Premenstrual Syndrome-PMS Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06289764 -
The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS
|
N/A |