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临床试验/CTRI/2020/12/030096
CTRI/2020/12/030096尚未招募3 期

Randomised controlled clinical study of Rasontail basti in Anovulatory cycle(Abijotsarga) (WHO CLASS2 CLASSIFICATION)

swati pathade1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
106
试验地点
1
主要终点
efficacy of Rasontail matrabsti in anovulatory cycle whether the development of follicle ovulatation occurs on folicilar study

研究概览

简要总结

Motherhood is an ultimate and cherished desire of every woman. when she achieves it, she feel completeness in her life but all woman are not so much lucky to attain motherhood.  This impact on individuals physical and mental health.Modern era is unable to give answer to her questions. the treatment suggested on modern science is though effective , has lots of side effects.Ovarian factors is second most common cause of infertility, contributing about 25 to 35%. here present study will be  based on the referrance available in Kashap samhita kalpsthana.Factors of anovulation will be confirmed by counselling,check up & investigation.Total 106 patient of anovulation will be taken in the study.out of which 53 patient will be subjected to clomiphene citrate and 53 patient will be subjected to the Rason tail matra basti.Tablet clomiphene 100 mg will be given from second day of menstrual cycle for 5 days orally.

This the controlled clinical trial in which  Rason tail matra basti will be given to patient with anovulatory cycle.After emptying bowel in the morning,immediate after taking light food at morning at 9 AM,60 ml Rason tail matra basti will be induced to the patient,Retention time of basti will be noted.Basti will be given from fifth day of menses for 10 days .Treatment duration for 3 months.follow up period will be every menstrual cycle for three consecutive cycles.During the treatment total abstinence will be there.

Inclusion Criteria-

  1. Age group 18 -35 yrs 2) PCOD 3) Irregular / Scanty menses due to anovulatory cycle4) Anriteriaovulation / Oligoovulation 5) delayed ovulation

Exclusion Criteria -

1)Bleeding PV 2)Cervical tumour-polyp,Ca cervix 3)Uterine fibroid 4) Congenital anamalies in female genital tract 5)Tubercular endometritis 6)HIV/VDRL/HbsAg positive 7)Malignant diseased and cytotoxic  patient 8) patient with all systemic disorders.

Hematological investigations will be done.USG pelvis and Follicular study will be done  from 10th day of menstruation till after ovulation with serum FSH,serumLH,serum oestadiol.

The improvment in the symptoms will be assess on the basis of severity.A)subjective criteria is quantity of menstrual bleeding . B)objective criteria 1) folicular size 2) Endometrial Thickness.statistical Analysis will be done by using appropriate stastistical techniques to prove the significance of result.the data will be collected from CRF were then subjected to demographic and statistical  analysis and conclusion will be drawn which will be unbiased.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • •1.PCOD 2.Irregular menses /Scanty menses due to Anovulation 3.Anovulation/Oligoovulation 4.Delayed Ovulation.

排除标准

  • •Bleeding P/V 2.cervical polyp, tumour, Ca Cervix
  • •Uterine Fibroid 4.Congenital anomalies in female genital tract
  • •Tubercular Endometritis 6.HIV/ VDRL/ HbsAg positive 7.Malignant diseased patient and Cytotoxic patient 8.Patient with all systemic disorders.

结局指标

主要结局

efficacy of Rasontail matrabsti in anovulatory cycle whether the development of follicle ovulatation occurs on folicilar study

时间窗: for 3 month . from 5th day of menses for 10 days.

次要结局

  • Dysmenorrhea(scanty menses)

研究者

发起方
swati pathade
申办方类型
Other [self]

研究点 (1)

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