A RANDOMISED OPEN LABELLED COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF SHOOLAHARA KASHAYA AND YAVADI UTKARIKA AS A SINGLE THERAPIES AND IN COMBINATION ON PAIN MANAGEMENT IN ENDOMETRIOSIS RELATED TO SECONDARY DYSMENORRHEA
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Dysmenorrhea is a common gynecological condition characterized by painful menstruation severe enough to interfere with daily activities. It is classified into primary dysmenorrhea (without pelvic pathology) and secondary dysmenorrhea, which occurs due to underlying pelvic pathology, most commonly endometriosis.
Endometriosis is defined as the presence of functioning endometrial glands and stroma outside the uterine cavity. It affects approximately 10–15% of reproductive-age women and up to 70% of women with chronic pelvic pain. Its prevalence is higher among infertile women (30–40%). The rising prevalence is attributed both to lifestyle factors (delayed marriage, postponed conception, small family norms) and improved diagnostic techniques like laparoscopy.
Pain severity in endometriosis does not always correlate with disease stage, indicating complex pain mechanisms. Despite hormonal therapy and surgical management, many women continue to suffer from persistent pain, reduced quality of life, anxiety, and infertility, highlighting the need for alternative therapeutic approaches.
In Ayurveda, secondary dysmenorrhea can be correlated with Kashtartava, Vatiki Yonivyapada, and Udavartini Yonivyapada. Pain (Shoola) is primarily due to Vata vitiation, particularly Apana Vayu dushti. The principle of management focuses on Vatanulomana to maintain normal Artava Pravruti . Classical references from Acharya Charaka, Sushruta, and Vagbhata emphasize Vata as the key etiological factor in Yoni Roga.
The present study aims to evaluate the efficacy of Shoolahara Kashaya (oral) and Yavadi Utkarika (local application) in managing endometriosis-related secondary dysmenorrhea, addressing the current gap in Ayurveda-based, non-hormonal, non-invasive pain management strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women of reproductive age group 20-50 years.
- •2.Participant clinically diagnosed with Endometriosis meeting one of the following criteria (confirmed by pelvic and rectal examination or ultrasound or laparoscopy).
- •3.Participant with any classical symptoms of secondary dysmenorrhea associated with Endometriosis.
- •4.History of Secondary dysmenorrhea with diagnosed Endometriosis 5.Regular menstrual cycles.
- •6.Participants with mild, moderate and severe pain based on NRS scoring.
- •7.Participant willing for trial will be selected and willing to participate in follow-up.
排除标准
- •1.Participant diagnosed with Primary dysmenorrhea without any underlying pathology 2.Participant diagnosed with other pelvic pathologies like, uterine fibroids (Leiomyomas), PID, or malignancy of reproductive organs other than Endometriosis 3.Participant with chronic systemic diseases such as hypertension, uncontrolled diabetes, renal failure,Thyroid.
- •4.Participant with condition associated with the absence of regular menses Polycystic-ovarian syndrome, pregnant women and Lactating women.
- •5.Participant with an intrauterine device (IUD) or History of metallic implants,history of metallic injury.
- •6.Participants with less than 6 months of postpartum phase, post-abortion, or post-pregnancy at the time of entry into the trial.
- •7.Participant with unexplained irregular uterine bleeding.
- •8.Participant on recent hormonal therapy 9.Participant who is not willing for trial and not willing to participate in follow-up.
研究者
DrApurva Ajit Dongare
Sri Sri College Of Ayurvedic Science and Research Hospital , Bangalore