Clinical evaluation of Rajapravartani Vati in Painful Menstruatio

Phase 3

Conditions: Health Condition 1: N944- Primary dysmenorrhea

Registration Number: CTRI/2021/08/035334

Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i.Young women of age 18 -25 years of scheduled Caste community

ii.Self-reported history consistent with primary dysmenorrheal of moderate to severe nature (Mild: doesnâ??t interfere in normal activities, Moderate: slightly interferes in daily routines but can be managed by painkillers, Severe: markedly prevents daily life activities) with a self-reported menstrual cycle of averaging 21-35 days.

iii.Willing and able to participate in the study (Written informed consent or assent).

Exclusion Criteria

i.Irregular Cycles.

ii.Cases of secondary Dysmenorrhea

iii.Pain abdomen associated with excessive bleeding per vagina.

iv.Presence of persistent pelvic pain throughout the menstrual cycle.

v.Known case / diagnosis /h/o of leiomyoma of uterus, ovarian cyst, endometriosis.

vi.Associated with clinically diagnosed pelvic inflammatory disease (PID),

vii.Associated with any pre-diagnosed or clinically diagnosed systemic disorders likely to influence menstrual cycle.

viii.Patients with Hb <= 7 gm %

ix.History of malignancy of pelvic organs.

x.Diagnosed cases Hypo/hyperthyroidism.

xi.Woman using IUD / Oral Contraceptive Pills (OCP)

xii.Patient co morbid with systemic diseases like diabetes mellitus, hypertension, cardiac/ Renal/ Pulmonary/ Hepatic disorders.

xiii.Women who are planning to conceive in the next 6 months.

xiv.Participation in other concomitant therapy for acute or chronic pain.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i.Change in Visual Analog Scale (VAS) for pain.Timepoint: At baseline, after 1 month, after 2 months, after 3 months and after 4 months.

Secondary Outcome Measures

Name	Time	Method
i.Changes in total WaLLID score. <br/ ><br>ii.Change in Hb status of the subject from the baseline to the end of trial -12 weeks. <br/ ><br>iii.Decrease in the use of Analgesic medication (dosage & frequency of medication used) <br/ ><br>Timepoint: [Time Frame: Assessed via questionnaire after every menstrual cycle for four cycles]