Efficacy of Rajapravartani Vati and Saraswatarishta in Dysmenorhoea

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i.Women of age 14 -25 years with self-reported history of menstrual pain of moderate to severe nature (as per WaLIDD score) (Annexure I)

ii.At least 3 painful cycles in last 6 cycles

iii.Having normal menstrual cycle (21-35 days) with normal menstrual bleeding (3-7 days) during last 3 cycles

iv.Participants willing to provide written informed consent/ assent for their participation in the study for 6 months.

Exclusion Criteria

i.Irregular Cycles.

ii.Cases of secondary Dysmenorrhea [Known case or h/o of leiomyoma of uterus, ovarian cyst, endometriosis. pelvic inflammatory disease (PID)]

iii.Pain abdomen associated with excessive bleeding per vagina.

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

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

vi.Participants with Hb <10 gm %

vii.History of malignancy of pelvic organs.

viii.Diagnosed cases Hypothyroidism /hyperthyroidism

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

x.Participants having blood pressure = 160/100 mmHg, &/or HbA1C >8 %

xi.Participants with concurrent serious hepatic disorder (defined as Aspartate AminoTransferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine > upper normal limit)

xii.Participants with diagnosed concurrent neurological, pulmonary or endocrine disorder, or unstable cardio-vascular disease

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

xiv.Lactating women

xv.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
Change in Visual Analog Scale (VAS) for pain ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain)Timepoint: At base line, at the end of 1st, 2nd 3rd, 4th, 5th and 6th cycle

Secondary Outcome Measures

Name	Time	Method
i.Change in disease specific symptom by means of total WaLLID score <br/ ><br>ii.Changes in the psychosomatic status of the study participants by using MOOS Menstrual Distress Questionnaire <br/ ><br>iii.Occurrence of treatment emergent adverse events during the study period <br/ ><br>iv.Use of Analgesic medication (dosage & frequency of medication used)Timepoint: i. At base line, at the end of 1st, 2nd 3rd, 4th, 5th & 6th cycle] <br/ ><br>ii. At base line and at the end of 3rd cycle <br/ ><br>iii. At baseline upto at the end of 3rd cycle <br/ ><br>iv. At base line, at the end of 1st, 2nd 3rd, 4th, 5th and 6th cycle