A Clinical Study on Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome of the clinical study on Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea) is the reduction in pain intensity or severity of dysmenorrhea symptoms, assessed using the Walidd score and pain intensity grade scale. This assessment is conducted during the first 3 days of menses, followed by monitoring after 15 days. The same assessment format is repeated in the subsequent cycle.
研究概览
简要总结
To assess the efficacy of Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea) in alleviating pain and discomfort and improving the quality of life.
Study design single-arm open-label study. Duration of trial 14 days for 30 patients suffering from pain, discomfort (Primary Dysmenorrhea) and the scanty or average amount of menses during regular menstrual monthly cycle.
Route: oral
Dosage: 20 ml bd (7 days before the expected date of menses)
Patients will be selected based on inclusion and exclusion criteria and assessed accordingly.
A Plain Empty Filter Paper Tea Bag sachet will be taken and filled with coarse powder of 5 drugs ( Pippali, Marich, Sunthi, Ajwein, Hingu) which is to be dipped in 20 ml hot water for 5-7 mins and to be administered orally (Phanta Kalpana).
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研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients coming with chief complaint of Kastartava [Primary dysmenorrhea] with scanty or average amount of menses (both married and unmarried) for more than 2 consecutive cycles.
- •Female patients in the age group 14 to 35 years of age.
- •Female patients with a history of using analgesics.
排除标准
- •Female patient with a history of any systemic illness.
- •Female patients with menstrual irregularities.
结局指标
主要结局
The primary outcome of the clinical study on Pippalayadi Phanta on Kashtartava (Primary Dysmenorrhea) is the reduction in pain intensity or severity of dysmenorrhea symptoms, assessed using the Walidd score and pain intensity grade scale. This assessment is conducted during the first 3 days of menses, followed by monitoring after 15 days. The same assessment format is repeated in the subsequent cycle.
时间窗: 7 days each month prior to expected date of menses (2 month consecutive cycle)
次要结局
- 1) If the use of herbal hot infusion results in significant reduction in pain intensity & improved quality of life, this natural remedy could offer a safe & accessible alternative to traditional medications to provide valuable insights into the use of herbal remedies for managing primary dysmenorrhea.
研究者
Divya Pariyani
Post Graduate Institute of Ayurved DSRRAU Jodhpur