Homeopathic Treatment of Premenstrual Syndrome

NCT ID: NCT02402049

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

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.

Conditions

Premenstrual Syndrome-PMS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1: Natrum muriaticum 30C

Natrum muriaticum 30C

Group Type: ACTIVE_COMPARATOR

Natrum muriaticum 30C

Intervention Type: DRUG

3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.

2: Lachesis 30C

Lachesis 30C

Group Type: ACTIVE_COMPARATOR

Lachesis 30C

Intervention Type: DRUG

3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.

3: Sepia 30C

Sepia 30C

Group Type: ACTIVE_COMPARATOR

Sepia 30C

Intervention Type: DRUG

3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.

4: Nux vomica 30C

Nux vomica 30C

Group Type: ACTIVE_COMPARATOR

Nux vomica 30C

Intervention Type: DRUG

3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.

5: Pulsatilla 30C

Pulsatilla 30C

Group Type: ACTIVE_COMPARATOR

Pulsatilla 30C

Intervention Type: DRUG

3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.

6 Folliculinum 30C

Folliculinum 30C

Group Type: ACTIVE_COMPARATOR

Folliculinum 30C

Intervention Type: DRUG

3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.

1: Placebo Natrum muriaticum

Placebo Natrum muriaticum

Group Type: PLACEBO_COMPARATOR

Placebo Natrum muriaticum

Intervention Type: DRUG

3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.

2: Placebo Lachesis

Placebo Lachesis

Group Type: PLACEBO_COMPARATOR

Placebo Lachesis

Intervention Type: DRUG

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

3: Placebo Sepia

Placebo Sepia

Group Type: PLACEBO_COMPARATOR

Placebo Sepia

Intervention Type: DRUG

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

4: Placebo Nux vomica

Placebo Nux vomica

Group Type: PLACEBO_COMPARATOR

Placebo Nux vomica

Intervention Type: DRUG

3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period.

5: Placebo pulsatilla

Placebo pulsatilla

Group Type: PLACEBO_COMPARATOR

Placebo pulsatilla

Intervention Type: DRUG

3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.

6: Placebo Folliculinum

Placebo Folliculinum

Group Type: PLACEBO_COMPARATOR

Placebo Folliculinum

Intervention Type: DRUG

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

Interventions

Natrum muriaticum 30C

3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: DRUG

Lachesis 30C

3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: DRUG

Sepia 30C

3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: DRUG

Nux vomica 30C

3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: DRUG

Pulsatilla 30C

3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: DRUG

Folliculinum 30C

3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: 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.

Intervention Type: DRUG

Placebo Lachesis

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

Intervention Type: DRUG

Placebo Sepia

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

Intervention Type: 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.

Intervention Type: DRUG

Placebo pulsatilla

3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.

Intervention Type: DRUG

Placebo Folliculinum

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

Intervention Type: DRUG

Other Intervention Names

Active Natrum muriaticum; Active Lachesis; Active Sepia; Active Nux vomica; Active Pulsatilla; Active Folliculinum

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Menachem Oberbaum, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel

Central Contacts

Menachem Oberbaum, MD

Role: CONTACT

oberbaum@szmc.org.il

+972-2-6666395

Other Identifiers

PMS-14

Identifier Type: -

Identifier Source: org_study_id