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临床试验/CTRI/2025/03/082780
CTRI/2025/03/082780招募中2/3 期

A Clinical Study on Effectiveness of Mandukaparnyadi Paniya in Managing Psychological Symptoms During Menopausal Transition

Dr Namratha M V1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Reduction in psychological symptoms such as Anxiety, Depression, Mood swings and sleep disturbances assessed using validated scales like the Menopausal rating scale(MRS)

研究概览

简要总结

Menopause is a physiological process denoted as Rajonivrutti Cessation of menstruation in Ayurveda Menopausal transition is a period which represents the passage from reproductive to non-reproductive life called as perimenopause This commonly occurs in women in their late 40s and early 50s psychological variations are a major concern during menopausal transition like trouble concentrating irritability fatigue depression anxiety sleep disturbances and poor memory when it causes discomfort either to mind or body it requires medical interference The hormonal fluctuations especially oestrogen that occurs during perimenopause can have a marked effect on psychological well-being Perimenopausal symptoms can have a significant impact on a woman s quality of life affecting her physical health emotional well-being and social functioning Symptoms such as hot flashes sleep disturbances and mood swings can interfere with daily activities work productivity and interpersonal relationships Prevalence of psychological symptoms is seen in 80% of women in perimenopausal period Some of the women may be asymptomatic or may have minimal symptoms or the symptoms may go unnoticed Hence there is an acute need to address the mental health status of this age group In contemporary system of medicine this condition is treated with Hormone replacement therapy HRT which is useful in treating vasomotor symptoms sleep disturbance and genitourinary symptoms and less efficient in treating psychological symptoms which is more prevalent in perimenopause Anxiolytics and Anti depressants can also be given but after withdrawal the symptoms reappear patient may become drug dependent Ayurveda literature also recognises the age group around 50 years as the period of Rajonivrutti Menopause During this period women is at the verge of middle age and there is gradual decline in all Dhatus bodily tissues eventually leading to Arthavakshaya cessation of menstruation This is correlated to perimenopausal stage An approach of combined medicinal herbs like shatavari mandukaparni guduchi having properties of Medhya nootropic Rasayana rejuvenation helps in balancing doshas and has phytoestrogen selective oestrogen receptor modulators SERM adaptogen anti-oxidant Thus the current study aimed at restoring mental health of this age group by administering a naturally available herbs as a medicine in the form of Paniya Kalpana which is convenient easy instant preparation in fast moving lifestyle

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Subjects under menopausal transition having irregular menstrual cycles.
  • Subjects who have not undergone Hormone Replacement Therapy.
  • Subjects who are willing to give consent for the study.

排除标准

  • Patients with a history of mental or behavioral disorder.
  • Subjects with excessive bleeding in perimenopause due to artificial or premature menopause.
  • Subjects who attained surgical menopause.
  • Patients diagnosed of major organic pathology of reproductive system like carcinoma, fibroid, ovarian cyst etc.

结局指标

主要结局

Reduction in psychological symptoms such as Anxiety, Depression, Mood swings and sleep disturbances assessed using validated scales like the Menopausal rating scale(MRS)

时间窗: 30days

次要结局

  • Improvement in cognitive function, sleep quality, and overall quality of life(30days)

研究者

发起方
Dr Namratha M V
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Namratha M V

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

研究点 (1)

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