跳至主要内容
临床试验/CTRI/2024/05/067175
CTRI/2024/05/067175尚未招募2/3 期

A Randomized comparative clinical study to evaluate the efficacy of indigenous drugs and pathya ahara vihara in the management of PCOS.

Dr CC Hiremath1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月7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
20
试验地点
1
主要终点
The primary outcome of the study is to prevent the symptoms and to restore menstrual cycle with proper ovulation in women health and to have healthy progeny and to relive the agony of patient with the help of a safe and cost effective medicaments.

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is a common hormonal condition that affects women of reproductive age. It usually starts during adolescence, but symptoms may fluctuate over time. PCOS can cause hormonal imbalances, irregular periods, excess androgen levels and cysts in the ovaries. Irregular periods, usually with a lack of ovulation, can make it difficult to become pregnant. PCOS is a leading cause of infertility. PCOS is a chronic condition and cannot be cured. However, some symptoms can be improved through lifestyle changes, medications and fertility treatments. PCOS a significant public health problem and is one of the commonest hormonal disturbances affecting women of reproductive age. The condition affects an estimated 8–13% of women of reproductive age, and up to 70% of cases are undiagnosed. The prevalence of PCOS is higher among some ethnicities and these groups of often experience more complications, in particular related to metabolic problems. The biological and psychological effects of PCOS, particularly those related to obesity, body image and infertility, can lead to mental health challenges and social stigma.

In Ayurveda PCOS can be correlated to some extent with Artava-kshaya or with Pushpaghni jataharani The symptoms of Artava-kshaya is Yathochita-kala-adarshana means Apravrutti of Artava in its Yogya Kala (it may be delayed or absent), Artava is Alpa in pramana (scanty bleeding) and Yoni-vedana. The symptoms of Pushpaghni Jataharani is Vyartha-Pushpa-darshana (anovular menstruation), Sthula-Ganda-pradesha (cheeks are corpulent)and Lomayukta (hirsutism).

In present era of globalization due to transient change in the life style to a more of  sedentary life style, exercise over time, lack of physical exercise, stress, high caloric food and indiscriminate dietary habits leading PCOS  A medical intervention of polycystic ovarian disease and syndrome includes hormonal therapies which have long term health consequences. There by researchers are looking for the ayurvedic (Herbal) medicine for the treatment of PCOS in alternative medicine which do not causes any side effects. The indigenous drugs namely MC-Norm and PC-Norm which are kapha-vatashamaka, having rochan, deepan, pachan, anulomaka properties. PCOS  is a life style disorder even  here is also an another attempt made to evaluate the effect Placebo – Wheat flour capsule with pathya aahara and vihara in the management of PCOS. Hence the study has undertaken to evaluate the effect of in indigenous compound  in the management of PCOS.

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Rotterdam creteria.
  • With following symptoms of PCOS if any two of the following are present (1) clinical or biochemical hyperandrogenism, (2) Evidence of oligo-anovulation, (3) Polycystic appearing-ovarian morphology on ultrasound (4) Both married and unmarried females.

排除标准

  • 1 Patients suffering from Pelvic diseases like Endometriosis, Hydrosalphinx, Fibroid uterus, T.B, Carcinoma and Congenital deformities.
  • 2 Patients having physiological infrequent menstruation.
  • 3 Woman taking Oral Contraceptive Pills.
  • •Subjects with systemic illness interfering with the study.

结局指标

主要结局

The primary outcome of the study is to prevent the symptoms and to restore menstrual cycle with proper ovulation in women health and to have healthy progeny and to relive the agony of patient with the help of a safe and cost effective medicaments.

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Dr CC Hiremath
申办方类型
Other [Principal Sanjeevini Ayurvedic Medical college and Hospital Hubli Dharwad Karnataka India 580030]
责任方
Principal Investigator
主要研究者

Dr Lavanya Holeyannavar

Rajiv Gandhi University of Health Science Bangalore Karnataka

研究点 (1)

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