AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF SHATAVARI GUDA AND KUSHMANDAKA RASAYANA IN HEAVY MENSTRUAL BLEEDING
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
- bleeding will be controlled
研究概览
简要总结
Women’s health is point of concern for herself, family and society because any physical or mental variations can disturb her normal menstrual cycle.
Regular menstruation is a result of coordinated HPO Axis. The duration of menstrual cycle is usually 28 to 30 days. The duration of bleeding is about five days and estimated blood loss is 20 to 80 ml.[1]
In present days, due to changing lifestyle with food habits, incidence of excessive and irregular menstrual bleeding is increasing day by day because of which women need to take off from the work. Heavy menstrual bleeding affect not just physical but also social, emotional and psychological well being & quality of life.
Heavy menstrual bleeding is the medical term for menstruation with abnormally heavy or prolonged bleeding. International Federation of Gynaecology and Obstetrics (FIGO) Menstrual Disorders Working Group has proposed abandoning the use of one common term, dysfunctional uterine bleeding (DUB), while continuing to use the terms abnormal uterine bleeding (AUB) and heavy menstrual bleeding (HMB). It affects 30% of women during their reproductive years.[2] Prevalence of Menorrhagia in India is 17%.[3]
The diseases Asrigdara explained in Ayurveda may be correlated with condition of heavy menstrual bleeding. According to Acharya Sushruta, excessive and prolonged bleeding during menstruation or even in intermenstrual period, different from the features of normal menstrual blood is called Asrigdara [5] .
Asrigdara or abnormal uterine bleeding is regular or irregular with alteration in amount or duration of menstrual blood loss, commonly implies to excessive irregular menstrual bleeding or essential menorrhagia.
Various conditions which resemble Menorrhagia are termed as follows in Ayurveda Texts-
Raktapradar/Asrigdara
Raktayoni Yonivyapad
Lohitkshara Yonivyapad,etc.
Various treatment modalities like hormonal therapy antiprostaglandins and antifibrinolytic agents are available in modern medicine. Many side effects have been observed, because of these medications,including hormonal imbalance.There is always a need for safe and alternative treatment. Keeping this in mind, It was decided to select a herbal medicine for the management of Heavy Menstrual Bleeding. As per Ayurvedic references SHATAVARI GUDA and KUSHMANDAKA RASAYANA is considered as most useful remedy for Menstrual disorders. The present study focused on the effect of SHATAVARIGUDAandKUSHMANDAKARASAYANAon Heavy Menstrual Bleeding.
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
- 15.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •SUBJECTS FULFILLING THE DIAGNOSTIC CRITERIA 2) SUBJECTS WITH AGE GROUP 15 TO 45 YEARS 3) SUBJECTS WITH HEMOGLOBIN MORE THAN EQUAL TO 10 GRAMS.
排除标准
- •Subjects with IUCD.
- •Subjects on oral Contraceptive pills.
- •Benign and malignant growth in reproductive organs.
- •Subjects with K/C/O metabolic and systemic disorders like Diabetes mellitus, Thyroid disorder, Hypertension.
- •Subjects with miscarriage/active bleeding followed by abortion.
- •K/C/O Coagulation Disorder, H/O previous thrombosis.
- •Lactating women.
结局指标
主要结局
bleeding will be controlled
时间窗: 3 months of continuous use will help in controlling heavy menstrual bleeding
次要结局
- loss of blood due to heavy cycles leads to anemia, which can be prevented(3 months regular use)
研究者
Dr Raut Deepali Lahu
JSS Ayurveda Medical College And Hospital mysuru
