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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-11-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Premenstrual Syndrome-PMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Participants taking calcium and Vitamin D

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.

Group Type EXPERIMENTAL

vitamin D (cholecalciferol) supplementation

Intervention Type DIETARY_SUPPLEMENT

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 taking placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo was given for 12 weeks

Interventions

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vitamin D (cholecalciferol) supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo was given for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes