Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 主要终点
- Decrease in the average DRSP questionnaire scores during the 12 days prior to menstruation during three months following single dose homeopathy treatment as compared to the average DRSP questionnaire scores during the 12 days prior to menstruation during
研究概览
简要总结
The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire.
The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.
详细描述
Premenstrual syndrome (PMS) is a set of physical, emotional and behavioral symptoms that occur during the week preceding menstruation and which alleviate when the menstrual flow begins. PMS affects millions of women during their reproductive years. Mild symptoms, which usually do not interfere with daily activities, are experienced occasionally by almost all ovulatory women. Between 8-30% of ovulatory women suffer from moderate to severe PMS symptoms, which may even require treatment. The more severe form of PMS, premenstrual dysphoric disorder is considered to affect up to 8% of ovulatory women. This severe form is associated with severe disruptions in work function, family, or social relationships. To date, therapeutic interventions are insufficient and ranges from stress reduction and lifestyle changing to hormonal therapies and the use of psychotropic medications. While traditional medications do not necessarily offer satisfactory alleviation of PMS symptoms homeopathy can offer a significant alleviation of PMS symptoms for an extended period of time.
The proposed study will focus on PMS symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire.
Five Homeopathic remedies (Natrum muriaticum, Lachesis, Sepia, Nux vomica and Pulsatilla ) will be used, in five different therapy groups. The women will be allocated to the groups according to their matching to the remedy according to Homeopathic principles. In each group the women will either be treated with the appropriate remedy or with a placebo remedy. Women who do not match any of these five groups will be allocated to a sixth group receiving either Folliculinum that is given as general indication for PMS in homeopathy or placebo.
The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire at (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years.
- •Suffers from the PMS, confirmed by the DRSP questionnaire, for at least one year
- •Read and write in
- •Signing the informed consent form
排除标准
- •Comorbidity.
- •Use of medications.
- •Menstruation complains which do not correlate to the menstruation cycle.
- •Inability to be in a daily contact with the experiment center (e.g., by phone, electronically).
- •Participating in another clinical trial in the last 30 days.
研究组 & 干预措施
3: Placebo Sepia
Placebo Sepia
干预措施: Placebo Sepia (Drug)
1: Natrum muriaticum 30C
Natrum muriaticum 30C
干预措施: Natrum muriaticum 30C (Drug)
2: Lachesis 30C
Lachesis 30C
干预措施: Lachesis 30C (Drug)
3: Sepia 30C
Sepia 30C
干预措施: Sepia 30C (Drug)
4: Nux vomica 30C
Nux vomica 30C
干预措施: Nux vomica 30C (Drug)
5: Pulsatilla 30C
Pulsatilla 30C
干预措施: Pulsatilla 30C (Drug)
6 Folliculinum 30C
Folliculinum 30C
干预措施: Folliculinum 30C (Drug)
1: Placebo Natrum muriaticum
Placebo Natrum muriaticum
干预措施: Placebo Natrum muriaticum (Drug)
2: Placebo Lachesis
Placebo Lachesis
干预措施: Placebo Lachesis (Drug)
4: Placebo Nux vomica
Placebo Nux vomica
干预措施: Placebo Nux vomica (Drug)
5: Placebo pulsatilla
Placebo pulsatilla
干预措施: Placebo pulsatilla (Drug)
6: Placebo Folliculinum
Placebo Folliculinum
干预措施: Placebo Folliculinum (Drug)
结局指标
主要结局
Decrease in the average DRSP questionnaire scores during the 12 days prior to menstruation during three months following single dose homeopathy treatment as compared to the average DRSP questionnaire scores during the 12 days prior to menstruation during
时间窗: 3 months
次要结局
- Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)(3 months)
- Self-report of the efficiency of the homeopathy treatment.(3 months)
- Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.(3 months)
- Change in the amount of painkillers taken by the patient during the 3 months after homeopathy treatment as compared to the amount of medications taken by the patient during 2 months prior to therapy begin.(3 months)