NCT02402049

Homeopathic Treatment of Premenstrual Syndrome

Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Premenstrual Syndrome-PMS

Interventions

Type	Name	Description
DRUG	Natrum muriaticum 30C	3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Lachesis 30C	3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Sepia 30C	3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Nux vomica 30C	3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Pulsatilla 30C	3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Folliculinum 30C	3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Placebo Natrum muriaticum	3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Placebo Lachesis	3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Placebo Sepia	3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Placebo Nux vomica	3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Placebo pulsatilla	3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
DRUG	Placebo Folliculinum	3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-03-30
• Last updated: 2015-03-30