Homeopathic Treatment of Premenstrual Syndrome

NCT02402049 | Unknown Phase 3

• 1 other identifier: PMS-14
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premenstrual Syndrome-PMS

Outcome Measures

Primary Outcomes (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

  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.

  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.

  3 months

• Self-report of the efficiency of the homeopathy treatment.

  3 months

• Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)

  3 months

Study Arms (12)

1: Natrum muriaticum 30C

ACTIVE COMPARATOR

Natrum muriaticum 30C

Drug: Natrum muriaticum 30C

2: Lachesis 30C

ACTIVE COMPARATOR

Lachesis 30C

Drug: Lachesis 30C

3: Sepia 30C

ACTIVE COMPARATOR

Sepia 30C

Drug: Sepia 30C

4: Nux vomica 30C

ACTIVE COMPARATOR

Nux vomica 30C

Drug: Nux vomica 30C

5: Pulsatilla 30C

ACTIVE COMPARATOR

Pulsatilla 30C

Drug: Pulsatilla 30C

6 Folliculinum 30C

ACTIVE COMPARATOR

Folliculinum 30C

Drug: Folliculinum 30C

1: Placebo Natrum muriaticum

PLACEBO COMPARATOR

Placebo Natrum muriaticum

Drug: Placebo Natrum muriaticum

2: Placebo Lachesis

PLACEBO COMPARATOR

Placebo Lachesis

Drug: Placebo Lachesis

3: Placebo Sepia

PLACEBO COMPARATOR

Placebo Sepia

Drug: Placebo Sepia

4: Placebo Nux vomica

PLACEBO COMPARATOR

Placebo Nux vomica

Drug: Placebo Nux vomica

5: Placebo pulsatilla

PLACEBO COMPARATOR

Placebo pulsatilla

Drug: Placebo pulsatilla

6: Placebo Folliculinum

PLACEBO COMPARATOR

Placebo Folliculinum

Drug: Placebo Folliculinum

Interventions

Natrum muriaticum 30C DRUG

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

Also known as: Active Natrum muriaticum

1: Natrum muriaticum 30C

Lachesis 30C DRUG

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

Also known as: Active Lachesis

2: Lachesis 30C

Sepia 30C DRUG

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

Also known as: Active Sepia

3: Sepia 30C

Nux vomica 30C DRUG

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

Also known as: Active Nux vomica

4: Nux vomica 30C

Pulsatilla 30C DRUG

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

Also known as: Active Pulsatilla

5: Pulsatilla 30C

Folliculinum 30C DRUG

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

Also known as: Active Folliculinum

6 Folliculinum 30C

Placebo Natrum muriaticum DRUG

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

1: Placebo Natrum muriaticum

Placebo Lachesis DRUG

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

2: Placebo Lachesis

Placebo Sepia DRUG

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

3: Placebo Sepia

Placebo Nux vomica DRUG

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

4: Placebo Nux vomica

Placebo pulsatilla DRUG

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

5: Placebo pulsatilla

Placebo Folliculinum DRUG

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

6: Placebo Folliculinum

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Menachem Oberbaum, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menachem Oberbaum, MD

CONTACT

+972-2-6666395; oberbaum@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 30, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 30, 2015

Record last verified: 2015-03