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Homeopathic Treatment of Premenstrual Syndrome

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ClinicalTrials.gov Identifier: NCT02402049
Recruitment Status : Unknown
Verified March 2015 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

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.


Condition or disease Intervention/treatment Phase
Premenstrual Syndrome-PMS Drug: Natrum muriaticum 30C Drug: Lachesis 30C Drug: Sepia 30C Drug: Nux vomica 30C Drug: Pulsatilla 30C Drug: Folliculinum 30C Drug: Placebo Natrum muriaticum Drug: Placebo Lachesis Drug: Placebo Sepia Drug: Placebo Nux vomica Drug: Placebo pulsatilla Drug: Placebo Folliculinum Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1: Natrum muriaticum 30C
Natrum muriaticum 30C
Drug: Natrum muriaticum 30C
3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
Other Name: Active Natrum muriaticum

Active Comparator: 2: Lachesis 30C
Lachesis 30C
Drug: Lachesis 30C
3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.
Other Name: Active Lachesis

Active Comparator: 3: Sepia 30C
Sepia 30C
Drug: Sepia 30C
3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.
Other Name: Active Sepia

Active Comparator: 4: Nux vomica 30C
Nux vomica 30C
Drug: Nux vomica 30C
3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
Other Name: Active Nux vomica

Active Comparator: 5: Pulsatilla 30C
Pulsatilla 30C
Drug: Pulsatilla 30C
3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
Other Name: Active Pulsatilla

Active Comparator: 6 Folliculinum 30C
Folliculinum 30C
Drug: Folliculinum 30C
3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
Other Name: Active Folliculinum

Placebo Comparator: 1: Placebo Natrum muriaticum
Placebo Natrum muriaticum
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.

Placebo Comparator: 2: Placebo Lachesis
Placebo Lachesis
Drug: Placebo Lachesis
3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period.

Placebo Comparator: 3: Placebo Sepia
Placebo Sepia
Drug: Placebo Sepia
3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period.

Placebo Comparator: 4: Placebo Nux vomica
Placebo Nux vomica
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.

Placebo Comparator: 5: Placebo pulsatilla
Placebo pulsatilla
Drug: Placebo pulsatilla
3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.

Placebo Comparator: 6: Placebo Folliculinum
Placebo Folliculinum
Drug: Placebo Folliculinum
3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment. [ Time Frame: 3 months ]
  2. 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 ]
  3. 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

  4. Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402049


Contacts
Contact: Menachem Oberbaum, MD +972-2-6666395 oberbaum@szmc.org.il

Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, MD The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02402049     History of Changes
Other Study ID Numbers: PMS-14
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances