Homeopathic Treatment of Premenstrual Syndrome

Premenstrual Syndrome-PMS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02402049
• Other study ID #: PMS-14
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 12, 2015
• Last updated: March 24, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Shaare Zedek Medical Center
• Contact: Menachem Oberbaum, MD
• Phone: +972-2-6666395
• Email: oberbaum[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Premenstrual Syndrome-PMS
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 months	No
Secondary	Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.		3 months	No
Secondary	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	No
Secondary	Self-report of the efficiency of the homeopathy treatment.	The patient will indicate subjectivlly her filling after taking the homeopathic remedy	3 months	No
Secondary	Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)		3 months	No