A clinical study to evaluate the efficacy of indigenous Avaleha formulation in the management of Rajonivrutti lakshnas w.s.r to post menopausal syndrome.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- improvement in symptoms clinical features of post menopausal syndrome
研究概览
简要总结
Menopause means permanent cessation of menstruationat the end of reproductive life due to loss of ovarian follicular activity. It is the point of time when last & finalmenstruation occurs. The clinical diagnosis is confirmedfollowing stoppage of menstruation(Amenorrhea) for twelve consecutive monthswithout any other pathology. Age at which menopause occurs is geneticallypredetermined.The age of menopause ranges between 45-55 years, average being50years.
According to Sushruta menstruationstarts at the age of 12 years & continuing in regular period (every month)stops at the age of 50 when the body is fully in grip senility.Women are affected in varying degrees by the uncomfortable symptoms that can accompanymenopause such as irregular menstrual cycles, hot flushes, disturbed sleeppatterns, vaginal discomfort, and the emotional difficulties.About 60% ofwomen approaching the age of menopause experience some symptoms due tobiochemical changes taking place within. Symptoms often subsides naturally asthe menopausal years progress .Other women experience symptoms suddenly or veryintensely, and seek medical relief for their debilitating effect. In the Modern medicine HormoneReplacement Therapy(HRT) has been mentioned but there are a lot of riskassociated with HRT like Endometrial cancer,Breast cancer, venousthromboembolic(VTE)disease,Coronary heart disease(CHD),Lipid metabolism,DementiaAlziemer. So it is the need tofind efficient, economic, natural and safer formulation to manage postmenopausal syndrome.
In this study drugslike Shatavari, Shankhpuspi, Jatamansi,Brahmi Sarpgandha ,Durva, Guduchi,Udumber,Bala, Aswagandha ,Arjun, Asthi shrunkhala and Godanti are taken. These durugshave laghu sinigdhaguna and madhur rasa and sheet virya having Balya,Medhya,Nidrajanan and rasayan properties. With all these drugs we areformulating avalehakalpana.
AIMToEvaluate the efficacy of Indigenous drugs on post menopausal syndrome.(Rajonivruttilakshanas)
OBJECTIVESTo study in detailrajonivruttilakshanasw.s.r to post menopausal syndrome according to ayurvedicand modern science.
HYPOTHESIS:- I. Null hypothesis: Avaleha formulation of indigenous drugs are noteffective in the management of post-menopausal syndrome.(ie. Rajonivruttilakshanas).
II. Alternate hypothesis: Avaleha formulation of indigenous drugs are effectivein the management of Post-menopausal syndrome. (RajonivruttiLakshanas).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •Back ache vaginal dryness hot flushes excessive sweating headache mood swings depression sleep disturbance.
排除标准
- •pre mature menopause(before 40 years) any pre-exisiting psychological disorders delayed menopause diabetes mellitus surgical menopause disc problem any systemic disorders.
结局指标
主要结局
improvement in symptoms clinical features of post menopausal syndrome
时间窗: 3 month
次要结局
- improvement in general health(improvement in symptoms)
