Role of the individualised homoeopathic medicine using 50 Millesimal potency in improving the quality of life of women with secondary infertility an open label non randomised clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The Fertility Quality of Life (FertiQoL) questionnaire.FertiQoL assesses the influences of fertility problems in diverse life areas.on general health, self-perceptions, emotions, partnership, family and social relationships, work life and future life plans. Additionally the optional FertiQoL Treatment module assesses the environment and tolerability of fertility treatment. It is hoped that FertiQoL will become the gold standard in measuring quality of life in people with fertility problems.36 FertiQoL items are rated according to 5 types of response scales.The response scales are: Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied.
研究概览
简要总结
This prospective open-label,non randomised ,clinical study will be conducted over 18 months at the NationalInstitute of Homoeopathy, Kolkata, with each patient followed for six months.The study aims to evaluate the effectiveness of individualized homoeopathictreatment in improving the quality of life of women with secondary infertility. The primary objective is to estimatethe changes in Fertility quality of life of women in secondary infertility usingindividualised Homoeopathy medicine in 50 millesimal potency. Adults aged 18-45years and patient diagnosed with secondary infertility and who score between0-100 in fertility quality of life questionnaire (FertiQol), Patient who canread/understand either English, Hindi, Bengali. Patient who are willing toparticipate in study and giving written informed consent will be included. Patientwhose husband have an abnormal semen analysis, Patient who have never conceiveda pregnancy before, Patient who have already attained menopause, Patient who arepregnant ,lactating mother, taking OCPs or post hysterectomy, Patient who aretaking medications for any chronic diseases, Patient who are diagnosed withlife threatening diseases, systemic illness, immune –compromised states, psychiatricillness, and malignancy, Undergoing Homoeopathic treatment for any chronicdisease within last 6 months will be excluded. Individualized homeopathicremedies will be selected based on repertorization (Synthesis Repertory) andMateria Medica, following Hahnemannian principles, with monthly follow-ups forsix months to assess symptom changes. Treatment efficacy will be determined bycomparing pre- and post-treatment of fertility Quality of life questionaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient diagnosed with secondary infertility and who score between 0-100 in fertility quality of life questionnaire (FertiQol).
- •2.Female patient with reproductive age 18-
- •3.Patient who can read/understand either English,Hindi, Bengali.
- •4.Patient who are willing to participate in study and giving written informed consent.
排除标准
- •1.Patient whose husband have an abnormal semen analysis.
- •2.Patient who have never conceived a pregnancy before.
- •3.Patient who have already attained menopause.
- •4.Patient who are pregnant ,lactating mother, taking OCPs or post hysterectomy.
- •5.Patient who are taking medications for any chronic diseases.
- •6.Patient who are diagnosed with life threatening diseases, systemic illness, immune –compromised states, psychiatric illness, and malignancy.
- •7.Undergoing Homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
The Fertility Quality of Life (FertiQoL) questionnaire.FertiQoL assesses the influences of fertility problems in diverse life areas.on general health, self-perceptions, emotions, partnership, family and social relationships, work life and future life plans. Additionally the optional FertiQoL Treatment module assesses the environment and tolerability of fertility treatment. It is hoped that FertiQoL will become the gold standard in measuring quality of life in people with fertility problems.36 FertiQoL items are rated according to 5 types of response scales.The response scales are: Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied.
时间窗: At baseline and 6 months
次要结局
- Symptomatic relief of the patient can be assessed from the analysis of case records & follow up sheets of the patient(Ultrasonography plays a vital role in the evaluation diagnosis management of infertility in women It helps in evaluating the pathological findings)