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临床试验/CTRI/2024/08/071940
CTRI/2024/08/071940尚未招募3 期

A Randomised Controlled Clinical Trial To Study The Effect Of Bilvadi Yoga In Asrigdara With Special Reference To Abnormal Uterine Bleeding

Dr Shruti Shivaji Zendage1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Reduction in Sign and Symptoms of Asrugdara after Giving Bilvadi Yoga

研究概览

简要总结

Prevalence rate of Asrigdara with special reference to Abnormal Uterine bleeding is 17.9 %. AUB is treated with hormonal therapy, Antifibriolytic agents, prostaglandins synthesis inhibitor and surgical management etc. in modern science which has its own side effects. Ayurvedic treatment for managing Asrigdara could be safe, non surgical , easily available and cost effective without any side effects. Bilvadi choorna has great impact on treating Asrigdara as it has Raktstambhan, vatapittahar, Shothhar and Balya properties. Clinical trial to evaluate efficacy of Bilvadi choorna would be beneficial to expand knowledge about management alternative. A clinical study of Bilvadi choorna has not yet been assessed in Asrigdara . So it will help to fill knowledge gap .

Including the female patient having sign and symptoms of Asrigdara like excessive excretion of menstrual bleeding between age group of 18-50 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group).  Bilvadi choorna to group A (Trial group), Shunthi lodhra with  to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of choorna preparation will be followed throughout the clinical trial. Observation will be done on Oth and 0th ,8th day of 1st,2nd and 3rd menstrual period. Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn, and thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out.

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Patients complaining symptoms of Asrigdara such as excessive and prolonged uterine bleeding with PBAC score is greater than or equal to
  • Female patients with age group 18 to 50 years.

排除标准

  • Patients with Systemic Hemorrhagic Disorders.
  • Patients with Structural abnormalities like Uterine Polyps, Uterine Erosions, Uterine Fibroids, Ovarian mass, Malignancy of Uterus or Cervix, etc.
  • Postdelivery bleeding, Post MTP bleeding, Post D and C bleeding.
  • Patients with Intra Uterine Contraceptive Device.
  • Injuries to Reproductive tract.
  • Systemic disorders like, Diabetes Mellitus, Severe anemia.

结局指标

主要结局

Reduction in Sign and Symptoms of Asrugdara after Giving Bilvadi Yoga

时间窗: At baseline and 7 days Reduction in Sign and Symptoms of Asrugdara after Giving Bilvadi Yoga

次要结局

  • where the trial group stands in comparison with control group(18 months)

研究者

发起方
Dr Shruti Shivaji Zendage
申办方类型
Other [Private ayurved college ]
责任方
Principal Investigator
主要研究者

Dr Shruti Shivaji Zendage

SMBT Ayurved College and Hospital

研究点 (1)

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