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临床试验/CTRI/2019/10/021722
CTRI/2019/10/021722尚未招募1 期

A clinical study to evaluate the efficacy of indigenous Avaleha formulation in the management of Rajonivrutti lakshnas w.s.r to post menopausal syndrome.

Parul Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月31日最近更新:

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)

研究者

发起方
Parul Institute of Ayurved
申办方类型
Research institution and hospital

研究点 (1)

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