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
About this trial
This is an interventional treatment trial for Premenstrual Syndrome-PMS
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.
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
NCT ID
NCT02402049
First Posted
March 12, 2015
Last Updated
March 24, 2015
Sponsor
Shaare Zedek Medical Center
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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