CTRI/2025/03/081600
Not yet recruiting
Not Applicable
The Impact of Probiotics in Relieving Symptoms of Primary Dysmenorrhea: A Randomized Single Blind Placebo Controlled Trial
Dr Neelu Bharti1 site in 1 country300 target enrollmentStarted: March 15, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Neelu Bharti
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Quality of life
Overview
Brief Summary
This study is aiming to evaluate the impact and effectiveness of oral probiotics 1capsule OD for 1 month to 3 months in relieving excessive pain during menses. The study is randomized single blind placebo-controlled trial. it shows beneficial effects of probiotics for reproductive age group females suffering from primary dysmenorrhea by reducing painkiller (NSAIDS) intake frequency during menses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female of age 15-35 years 2)Diagnosed with primary dysmenorrhea 3)Moderate to severe pain during menses on visual analogue scale 4)No H/O any other gynecological disoerder.
Exclusion Criteria
- •Pregnancy 2)Use of antibiotics within 3 Months prior to study 3)Current use of OCPs 4)Chronic gastrointestinal disorders.
Outcomes
Primary Outcomes
Quality of life
Time Frame: Baseline, 3 months, 6 months
Secondary Outcomes
- Adverse drug reaction of drugs(Every 3 months for 6 months)
Investigators
Dr Anil Kumar
BRD Medical College, Gorakhpur
Study Sites (1)
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