A double blind, randomized, placebo-controlled pilot trial of individualized homeopathic medicines in heavy menstrual bleeding
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pictorial blood assessment chart (PBAC) score
研究概览
简要总结
Heavy menstrual bleeding (HMB)is a common gynecological that adversely affects quality of life and workproductivity. Approximately 10-35%of women report heavy menstrual periodsat some stage during their reproductive years, with 5% consulting a medical practitionerfor investigation of HMB. In research, HMB is defined as a measured menstrualblood loss of more than 80mL per cycle, but studies have repeatedly that atleast 40% of women seeking medical attention for heavy periods lose less thanthis volume. Homeopathy as a therapeutic system may offer significant benefitto patients suffering from HMB; however, the research evidence remainscompromised. In this double-blind, randomized, placebo-controlled pilot trialof individualized homeopathic medicines in treatment of HMB at D N DeHomoeopathic Medical College & Hospital, 60 females will be randomized toreceive either homeopathic medicines or identical-looking placebo for a periodof 3 months. PBAC and MMAS scores will be assessed at baseline and at the endof each menstrual cycle up to 3 cycles as the primary and secondary outcomemeasures respectively. Comparative analysis will be carried out after 3 monthsof intervention. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Heavy menstrual bleeding (HMB) as substantiated with a Pictorial blood assessment chart (PBAC) score of 100-185
- •Age: 18-45 years
- •Patients taking oral contraceptive pills will be considered for the study after giving a wash-out period of 1 month.
- •Patients giving written consent to participate in the study.
- •Literate patients, who can read and write in Bengali and/or English.
排除标准
- •Patients suffering from carcinoma of cervix, chronic tubo-ovarian mass, endometrial carcinoma.
- •Vulnerable population – unconscious, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
- •Blood haemoglobin level less than 7g/dl.
- •Patient under tobacco chewing and / or smoking, alcoholism and / or any other form(s) of substance abuse and /or dependence.
- •Self-reported immune-compromised state.
- •Undergoing homeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
Pictorial blood assessment chart (PBAC) score
时间窗: At baseline, and after each menstrual cycle up to 3 cycles
次要结局
- Menorrhagia multi-attribute quality-of-life scale (MMAS) score(At baseline, and after each menstrual cycle up to 3 cycles)