Effectiveness of Constitutional Homoeopathic Treatment in Managing Pre-Menstrual Syndrome -A Clinical Study
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1.Effectiveness of Constitutional Homoeopathic Treatment in reducing Pre-Menstrual Syndrome Symptoms
Study Overview
Brief Summary
A Psychoneuroendocrine disorder of unknown etiology, Premenstrual syndrome (PMS) is characterized by the cyclical occurrence of several symptoms in the final seven to ten days of the menstrual cycle. According to the American College of Obstetricians and Gynecologists’ (ACOG) criteria, it is diagnosed as Pre-Menstrual Syndrome (PMS) when symptoms significantly interfere with day-to-day functioning. About 47.8% of women of reproductive age worldwide suffer from Pre-Menstrual Syndrome. Another known risk factor for postpartum depression is Pre-Menstrual Syndrome. Hormonal changes, stress, diet, and neurotransmitter imbalances—especially those involving aberrant serotonin activity and altered neurosteroid metabolism—are all contributing factors. However, women with and without PMS may have the same absolute hormone levels. The severity of PMS varies from person to person; 30.6% report mild symptoms, 13.6% report moderate symptoms, and 8.1% report severe distress. Women with regular cycles tend to report more symptoms than those with irregular periods. Even though PMS is very common and has a big influence on public health, the Global Burden of Disease (GBD) model predicts that each woman with severe PMS will be disabled for about 3.835 years. Despite the use of vitamin/mineral supplements (62%), exercise (59%), natural progesterone (51%), dietary changes (44%), antidepressants (15%), and anxiolytics (10%), only about one-third of women say they are satisfied with the treatments they have received. In light of these restrictions, the purpose of this clinical study is to assess how well constitutional homeopathic treatment can control Pre-Menstrual Syndrome and enhance quality of life. Pre-Menstrual Syndrome symptoms, each patient’s mental, emotional, and physical constitution will be examined. Based on the sum of their symptoms, a suitable homeopathic remedy will be selected and medications will be given on Day 18 of the typical 28-day cycle, calculated based on longer and shorter cycles accordingly. The Premenstrual Syndrome Assessment Scale (PMSS) will be used to evaluate progress every month to assess the reduction in the Pre-Menstrual Symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 12.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Aged 12 to 40 years Nulliparous women Premenstrual Syndrome diagnosed based on American College of Obstetricians and Gynecologists diagnostic criteria.
- •Symptoms should be cyclical, occurring in the luteal phase 5 to 10 days before menstruation and resolving within 4 days of menstrual onset for at least three consecutive menstrual cycles.
- •Regular menstrual cycles 21 to 35 day Presence of at least one affective symptom and one somatic symptom.
Exclusion Criteria
- •Women above 40 years Irregular menstrual cycle Symptoms that persist beyond menstruation or occur inconsistently, indicating non cyclic mood disorders Diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder, or any other psychiatric illness requiring pharmacological intervention.
- •Current or recent use within the past three months of hormonal therapy oral contraceptives, hormone replacement therapy or selective serotonin reuptake inhibitors for Pre Menstrual Syndrome.
- •Nulliparous women with signs of perimenopause, such as hot flashes, night sweats, vaginal dryness, or persistent cycle irregularities.
- •Presence of gynecological conditions that could mimic Pre Menstrual Syndrome, including endometriosis, adenomyosis, chronic pelvic inflammatory disease, or ovarian cysts.
Outcomes
Primary Outcomes
1.Effectiveness of Constitutional Homoeopathic Treatment in reducing Pre-Menstrual Syndrome Symptoms
Time Frame: 6 Months
Secondary Outcomes
- 1.Improvement in Quality of Life in Pre-Menstrual Syndrome cases(2.Reduction in the need for Conventional Medications)
Investigators
Dr AMRITHA K
Sarada Krishna Homoeopathic Medical College and Hospital