Randomised Controlled Clinical Trial To Evaluate The Shulaghna Effect Of Hingvadi Churna In The Management Of Udavartini Yonivyapad With Special Reference To Primary Dysmenorrhia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Significantly reduction in pain during menses
研究概览
简要总结
:
Primary objectives- To study the shulaghna effect of Hingvadi Churna in the management of
Udavartini Yonivyapad with special reference to primary dysmenorrhea.
-To find whether Hingvadi churna is more effective than Yavani churna in Udavartini Yonivyapad
Secondary objectives-
To study the effect of Hingvadi Churna on-
Artava praman(menstrual flow)
Praseka(nausea)
Pain in other region-kati,vankshan,adhoudar shool
Aruchi(loss of appetite)
Group A - Hingvadi churna
Group B - Yavani churna
Appropriate Sampling Technique: Simple randomised sampling method by computerised random technique will be done for 76 female patients of age group 18 to 70 years.
The subjects will be randomised in two study groups i.e., Group A and B. The time and date of recruitment shall also be recorded in the enrolment log
Follow up: on 5 th day of menstrual cycle
Assessment Criteria: The study will be strictly based on assessment of subjective parameter by the grading them.
The data obtained will be analyzed statistically.
Observation and Results: Observation and results will be drawn according to assessment criteria.
Discussion: The observed phenomena will be discussed.
Conclusion: Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased Summary: The research study will be summarized in brief.
Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant.
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
- 16.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient fulfilling diagnostic criteria patients complaining of pain during menses with other symptoms of Udavartini Yonivyapada for at least three consecutive cycles Patients with age group of 16 to 30 years old.
- •Married and unmarried patients Patient with scanty or average flow.
排除标准
- •Patient having irregular menstruation.
- •Patient having congestive, poly or epi menorrhea Patient having anatomical and congenital anomalies in genital tract.
- •Patient with Fibroid, cyst, endometriosis.
- •Patient suffering from any systemic disease like HTN, DM, bleeding disorder, cardiac disease, APH, PIH.
- •Presence of HIV,HbsAg,VDRL,HPV Positive in the patient.
- •Patient using any IUCDs. Patient having an endocrinological disorder like Hypothyroidism Hyperthyroidism.
结局指标
主要结局
Significantly reduction in pain during menses
时间窗: 2 Consecutive menstrual cycle
次要结局
- Significantly reduction in pain during menses by using Higvadi churna than Yavani churna(2 Consecutive menstrual cycle)
研究者
Dr Nikita Raju Bisen
R A Podar Ayurvedic Medical College Worli Mumbai