Nutritional gummies in Pre Menstrual Syndrome

Safety and efficacy of Power gummies: That time of the month nutritional gummies in Pre Menstrual Syndrome-A multicentric randomized controlled clinical study. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037425

Enrollment

Registered

2021-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PMS Gummies: 2 Gummies a day- 3 days before due date of menstrual cycle, 4 days during cycle and after 3 days of cycle. A total of 10 days. Control Intervention1: CBT therapy: Counselli

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients age within the range of 18 to 40 years 2.Patients with regular/ irregular menstrual cycle with a cycle length of 21-35 days 3.Presenting with signs and symptoms of premenstrual syndrome. Any three of the following- Irritability Anxiety Breast tenderness Abdominal pain Headache Mood swings Hot flushes PMS related acne

Exclusion criteria

Exclusion criteria: 1.Patients on hormonal replacement therapy 2.Patients with known systemic and metabolic diseases in investigator discretion not proving fit for trial 3.Diagnosed cases of psychiatric disorder 4.Pregnant and lactating mothers

Design outcomes

Primary

Measure	Time frame
1.Changes in symptom grading on VAS scale (0-10) irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal pain, headache, gastric disturbances like bloating, constipation, body pain, hot flushes, night sweat, swelling of extremities ,acne etc. 2.Changes in premenstrual tension scale (PMTS) score. 3.Changes in quality of sleep questionnaire score.Timepoint: Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle.	—

Measure

Time frame

1.Changes in symptom grading on VAS scale (0-10) irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal pain, headache, gastric disturbances like bloating, constipation, body pain, hot flushes, night sweat, swelling of extremities ,acne etc. 2.Changes in premenstrual tension scale (PMTS) score. 3.Changes in quality of sleep questionnaire score.Timepoint: Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle.

—

Secondary

Measure	Time frame
1.Changes in perceived stress scale score. 2.Changes in antioxidant enzyme glutathione (GSH) levels. 3.Changes in complete blood count and serum iron levels. 4.Changes in score of Menstrual Regulation Behavior Questionnaire. Timepoint: Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle.	—

Countries

India

Contacts

Public ContactMr Kapil Mittal

Mprex Healthcare Pvt. Ltd.

gayatri.mbgindia@gmail.com8554912644

Outcome results