Studying effectiveness of individualised homoeopathic medicine in the management of polycystic ovary syndrome among females of reproductive age group-A randomised controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- USG changes and symptomatic relief in polycystic ovary syndrome cases
研究概览
简要总结
TITLE-STUDYING EFFECTIVENESS OF INDIVIDUALISED HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF POLYCYSTIC OVARY SYNDROME AMONG FEMALES OF REPRODUCTIVE AGE GROUP - A RANDOMISED CONTROLLED STUDY
INTRODUCTION - Polycystic Ovary Syndrome (PCOS) is one of the most prevalent endocrine system condition, adversely influences the fertility and reproductive health of women of reproductive age. Polycystic Ovary Syndrome is defined by a combination of signs and symptoms of androgen excess and ovarian dysfunction in the absence of other specific diagnoses (1,2). The World Health Organization (WHO) estimates Polycystic Ovary Syndrome affects 8 to13% of reproductive aged women globally, up to 70% of affected women remain undiagnosed worldwide. The prevalence rate of Polycystic Ovary Syndrome is high among Indian women, it ranges from 3.7 to 22.5%. One in every 10 women in India has polycystic ovarian syndrome, and out of every 10 women diagnosed with Polycystic Ovary Syndrome, six are teenage girls. (6)
Background-Although Polycystic Ovary Syndrome can occur at any age, beginning with menarche, and the majority of instances are identified between the ages of 20 and 30years. Polycystic Ovary Syndrome is associated with a variety of long-term health problems that affect physical and emotional wellbeing. The exact cause of this multifactorial disorder is unknown, a combination of inherited and environmental factors is thought to play a primary role. (3, 4)
This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity affecting 60-70% of people. Beyond physiological manifestations, polycystic ovary syndrome is associated with anxiety, depression, eating disorders, psychosexual dysfunction and negative body image, collectively contributing to diminished health-related quality of life in patients. Also, it increases the risk of related comorbidities such as type I diabetes &cardiovascular complications. (13)
The treatment of Polycystic Ovary Syndrome is as complex as the disorder itself, since the clinical manifestation differs depending on the stage of life. During adolescence she may exhibit irregular menstruation, acne, hirsutism, or alopecia. During her reproductive years, she may present with obesity, acanthosis nigricans, infertility, or problems related to long-term PCOS sequelae, such as gynecological cancer, diabetes, or cardiovascular risk. (2,3)
PURPOSE OF THE STUDY-
Homoeopathy being holistic science, have immense scope in such complex endocrine disorder. Homoeopathy is known for its individualistic approach and holistic management of disease. The management of patient with Polycystic Ovary Syndrome will depend on the patient’s presenting complaints. As this complex entity presents with varied symptomatology this Holistic treatment modality can offer personalised treatment to every patient with polycystic ovary syndrome, hence it is an attempt to determine effectiveness of Individualised Homoeopathic medicines in management of Polycystic Ovary Syndrome among females of reproductive age group. Most of the studies were conducted either on single patient or small group of patients, to validate the result of small group studies, this larger sample size study is preferred.
AIM: To study effectiveness of homoeopathy in polycystic ovary syndrome among female of reproductive age
PRIMARY OBJECTIVES: To determine the effectiveness of Individualised Homoeopathic Medicines in management of Polycystic Ovary Syndrome among females of reproductive age.
SECONDARY OBJECTIVES: To determine effectiveness of Individualised Homoeopathic Medicine in improving USG findings in Polycystic Ovary Syndrome among females of reproductive age.
OTHER OBJECTIVES-
1. Review of polycystic ovary syndrome.
2. Review of homoeopathic Materia Medica for polycystic ovary syndrome.
3 To observe the menstrual cycle changes after medicinal intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- •clinical or biochemical hyperandrogenism evidence of oligomenorrhoea or anovulation ultrasonography findings of follicles with polycystic appearing in ovarian morphology.
排除标准
- •diagnosed cases of other endocrinal disorders.
结局指标
主要结局
USG changes and symptomatic relief in polycystic ovary syndrome cases
时间窗: 1 year
次要结局
- menstrual regularity, reduced acne and hirsutism(1 year)
研究者
Aparna Kulkarni
Dhondumama Sathe Homoeoepathic Meddical College
