跳至主要内容
临床试验/CTRI/2024/12/078802
CTRI/2024/12/078802尚未招募2/3 期

A Randomized Open Labelled Controlled Clinical Study To Evaluate The Efficacy Of Amlakyadi Ghrita And Shatavari Ghrita Nasya In The Management Of Rajonivrittijanya Lakshanas w.s.r. Post Menopausal Syndrome

Dr Nidhi Bhawsar1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年2月1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
42
试验地点
1
主要终点
The Proportion of patients showing improvement in the level of Serum Estradiol post nasyakarma

研究概览

简要总结

Rajonivritti is a significant event in woman’s life.It represents the end of the reproductive era.The ancient acharyas termed it as Rajonivritti.This word is derived from Rajah and Nivritti meaning cessation of Artava pravritti. According to Acharya Sushrut & various other refererences 50 years is mentioned as the age of rajonivritti when the full body is fully in grip of senility.Menopause is the permanent cessation of menstruation for 12 consecutive months due to loss of ovarian activity.2 Every women faces various physiological & psychological changes during this change of life as a part of hormonal derangement sometimes such disturbances attains the stage of disease or syndrome called as menopausal syndrome accompanied by Vasomotor, psychological, genital. Locomotor and GIT related symptoms.In menopause menstrual cycle stops and sex hormones level decreases including that of estrogen.Menopause is linked with ageing which is vata dominant stage of life,therefore symptoms of menopause experienced by some women are similar to vriddhi lakshanas of vata dosha.There is connection between nasa and shira. Nasa is considered as a gate way for the shira. When we administered the drugs through nasal route, through the sukshmastrotas in nasal route it reaches the shiragata marma and spreads throughout the mastishka and takes out doshas from urdhvajatrugata region.Nasya karma is a natural route for delivering, rejuvenating substance to the brain.This may be helpful to women to enter is menopausal phase gracefully.Menopausal symptoms generally occur due to disturbed Vata Dosha. Dhatukshay is responsible for Vata Vruddhi and vitiated Vata Dosha affects various systems in women’s body. From the above theory we can conclude that drugs like amlaki,madhuyashti,shatavari having properties of 2 Rasayana, Vatapitta Shaman and Kapha Vardhan can be helpful for the management of menopausal syndrome. Therefore, it has been believed that working in this area and making a contribution—that is, menopause from an Ayurvedic perspective—is imperative

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
45.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • 1 Patients of age between 45 and 6o years 2 Amenorrhoea for more than or equal to 12 consecutive months 3 Kupermann menopausal index score more than or equal to 15 4 willing and able to participate for 4 weeks.

排除标准

  • 1 Patients with evidence of malignancy 2 Surgical menopause 3 Patients with uncontrolled Diabetes Mellitus(Blood sugar fasting more than 250mg/dL),uncontrolled hypertension (BP more than 160/100 mm of Hg) 4 Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD),, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia,Renal diseases, in the last 6 months.
  • 5 Symptomatic patients with clinical evidence of Heart failure.
  • 6 Any other condition which the Principal Investigator thinks may jeopardize the study.

结局指标

主要结局

The Proportion of patients showing improvement in the level of Serum Estradiol post nasyakarma

时间窗: 1ST Follow up on next day after last sitting | 2nd follow up 7 days after 1st follow up

次要结局

  • 1 Reduction in symptoms of rajonivritti in the patients(2 Assessment of rajonivritti by clinical features and post menopausal syndrome by)

研究者

发起方
Dr Nidhi Bhawsar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nidhi Bhawsar

Institute For Ayurved Studies And Research Kurukshetra Haryana

研究点 (1)

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