A Comparative clinical study to evaluate the efficacy of Shatapushpa Churna and Shatavari Churna in Aartavadushti With Special Reference to Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Shatapushpa Churna is more effective in comparison with Shatavari Churna in menstrual regulisation PCOS.
研究概览
简要总结
TITLE:
A Comparative clinical study to evaluate theefficacy of Shatapushpa Churna and Shatavari Churna in Aartavadushti With Special Reference to Polycystic Ovarian Syndrome
TRIAL DRUG: Shatapushpa Churna
*CONTENTS:*Shatapushpa
ASSESSMENTCRITERIA:
Assessment willbe made on change in clinical features before and after treatment. To assessmenstruation
To assess volumeof ovary To assess hormonal changes
SUBJECTIVE CRITERIA:The patientsundergoing the treatment will be assessedon the basis of symptomsrating score depicted belowfor improvement in specific symptoms of PCOS.
1. MENSTRUATION:
| IMP (DAYS) |
GRADE
SCORE
|28 days
Nil
0
|28-45 days
Mild
1
|45-60 days
Moderate
2
|Above 60 days
Severe
3
2.ASSESSMENTOF OVARIAN VOLUME:
| OVARIAN VOLUME |
SCORE
|5-10
0
|10-15
1
|15-20
2
|>20
3
3.DURATION OF MENSTRUAL FLOW:
| DAYS |
SCORE
|3-5
0
|<3
1
|<2
2
|<1
3
4.QUANTITY OF MENSTRUAL BLOOD:
| GRADE 0 |
2 pad used
|GRADE 1
1 pad used
|GRADE 2
Spotting with pads
|GRADE 3
0 pad used (no menstrual blood even
spotting)
OBJECTIVE CRITERIA:
USG-volume ofovary
Sr.LH
Sr.FSH
Sr.Testosterone
FINAL ASSESSMENT:In view of changes in grade ofclinical features,it was declared as follows-
Complete cure100% free from chief complaint (irregular,scanty and heavy menstruation revertback to normal menstruation)
Maximumimprovement-75% to < 100% improvement of the clinical features. Moderateimprovement-50% to < 75% improvement of the clinical features. Mildimprovement-25% to < 50% improvement of the clinical features.
No improvement- <25% or noimprovement in both subjective and objective parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women between 18-40 years both married and unmarried.
- •All cases of PCOS having amenorrhoea and / oligomenorrhoea.
- •PCOS patients having signs of hyperandrogenism.
- •Presence of polycystic ovaries by ultrasound.
- •a)Presence of multiple >12 follicular cysts measuring about 2-9mm in diameter.
- •b)Ovarian volume is increased >10cm3.
排除标准
- •Uterine fibroid, polyp, adenomyosis, tubercular endometriosis, ovarian mass and tumour.
- •K/C/O Diabetes Mellitus, hypertension, thyroid.
- •Congenital adrenal hyperplasia; Congenital absence or deformities of uterus and ovaries.
- •Patients having congenital anamolies in female genital tract Pregnant women.
结局指标
主要结局
Shatapushpa Churna is more effective in comparison with Shatavari Churna in menstrual regulisation PCOS.
时间窗: PATIENT WILL BE FOLLOWED UP ONCE A MONTH FOR 3 CONSEQUENT MONTHS.
次要结局
- Shatapushpa Churna is not effective in comparison with Shatavari Churna in menstrual regulisation in PCOS.(PATIENT WILL BE FOLLOWED UP ONCE A MONTH FOR 3 CONSEQUENT MONTHS.)