跳至主要内容
临床试验/CTRI/2024/08/072060
CTRI/2024/08/072060尚未招募2 期

An Open Label Randomised Comparative Clinical Study- To Evaluate The Combined Effect Of Yoga And Naturopathy Techniques In Polycycstic Ovarian Syndrome(Pcos)

DR. JANHVI GOMARE1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
REGULARITY OF MENSTRUAL CYCLE AND REDUCTION OF OVARAIN CYST SIZE

研究概览

简要总结

Polycystic ovarian syndrome or PCOS is a multifactorial and polygenic condition. PCOS is one of the most common Hormonal disorders among women in reproductive age group. The incidence varies between 0.5 to 4% more common amongst infertile women. It is prevalent in young reproductive age group 20 to 30%. Polycystic ovary may be seen in about 20% of normal women1. In this condition, the ovaries of the woman may become enlarged and they may develop numerous harmless fluids filled sacs (follicles). These follicles are underdeveloped sacs which are meant for developing eggs – in PCOS, these follicles fail to release the matured eggs. Following unhealthy Food patterns, sedentary lifestyle, hormonal imbalance, stress and insulin resistance leads to PCOS. Treatment is primarily targeted to correct the biochemical abnormalities, weight reduction, management of hyperandrogenemia, metabolic syndrome, hyperinsulinemia, endometrial hyperplasia, ovulation induction, insulin sensitizers and surgery which is expensive as well as can lead to complications2. The yoga therapy or ‘yoga chikitsa’ refers to the treatment of diseases by means of yogic exercises which may be physical or mental or both. This mode of treatment has been practiced in India from very ancient times. Yoga aims at obtaining relief from pain and suffering. Konasanas are the sets of asanas help to develop and tone the muscles, has favorable effect on the abdominal and pelvic organs as they get compression alternatively and aids good circulation. Naturopathy is the system in which natural elements are used such as panchamahabhuta are used to treat the diseases3. Hydrotherapy is one among the naturopathy treatment which elements the morbid matter and improves the circulation to the organs of the body. It is a need of hour to find out the natural, cost effective and safe methods to treat the PCOS. With this background, the present study is designed to evaluate the combined effect of selected yoga and naturopathy techniques in PCOS.

Group A 20 Subjects and Group B 20 Subjects

Intervention of the study:-

GROUP ASelected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning except during menstruation period.Asanas: - Practicing following asanas 2 rounds each minimum 30 seconds holding in final posture -Parshvakonasana, Parivritta Konasana, Trikonasana, Parivritta Trikonasana, Upavishta Konasana, Suptakonasana, Baddhakonasana.GROUP BSelected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning along with Neutral hip bath for 20 minutes everyday evening except during menstruation period.

Assessment schedule:  

subjects are assessed on 0th day, 31st day, 61st day and 91st day.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Age group 18-40 years old females.
  • Subjects diagnosed with PCOS as defined by Rotterdam criteria.

排除标准

  • Subjects below 18 years of age and above 40 years old Subjects already on other drug treatment for PCOS like OC Pills etc Subjects with known cases of systemic disorders like hypertension, renal disorders, and metabolic disorders like diabetes mellitus, thyroid dysfunction.
  • Subjects with ovarian fibroids, carcinoma.
  • Pregnant women and lactating mothers Subjects who are not willing to participate in the study.

结局指标

主要结局

REGULARITY OF MENSTRUAL CYCLE AND REDUCTION OF OVARAIN CYST SIZE

时间窗: 31st day and 61st day

次要结局

  • Reduction Ferriman-Gallwey Score , BMI (Body mass index), Investigator Global Assessment Of Acne.(31st day, 61st day, 91st day)

研究者

发起方
DR. JANHVI GOMARE
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR JANHVI MAHADEV GOMARE

Rajiv Gandhi University Of Health Science , Banglore

研究点 (1)

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