Clinical Trial: Homeopathic Treatment of Premenstrual Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
Brief Summary:
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.
Detailed Summary:
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 u
Sponsor: Shaare Zedek Medical Center
Current Primary Outcome: 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 [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment. [ Time Frame: 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. [ Time Frame: 3 months ]
- Self-report of the efficiency of the homeopathy treatment. [ Time Frame: 3 months ]The patient will indicate subjectivlly her filling after taking the homeopathic remedy
- Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.) [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Shaare Zedek Medical Center
Dates:
Date Received: March 12, 2015
Date Started: March 2015
Date Completion: March 2016
Last Updated: March 24, 2015
Last Verified: March 2015
