跳至主要内容
临床试验/CTRI/2025/06/089243
CTRI/2025/06/089243尚未招募2/3 期

Randomized controlled clinical study to evaluate the efficacy of kulatthadi kashay in management of udavartini yonivyapad (primary dysmenorrhea)

C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 4310011 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月28日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Lakshanas of Udavartini Yonivyapad will decrease

研究概览

简要总结

In Ayurvedic classics Gynaecological disorders have been described  under caption Yonivyapad. Among them Udavartini Yonivypad given by  Acharya Charak is closely related to the symptoms of Primary Dysmenorrhea. Here Vata vitiated by vegadharana pushes the menstrual blood upward and then expel it out with difficulty leading to pain. Pain will relieve by itself once the menstrual flow starts, which itself indicate the spasmodic nature of pain. Acharya Sushrut said such symptoms in Udavarta Yonivyapad, the women eliminates frothy menstrual blood with difficulty. Acharya Vagbhat also mentioned Vata aggravated by suppression of the urges, torments the vagina and expels frothy menstrual blood with difficulty.  All classical Samhitas like Charak Samhita, Sushrut Samhita, Vagbhat Samhita have mentioned Udavartini/Udavarta/ Udavritta Yonivyapad respectively as Vataj Yonivyapad. So Vatanulomak and Vatashamak dravyas have main role in treatment. Kulatthadi Kashay is one among lots of herbal preparation which has indication in Udavarta and shul.

Prevalence of Dysmenorrhea in India is 70.2%. Majority of subjects experienced pain for 1-2 days during menstruation. 23.2% girls experienced pain for 2-3 days during menstruation. It is responsible for highest incidence of absenteeism resulting in loss of work hours and economic loss. Hence these females are forced to take antispasmodic, analgesics, prostaglandin synthetase inhibitors etc. during menstruation. However Prostaglandin synthetase inhibitors are contraindicated in women with gastrointestinal ulcer and bronchial asthma. Side effects includes nausea, vomiting, blurred vision,

nephrotoxicity and gastric ulcer on prolong use.

Previous studies on Udavartini Yonivyapad primarily focused on various types of Basti, and there are very few studies on oral medication. This reveals the necessity of alternate treatment to tackle this situation with suitable remedies. Kulatthadi Kashay mentioned in Sahasrayoga containing drugs which are Kulattha, Lahsun, Erand, Patha, Granthik, Nagar and Yavkshar having properties of Dipan, Pachan, Anuloman and Vedanashaman. Previously no research was done on Kulatthadi Kashay, considering above facts it is selected for study.

Study will be conducted on 100 diagnosed patients of Udavartini Yonivyapad. Written consent will be taken. Initial assessment will be done. Patient treated with interventional group Kulatthadi Kashay and control group Shatapushpa Churna. Patients will be assessed at follow ups. Observation and Results will be noted and Statistical Analysis, Discussion and Conclusion will be drawn.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
10.00 Year(s) 至 24.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed patients of Udavartini Yonivyapad of age group from 10 to 24 years young unmarried patient.
  • Patient having chief complaints of painful menstruation with associated symptoms without any pelvic pathology.

排除标准

  • Patients of age group below 10 & above 24 years married patients.
  • Patients of pelvic pathology i.e. PID, PCOD, Cervical stenosis, Fibroid, Endometriosis, DUB, Adenomyosis, Endometrial polyp.
  • Patient taking any hormonal therapy.
  • Patient with congenital anomalies of reproductive system.
  • Menorrhagia.

结局指标

主要结局

Lakshanas of Udavartini Yonivyapad will decrease

时间窗: Baseline-30th, 60th day

次要结局

  • 1.Study Udavartini yonivyapad according to(Ayurveda.)

研究者

发起方
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001
申办方类型
Private medical college

研究点 (1)

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