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Homeopathic Treatment of Premenstrual Syndrome

Primary Purpose

Premenstrual Syndrome-PMS

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Natrum muriaticum 30C
Lachesis 30C
Sepia 30C
Nux vomica 30C
Pulsatilla 30C
Folliculinum 30C
Placebo Natrum muriaticum
Placebo Lachesis
Placebo Sepia
Placebo Nux vomica
Placebo pulsatilla
Placebo Folliculinum
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome-PMS

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    1: Natrum muriaticum 30C

    2: Lachesis 30C

    3: Sepia 30C

    4: Nux vomica 30C

    5: Pulsatilla 30C

    6 Folliculinum 30C

    1: Placebo Natrum muriaticum

    2: Placebo Lachesis

    3: Placebo Sepia

    4: Placebo Nux vomica

    5: Placebo pulsatilla

    6: Placebo Folliculinum

    Arm Description

    Natrum muriaticum 30C

    Lachesis 30C

    Sepia 30C

    Nux vomica 30C

    Pulsatilla 30C

    Folliculinum 30C

    Placebo Natrum muriaticum

    Placebo Lachesis

    Placebo Sepia

    Placebo Nux vomica

    Placebo pulsatilla

    Placebo Folliculinum

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.
    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.
    Self-report of the efficiency of the homeopathy treatment.
    The patient will indicate subjectivlly her filling after taking the homeopathic remedy
    Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)

    Full Information

    First Posted
    March 12, 2015
    Last Updated
    March 24, 2015
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02402049
    Brief Title
    Homeopathic Treatment of Premenstrual Syndrome
    Official Title
    Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Syndrome-PMS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1: Natrum muriaticum 30C
    Arm Type
    Active Comparator
    Arm Description
    Natrum muriaticum 30C
    Arm Title
    2: Lachesis 30C
    Arm Type
    Active Comparator
    Arm Description
    Lachesis 30C
    Arm Title
    3: Sepia 30C
    Arm Type
    Active Comparator
    Arm Description
    Sepia 30C
    Arm Title
    4: Nux vomica 30C
    Arm Type
    Active Comparator
    Arm Description
    Nux vomica 30C
    Arm Title
    5: Pulsatilla 30C
    Arm Type
    Active Comparator
    Arm Description
    Pulsatilla 30C
    Arm Title
    6 Folliculinum 30C
    Arm Type
    Active Comparator
    Arm Description
    Folliculinum 30C
    Arm Title
    1: Placebo Natrum muriaticum
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Natrum muriaticum
    Arm Title
    2: Placebo Lachesis
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Lachesis
    Arm Title
    3: Placebo Sepia
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Sepia
    Arm Title
    4: Placebo Nux vomica
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Nux vomica
    Arm Title
    5: Placebo pulsatilla
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo pulsatilla
    Arm Title
    6: Placebo Folliculinum
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Folliculinum
    Intervention Type
    Drug
    Intervention Name(s)
    Natrum muriaticum 30C
    Other Intervention Name(s)
    Active Natrum muriaticum
    Intervention Description
    3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Lachesis 30C
    Other Intervention Name(s)
    Active Lachesis
    Intervention Description
    3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Sepia 30C
    Other Intervention Name(s)
    Active Sepia
    Intervention Description
    3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Nux vomica 30C
    Other Intervention Name(s)
    Active Nux vomica
    Intervention Description
    3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Pulsatilla 30C
    Other Intervention Name(s)
    Active Pulsatilla
    Intervention Description
    3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Folliculinum 30C
    Other Intervention Name(s)
    Active Folliculinum
    Intervention Description
    3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Natrum muriaticum
    Intervention Description
    3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Lachesis
    Intervention Description
    3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Sepia
    Intervention Description
    3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Nux vomica
    Intervention Description
    3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo pulsatilla
    Intervention Description
    3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Folliculinum
    Intervention Description
    3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.
    Time Frame
    3 months
    Title
    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
    Title
    Self-report of the efficiency of the homeopathy treatment.
    Description
    The patient will indicate subjectivlly her filling after taking the homeopathic remedy
    Time Frame
    3 months
    Title
    Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Menachem Oberbaum, MD
    Phone
    +972-2-6666395
    Email
    oberbaum@szmc.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Menachem Oberbaum, MD
    Organizational Affiliation
    The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Homeopathic Treatment of Premenstrual Syndrome

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