Homeopathic Treatment of Premenstrual Syndrome

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 3

Conditions: Premenstrual Syndrome-PMS

Treatments: Drug: Placebo Folliculinum; Drug: Natrum muriaticum 30C; Drug: Lachesis 30C; Drug: Placebo Sepia; Drug: Sepia 30C; Drug: Placebo Nux vomica; Drug: Nux vomica 30C; Drug: Pulsatilla 30C; Drug: Placebo pulsatilla; Drug: Placebo Lachesis; Drug: Folliculinum 30C; Drug: Placebo Natrum muriaticum

Study type: Interventional

Funder types: Other

Identifiers

NCT02402049

PMS-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 12 patient groups, including a placebo group

1: Natrum muriaticum 30C

Active Comparator group

Description:

Natrum muriaticum 30C

Treatment:

Drug: Natrum muriaticum 30C

2: Lachesis 30C

Active Comparator group

Description:

Lachesis 30C

Treatment:

Drug: Lachesis 30C

3: Sepia 30C

Active Comparator group

Description:

Sepia 30C

Treatment:

Drug: Sepia 30C

4: Nux vomica 30C

Active Comparator group

Description:

Nux vomica 30C

Treatment:

Drug: Nux vomica 30C

5: Pulsatilla 30C

Active Comparator group

Description:

Pulsatilla 30C

Treatment:

Drug: Pulsatilla 30C

6 Folliculinum 30C

Active Comparator group

Description:

Folliculinum 30C

Treatment:

Drug: Folliculinum 30C

1: Placebo Natrum muriaticum

Placebo Comparator group

Description:

Placebo Natrum muriaticum

Treatment:

Drug: Placebo Natrum muriaticum

2: Placebo Lachesis

Placebo Comparator group

Description:

Placebo Lachesis

Treatment:

Drug: Placebo Lachesis

3: Placebo Sepia

Placebo Comparator group

Description:

Placebo Sepia

Treatment:

Drug: Placebo Sepia

4: Placebo Nux vomica

Placebo Comparator group

Description:

Placebo Nux vomica

Treatment:

Drug: Placebo Nux vomica

5: Placebo pulsatilla

Placebo Comparator group

Description:

Placebo pulsatilla

Treatment:

Drug: Placebo pulsatilla

6: Placebo Folliculinum

Placebo Comparator group

Description:

Placebo Folliculinum

Treatment:

Drug: Placebo Folliculinum