Effectiveness of Non-hormonal Treatment on Moderate to Severe Premenstrual Syndrome

Haleema Sadia

Status: Completed

Conditions: Premenstrual Syndrome-PMS

Treatments: Other: Placebo; Dietary Supplement: vitamin D (cholecalciferol) supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07078708

101

Details and patient eligibility

About

A double-blind, randomised, placebo-controlled, parallel trial was conducted involving 100 females aged 18-40, all of whom presented with premenstrual syndrome at the Department of Gynecology and Obstetrics, Avicenna Medical College Hospital, Lahore, Pakistan. Participants were randomly assigned to two groups of equal size: One group received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium, whereas the comparison group was administered a placebo under the same conditions for 12 weeks. All the participants were examined on premenstrual syndrome with the Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire

Full description

A double-blind, randomised, placebo-controlled, parallel trial was conducted involving 100 females aged 18-40, all of whom presented with premenstrual syndrome at the Department of Gynecology and Obstetrics, Avicenna Medical College Hospital, Lahore, Pakistan. Participants were randomly assigned to two groups of equal size: One group received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium, whereas the comparison group was administered a placebo under the same conditions for 12 weeks. All the participants were examined on premenstrual syndrome with the Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants aged 18-40 years with moderate to severe PMS

Exclusion criteria

• Individuals exhibiting symptoms of malnutrition or requiring calcium+vitamin D supplementation.
• Individuals with systemic diseases such as sepsis, hemodynamic instability, or acute meningitis; diarrhoea.
• Individuals with known intolerance or sensitivity to calcium vitamin D or calcium vitamin D containing compounds.
• smokers, Individuals with exposure to stressful situations or a history of mental illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Participants taking calcium and Vitamin D

Experimental group

Description:

In this group participants received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium for 12 weeks. Participants symptoms were assessed at baseline, one month, three months, and six months following the commencement of the study.

Treatment:

Dietary Supplement: vitamin D (cholecalciferol) supplementation

Participants taking placebo

Placebo Comparator group

Description:

In this group participants received placebo for 12 weeks. Participants symptoms were assessed at baseline, one month, three months, and six months following the commencement of the study.

Treatment:

Other: Placebo