A randomised controlled clinical trial to evaluate the effect of Rasonadi churn in the management of Anovulatory cycle.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Rupture of follicle
研究概览
简要总结
Title:
"A Randomised Controlled Clinical Trial to Evaluate the Effect of Rasonadi Churna in the Management of Anovulatory Cycle"
INTRODUCTION-
The creator of universe has empowered the women to carry out the most noblest work of mankind and that is the work of Reproduction.Numerous factors contribute to infertility, including dietary changes, stress, and a decrease in physical activity that alters menstruation patterns and triggers anovulation.Many patients with these diseases are dissatisfied with the current treatment, which involves hormone therapy. Thus, it’s imperative to treat the anovulation cycle, which eventually leads to infertility, using herbal formulations that have the fewest negative effects and restore the scent of life in women.Thus, there is a great need for study to identify an inexpensive, effective, and less side effect ayurvedic medication for the treatment of vandhyatva. Thus, this study has made an attempt in that regard.In kashyap Samhita kalpa sthan ,in Lasunkalpa adhyaya use of Rasonkalpa in various gynaecological disorders is well explained.
Rasona is with Snigdha,Ushna ,tikshna, guru quality and also in katu rasa helps to regulate the menstrual flow and ovarian function.Rasona , twak, tejpatra, shunthi, marich, ela, saindhav with its ushna tikshna guna does deepan and pachan and vatakaphashamak.
RESEARCH QUESTION :-
Is Rasonadi churn with ghrut effective in anovulatory cycle ?
HYPOTHESIS :-
Null Hypothesis:-
There is no effect of Rasonadi churn with ghrut in anovulatory Cycle.
Alternative Hypothesis:-
Rasonadi churn with ghrut is effective in anovulatory cycle.
Aim:-
To study the effect of Rasonadi churn with go-ghrit in Anovulatory cycle.
Primary Objective:-
To study the Effect of Rasonadi churn with go-ghrit In Anovulatory Cycle.
Secondary Objectives:-
- To study the effect of Rasonadi churn with go- ghrit on
1.Follicular size
2.Regularity of menses
Methodology:
Design: Randomized controlled trial
Groups:
Group A: Rasonadi Churna with Go-Ghrita
Group B: Shatavari-Shatapushpa Churna with Go-Ghrita (control)
Dose: 5 gms orally, twice daily, from 5th day of menses for 2 consecutive cycles
Sample Size: 35 patients per group
Criteria: Follicular size, ovulation, regularity of menstruation
Assessment Parameters:
Subjective: Menstrual interval, duration
Objective: Follicular rupture, follicle size, ovulation on follicular study
Expected Outcome:
To demonstrate statistically significant improvement in ovulation and menstrual regularity in the Rasonadi Churna group compared to control.
Observation and Results:
Observations and results will be drawn according to assessment criteria.
Discussion:-
Discussion will be done according to observation table.
Conclusion:-
Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.
Summary:-
On the basis of observation and discussion, summery of total clinical trial will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •1-All prediagnosed patients having anovulatory cycle or unruptured ovarian follicle.
- •2-Married patients 3-Patients having may or may not be associated with PCOS pattern,scanty,regular,irreregular menses.
排除标准
- •1-Patients with Chronic systemic diseases like Diabetes 2-Patients suffering from disoreders of reproductive tract like congenitaldeformities,suspected cases of CA cervix etc 3-Patients with HIV,HbsAg,VDRL positive 4-Uterine synchiae ,uterine fibriods etc.
- •5-Endometriosis 6-Endometrial carcinoma.
结局指标
主要结局
Rupture of follicle
时间窗: 8week
次要结局
- 1-Folliclar size(2-regularity of menses)
