Role Of Individualized Homoeopathic Medicine In Post Menopausal Genitourinary Syndrome By Using Synthesis Repertory: An Open Label Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Vulvovaginal Symptom Questionnaire (VSQ21)
研究概览
简要总结
Genitourinary syndrome of menopause (GSM), formerly called vulvovaginal atrophy, atrophic vaginitis or urogenital atrophy, is a chronic condition that affects the vulvovaginal area, sexual function, and lower urinary tract. GSM includes a spectrum of symptoms that affect both the genital and urinary systems, manifesting as vaginal dryness, irritation, dyspareunia (pain during intercourse), urinary incontinence, and recurrent urinary tract infections.
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Samples will be selected following preliminary and detailed screening using specified selection criteria.
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Inclusion and exclusion criteria are strictly followed.
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After consideration of dropout cases, a minimum 40 patients will be enrolled for the study.
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Case-taking will be done as per the strict homoeopathic principle.
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Baseline scoring will be taken using VSQ21.
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Analysis and evaluation of each case will be done.
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Miasmatic analysis will be done.
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Repertorization will be done in Synthesis Repertory.
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Final selection of the remedy will be done after consultation with Materia Medica.
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Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles.
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General (non-medicinal) management including appropriate diet and regimen will be advised.
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Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets.
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The baseline data will be compared with the data obtained after 6 months.
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The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter.
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
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients between 40-60 years of age having natural menopause with 12 months of amenorrhea, clinically diagnosed with Genitourinary Syndrome of Menopause using the Vulvovaginal Symptom Questionnaire (VSQ).
- •Female patients of all socio-economic status and all religions.
- •Willingness to actively participate in the study, attend regular follow-up assessments, and adhere to the prescribed homeopathic treatment plan.
- •Patients who can read/understand Hindi, English, or Bengali.
- •Female patients with known but controlled systemic diseases.
- •Stable overall health without acute or severe medical conditions.
排除标准
- •Female Patients who have undergone Hysterectomy.
- •Female patients who are having malignant diseases
- •Female patients using any medicine or hormone therapy containing oestrogen and progesterone since 3months.
- •Female patients suffering from any life threatening/ psychiatric illness or immune compromised state.
- •Female patients who are on substance abuse or dependence.
- •Dermatological conditions of vulva such as lichen sclerosus or planus, eczema, dermatitis; Vulvodynia; Vaginosis; Chronic vulvovaginitis.
- •Inability or unwillingness to comply with scheduled follow-up visits and assessments.
结局指标
主要结局
Vulvovaginal Symptom Questionnaire (VSQ21)
时间窗: Baseline & 6 months
次要结局
- Socio-demographic data(After 6 months)
研究者
Dr Bobbili Lakshmi Mounica
National Institute Of Homoeopathy