Clinical study to evaluate the effect of Shatapushpa Arka in the management of Primary Dysmenorrhea in young adult females.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in spasmodic lower abdominal pain as assessed in VMSS.
研究概览
简要总结
Dysmenorrhea is a common gynecological complaint among adolescent and young adult females. Dysmenorrhea is usually primary and is associated with normal ovulatory cycles and with no pelvic pathology. Primary Dysmenorrhea (ICD 10 diagnosis code- N94.4) refers to the presence of recurrent cramping pain in the lower abdomen during menstruation. Primary Dysmenorrhea (PD) negatively impacts the Quality of Life by hampering the productivity and ability to perform their day to day activities. A cross-sectional study has shown 70.2% prevalence of dysmenorrhea in South Indian females aged 11-28 years. The goal of treatment is to provide adequate relief of pain. In contemporary science, NSAIDs, especially mefenamic acid, are the treatment of choice for Dysmenorrhoea. However they impart certain adverse effects, including indigestion, headaches and drowsiness etc. Due to the rising awareness about the substantial risk of adverse effects of these NSAIDs, considerable numbers of patients approach for Ayurvedic treatment. Hence Dysmenorrhea is one of the common clinical entities encountered in regular Ayurvedic practice.
In Ayurvedic classics, dysmenorrhea can be termed as Kashtartava. Kashtartava is a symptom in disease Udavartini Yonivyapat.
Ayurveda denotes the involvement of Vata in all different kinds of pain. The function of Apana Vayu is ensuring physiological downward expulsion of Artava. So any de-arrangement of Apana Vata causes painful menstruation. Therefore to reduce the symptoms of pain, Vata Anulomana (Normal course of movement of Vata) and Vatahara (Vata-pacifying), is the choice of treatment. Many Dravyas are mentioned in Ayurvedic Classics for Kashtartava, out of which Shatapushpa is one of them. Shatapushpa (Anethum graveolens Linn.) can be used in treatment of pain and other associated symptoms of dysmenorrhea as it is Vatahara, Yoni Shulaghna and also Vata Anulomana. Clinical trials on Shatapushpa in the form of Phala Churna and Shatapushpyadi Taila have proven significant effects in the management of Kashtartva.
Phytochemical constituents of Anethum graveolens Linn. include volatile components, coumarins, terpenoids, flavonoids, phenolic acids and steroids. The terpenoid-carvone has antispasmodic effect. The flavonoid quercetin also has the ability to reduce PGF2α-elicited Ca2+ responses in human uterine smooth muscle cells and inhibit Ca2+-dependent uterine contractions. Other volatile compounds like α-phellandrene, limonene have analgesic effects too .
Arka Kalpana is a unique pharmaceutical preparation in Ayurveda in which the volatile oil and active principles of a drug are collected by the process of distillation. Arka is the most efficacious and stable dosage form as explained in Arka Prakasha. So this study aims to administer Shatapushpa in the form of Arka (distillate). Hence this study is intended to evaluate the effect of Shatapushpa Arka in the management of PD in young adult females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 24.00 Year(s)（—）
- 性别
- Female
入选标准
- •Single (unmarried), young adult females between 20 and 24 years of age.
- •Subjects having regular menstrual cycles in the interval of 21–35 days and bleeding duration of 3-7 days.
- •Subjects suffering from pain during menstruation for more than 2 consecutive menstrual cycles.
- •Lower abdominal and pelvic pain associated with onset of menses.
- •Onset of pain within 6–12 hours after onset of menses and pain lasting for 9–72 hours.
- •Subjects of Grade 1, 2 and 3 on the Verbal Multidimensional Scoring (VMS) System.
排除标准
- •Female subjects with known history of Secondary Dysmenorrhea, Pelvic pathology, endometriosis, tubercular endometritis, polycystic ovarian syndrome.
- •Female subjects with known history of thyroid, pituitary and hypothalamic abnormalities, general diseases like tuberculosis, nephritis, diabetes and heart diseases.
- •History of any other surgical and neurological condition or surgery resulting in Dysmenorrhea.
结局指标
主要结局
Reduction in spasmodic lower abdominal pain as assessed in VMSS.
时间窗: Mentruation related spasmodic lower abdominal pain relief within 3 days of administration of trial drug.
次要结局
- Reduction in Associated Symptoms of Primary Dysmenorrhea as assessed in CMSS.(Relief within 3 days of administration of trial drug.)
研究者
Sharanya CB
SDMIAH BANGALORE