Premenstrual Syndrome-PMSPhase 3NCT02402049
Homeopathic Treatment of Premenstrual Syndrome
A Phase 3 study testing Natrum muriaticum 30C, Lachesis 30C and Sepia 30C in people with Premenstrual Syndrome-PMS, run by Shaare Zedek Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Premenstrual Syndrome-PMS
- What is being tested?
- Natrum muriaticum 30C, Lachesis 30C and Sepia 30C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Read the 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
- Being tested
- Natrum muriaticum 30C, Lachesis 30C, Sepia 30C, Nux vomica 30C, Pulsatilla 30C
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natrum muriaticum 30CDrug
Also called Active Natrum muriaticum
3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
Lachesis 30CDrug
Also called Active Lachesis
3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.
Sepia 30CDrug
Also called Active Sepia
3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.
Nux vomica 30CDrug
Also called Active Nux vomica
3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
Pulsatilla 30CDrug
Also called Active Pulsatilla
3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
Folliculinum 30CDrug
Also called Active Folliculinum
3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
Placebo Natrum muriaticumDrug
3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
Placebo LachesisDrug
3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period.
Placebo SepiaDrug
3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period.
Placebo Nux vomicaDrug
3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
Placebo pulsatillaDrug
3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
Placebo FolliculinumDrug
3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
| Study group | Role | What they receive |
|---|---|---|
| 1: Natrum muriaticum 30C | Active comparator | Natrum muriaticum 30C Receives: Drug: Natrum muriaticum 30C |
| 2: Lachesis 30C | Active comparator | Lachesis 30C Receives: Drug: Lachesis 30C |
| 3: Sepia 30C | Active comparator | Sepia 30C Receives: Drug: Sepia 30C |
| 4: Nux vomica 30C | Active comparator | Nux vomica 30C Receives: Drug: Nux vomica 30C |
| 5: Pulsatilla 30C | Active comparator | Pulsatilla 30C Receives: Drug: Pulsatilla 30C |
| 6 Folliculinum 30C | Active comparator | Folliculinum 30C Receives: Drug: Folliculinum 30C |
| 1: Placebo Natrum muriaticum | Placebo comparator | Placebo Natrum muriaticum Receives: Drug: Placebo Natrum muriaticum |
| 2: Placebo Lachesis | Placebo comparator | Placebo Lachesis Receives: Drug: Placebo Lachesis |
| 3: Placebo Sepia | Placebo comparator | Placebo Sepia Receives: Drug: Placebo Sepia |
| 4: Placebo Nux vomica | Placebo comparator | Placebo Nux vomica Receives: Drug: Placebo Nux vomica |
| 5: Placebo pulsatilla | Placebo comparator | Placebo pulsatilla Receives: Drug: Placebo pulsatilla |
| 6: Placebo Folliculinum | Placebo comparator | Placebo Folliculinum Receives: Drug: Placebo Folliculinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.
Measured: 3 months
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.
Measured: 3 months
Self-report of the efficiency of the homeopathy treatment.
The patient will indicate subjectivlly her filling after taking the homeopathic remedy
Measured: 3 months
Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Syndrome-PMSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Menachem Oberbaum, MD, Principal investigator, The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402049
- Sponsor's protocol ID
- PMS-14
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02402049
- Acronym / sponsor ID
- PMS-14
- Conditions
- Premenstrual Syndrome-PMS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 1: Natrum muriaticum 30C | Active comparator | Drug: Natrum muriaticum 30CNatrum muriaticum 30C |
| 2: Lachesis 30C | Active comparator | Drug: Lachesis 30CLachesis 30C |
| 3: Sepia 30C | Active comparator | Drug: Sepia 30CSepia 30C |
| 4: Nux vomica 30C | Active comparator | Drug: Nux vomica 30CNux vomica 30C |
| 5: Pulsatilla 30C | Active comparator | Drug: Pulsatilla 30CPulsatilla 30C |
| 6 Folliculinum 30C | Active comparator | Drug: Folliculinum 30CFolliculinum 30C |
| 1: Placebo Natrum muriaticum | Placebo comparator | Drug: Placebo Natrum muriaticumPlacebo Natrum muriaticum |
| 2: Placebo Lachesis | Placebo comparator | Drug: Placebo LachesisPlacebo Lachesis |
| 3: Placebo Sepia | Placebo comparator | Drug: Placebo SepiaPlacebo Sepia |
| 4: Placebo Nux vomica | Placebo comparator | Drug: Placebo Nux vomicaPlacebo Nux vomica |
| 5: Placebo pulsatilla | Placebo comparator | Drug: Placebo pulsatillaPlacebo pulsatilla |
| 6: Placebo Folliculinum | Placebo comparator | Drug: Placebo FolliculinumPlacebo Folliculinum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natrum muriaticum 30CAlso: Active Natrum muriaticum3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period. | Drug | 1: Natrum muriaticum 30C |
| Lachesis 30CAlso: Active Lachesis3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period. | Drug | 2: Lachesis 30C |
| Sepia 30CAlso: Active Sepia3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period. | Drug | 3: Sepia 30C |
| Nux vomica 30CAlso: Active Nux vomica3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period. | Drug | 4: Nux vomica 30C |
| Pulsatilla 30CAlso: Active Pulsatilla3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period. | Drug | 5: Pulsatilla 30C |
| Folliculinum 30CAlso: Active Folliculinum3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period. | Drug | 6 Folliculinum 30C |
| Placebo Natrum muriaticum3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period. | Drug | 1: Placebo Natrum muriaticum |
| Placebo Lachesis3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period. | Drug | 2: Placebo Lachesis |
| Placebo Sepia3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period. | Drug | 3: Placebo Sepia |
| Placebo Nux vomica3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period. | Drug | 4: Placebo Nux vomica |
| Placebo pulsatilla3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period. | Drug | 5: Placebo pulsatilla |
| Placebo Folliculinum3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period. | Drug | 6: Placebo Folliculinum |
Primary outcome
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
4 secondary outcomes
Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.
Time frame: 3 months
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
Self-report of the efficiency of the homeopathy treatment.
Time frame: 3 months
Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, MD principal investigator
The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Natrum muriaticum 30C, Lachesis 30C and Sepia 30C in people with Premenstrual Syndrome-PMS, run by Shaare Zedek Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menachem Oberbaum, MD (+972-2-6666395, oberbaum@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.