跳至主要内容
临床试验/CTRI/2023/06/053629
CTRI/2023/06/053629尚未招募2/3 期

“A Randomized Controlled Clinical Study To Evaluate the Effect of Laksha Choorna in Asrigdara (Dysfunctional Uterine Bleeding).â€

Dr B Manisha Reddy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in Amount & duration of bleeding

研究概览

简要总结

Asrigdara is a common menstrual disorder affecting women. It is characterized by excessive prolonged menstrual or intermenstrual bleeding which interferes with women’s physical, emotional and social quality of life. In modern science it can be correlated with Abnormal Uterine Bleeding. Dysfunctional uterine bleeding is one among Abnormal uterine bleeding without any clinically detectable Organic Cause. The Rate of prevalence of AUB in India is around 17.9%. In contemporary science management protocol includes interventions like Hormonal therapy, Anti prostaglandins and antifibrinolytic agentsand further advices to surgical interventions like uterine curettage, endometrial ablation and Hysterectomy, which has their own limitations, high costs with associated side effects. Ayurvedic classics have described varieties of treatment options in the management of Asrigdara, which are non-hormonal, non-surgical, effective drugs without any adverse effects. Among them Laksha choorna and Pushyanuga choorna are shamana aushadhi’s having properties like kashaya rasa pradhana, pitta shamaka and rakta stambaka in action found to be effective in Asrigdara. Laksha choorna which is a cost effective, commonly available drug and can be prepared easily. Hence the study has been taken as “A Randomized controlled clinical study to evaluate the effect of Laksha choorna in Asrigdara (dysfunctional uterine bleeding)’’.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1 Subjects presenting with pratyatma lakshanas of Asrigdara (Raja atipravruthi,DeerghaKalanubhandhi, Anruthavalpamapi) with Raja atipravruthi as a main symptom.
  • Ages for the study: 20-45years.
  • Subjects ready to sign the informed consent form.

排除标准

  • 1.Participants who are not willing for trial.
  • 2.Structural abnormalities involvement in uterus.
  • 3.Uterine polyp.
  • 4.Carcinoma of cervix.
  • 5.Fibroid uterus.
  • 6.Adenomyosis of the uterus.
  • 7.Coagulation disorders like Haemophilia, Leukaemia, sickle cell anaemia.
  • 8.Systemic diseases like Diabetes mellitus, Hypertension, epileptic disorders.
  • 9.Haemoglobin less than 6 g/dL 10.Women using Intra Uterine contraceptive Devices or oral contraceptive pills.
  • 11.Bleeding after menopause.
  • 12.Miscarriages.

结局指标

主要结局

Reduction in Amount & duration of bleeding

时间窗: fifth day of menstrual cycle for two consecutive menstrual cycles | Observational | Followup fifth day of third Menstrual cycle

次要结局

  • to analyse condtion of asrigdara & treat by ayurveda principles(fifth day of menstrual cycle for two consecutive menstrual cycles)

研究者

发起方
Dr B Manisha Reddy
申办方类型
Other [[self]]

研究点 (1)

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