A clinical trial to compare the effect of Cognitive Behavioral Therapy with and without the oral administration of Brahmi tablet in the management of Pre-Menstrual Syndrome (PMS)

A double-blind randomized placebo-controlled clinical trial to compare the effect of Cognitive Behavioral Therapy with and without the oral administration of Brahmi tablet in the management of Pre-Menstrual Syndrome (PMS) - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081239

Enrollment

Registered

2025-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: N943- Premenstrual tension syndrome

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Participants from 18 to 24 years of age having regular menstruation with a menstrual interval of 25-35 days from the past 6 months. Scoring below 10 on the PHQ 9 depression scale. Diagnosed with moderate to severe PMS through Premenstrual Syndrome Screening Tool (PSST). The diagnosis confirmed with screening by DRSP scale for 2 menstrual cycles. Participants willing to participate.

Exclusion criteria

Exclusion criteria: Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus. Under medication for any psychological or psychiatric disorders. Any substance use. Current PMS/PMDD treatment. Known case of pelvic pathology. Planning to conceive during the study period. Hormonal therapy. No access to mobile phones and internet.

Design outcomes

Primary

Measure	Time frame
1. Reduction in severity of daily problems using the DRSP scale. 2. Improvement in quality of life using Q-LES-Q SF. Timepoint: 1. Virtual screening, visit 1, visit 2, and visit 3. 2. visit 1, visit 2, and visit 3.	—

Secondary

Measure	Time frame
Reduction in the disability to function during PMS-related menstruation using the SDS tool.Timepoint: Visit 1, visit 2, and visit 3.	—

Countries

India

Contacts

Public ContactDr Parvathy Unnikrishnan

Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Kollam kerala

parvathyunnikrishnannair@gmail.com9497882774

Outcome results