Efficacy of individualized homoeopathic medicines in the treatment of heavy menstrual bleeding of reproductive females: A Double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pictorial Blood Loss Assessment Chart (PBAC)
研究概览
简要总结
Heavy menstrual bleeding is a common gynecological complaint that is characterised by excessive menstrual blood loss > 80ml which interferes with the women’s physical, emotional, social and psychological quality of life. In 2024 estimated that during the reproductive years, it affects about 1 in 5 women. Heavy menstrual bleeding is the leading cause of iron deficiency anemia. Throughout the reproductive years, 10-35% of women report having profuse bleeding and 5% seek medical attention. Previous studies suggests potential benefits of individualized homoeopathic treatments in managing different gynecological chronic conditions but rigorous evidence supporting its efficacy in HMB is limited. This study aims to evaluate the efficacy and to fill the gap in scientific research on the use of IHMs for heavy menstruation. A double-blind, randomized, placebo-controlled trial will be conducted on 66 reproductive females suffering from heavy menstrual bleeding at the outpatients of D.N. De Homoeopathic Medical College and Hospital. The primary outcome measure is PBAC score; the secondary outcomes are MBQ, and MYMOP-2 questionnaires, all are measured at baseline, and every cycle, up tp 6 consecutive menstrual cycles. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age- reproductive females between 13 and 40 years.
- •2.Patients of mild and moderate cases of heavy menstrual bleeding assessed by PBAC score between 100 and
- •3.Participants who can clearly understand and fill the Pictorial blood loss assessment chart questionnaires.
排除标准
- •Failing to give written, informed consent or assent before participating.
- •Cases of Malignancy (M), Coagulopathy (C), Ovulatory cause (O), Iatrogenic (I), Not otherwise classified (N) as per Figo classification of PALM-COEIN.
- •Hemoglobin less than 7 gm /dl.
- •Suffering from any uncontrolled systemic diseases like diabetes, hypertension, thyroid disorders, etc.
- •Women having leiomyoma size of 5 cm or more.
- •Women who are planning for child within 1 year.
- •Patient undergoing any hormonal replacement therapy, using contraceptive pills, intra uterine devices or history of their use in previous 3 months.
- •Those who are too ill to get consultation.
- •Diagnosed cases of uncontrolled or potentially fatal illnesses impacting quality of life, such as unstable mental or psychiatric illnesses.
- •Lactating mothers and women in puerperal states.
- •AIDS, hepatitis, and other self-reported immune weakened states.
- •Receiving homeopathic treatment within the last 3 months for any chronic illness.
- •Concurrent involvement in any other clinical study.
- •The requirement for further procedures in addition to surgery.
- •Chewing tobacco, smoking, alcoholism, any kind of substance addiction, abuse, and/or dependence (TAPS tool).
结局指标
主要结局
Pictorial Blood Loss Assessment Chart (PBAC)
时间窗: Baseline, 4 weeks, and 8 weeks
次要结局
- Menstrual Bleeding Questionnaires (MBQ)(Baseline, 4 weeks, & 8 weeks)
- Measure Yourself Medical Outcome Profile v-2 (MYMOP-2)(Baseline, 4 weeks, & 8 weeks)
研究者
Nargis Khatun
D N De Homoeopathic Medical College and Hospital