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Clinical evaluation of Rajapravartani Vati in Painful Menstruation

A prospective community based study for the evaluation of Rajapravartani Vati in the Management of Primary Dysmenorrhoea

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035334
Enrollment
50
Registered
2021-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N944- Primary dysmenorrhea

Interventions

None listed

Sponsors

Central Council for Research in Ayurvedic Sciences CCRAS
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactCHRIS ANTONY

Regional Ayurveda Research Institute CCRAS Mandi Himachal Pradesh

chrisantony1@gmail.com7807773464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026