Paricharya in the management of Premenstrual Syndrome (PMS). A total of 100 women aged 18–45 years**,** fulfilling PMS diagnostic criteria as per the American College of Obstetricians and Gynecologists, will be randomly allocated into two groups.
The intervention will be administered over three consecutive menstrual cycles**.**Group A will receive oral Chaturbeeja Churna along with Rajaswala Paricharya, while Group B will receive Chaturbeeja Churnaalone. The primary outcome will be assessed using the **Daily Record of Severity of Problems (DRSP)**scale. Secondary outcomes will include assessment of quality of life using the WHOQOL-BREF scale and evaluation of inflammatory markers **(CRP and ESR).**Safety will be monitored by documenting adverse drug reactions throughout the study.
The study aims to assess the comparative efficacy and additional benefit of Rajaswala Paricharyawhen used alongside Chaturbeeja Churna in PMS management.
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 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Regular menstrual cycle of 21–35 days Women (married or unmarried) who are able to sign informed consent and demonstrate cooperative behaviour Fulfilling American College of Obstetrics Gynecology criteria for PMS Willing to participate and comply with treatment and follow up for the 2 month duration of the study.
排除标准
- •Irregular menstrual cycles Symptoms present for less than 2 cycles Participation in any clinical trial within 1 month Currently pregnant or breastfeeding History of mental disorders or ongoing psychiatric medication Known case of systemic disorders (e.g., hypothyroidism, heart disease, kidney disease, circulatory disorders, malignancy) Known drug allergies Diagnosed pelvic pathology on ultra-sonography.
研究者
Diksha Khathuria
Madan Mohan Malviya Govt. Ayurved College, Udaipur
