Efficacy of Rajapravartani Vati and Saraswatarishta in Dysmenorhoea

Effectiveness of Rajapravartani Vati and Saraswatarishta in Dysmenorhoea - A prospective community based study - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054617

Enrollment

460

Registered

2023-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: R398- Other symptoms and signs involvingthe genitourinary system

Interventions

None listed

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
i. Change in disease specific symptom by means of total WaLLID score ii. Changes in the psychosomatic status of the study participants by using MOOS Menstrual Distress Questionnaire iii. Occurrence of treatment emergent adverse events during the study period 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] ii. At base line and at the end of 3rd cycle iii. At baseline upto at the end of 3rd cycle iv. At base line, at the end of 1st, 2nd 3rd, 4th, 5th and 6th cycle	—

Measure

Time frame

i. Change in disease specific symptom by means of total WaLLID score ii. Changes in the psychosomatic status of the study participants by using MOOS Menstrual Distress Questionnaire iii. Occurrence of treatment emergent adverse events during the study period 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] ii. At base line and at the end of 3rd cycle iii. At baseline upto at the end of 3rd cycle iv. At base line, at the end of 1st, 2nd 3rd, 4th, 5th and 6th cycle

—

Countries

India

Contacts

Public ContactVd Priya Thakare

Regional Ayurveda Research Institute, Nagpur

ard123md@rediffmail.com9175418356

Outcome results