A clinical study of analgesic effect of Trailokya Vijaya Vati Plus (Formulation femme) in menstrual pain.

Not Applicable

Conditions: Health Condition 1: N944- Primary dysmenorrhea

Registration Number: CTRI/2023/04/051304

Lead Sponsor: Amrita School of Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Subjects with regular menstrual periods lasting

21 to 35 days and menstruation lasting for 3 to

7 days.

2. Subjects who give consent for the study.

3. Other causes of pain excluded using USG.

4. Screened Subjects will be assessed by:Clinical

history and physical examination,

Haematological: Hb,ESR, CBC, Serum SGOT, SGPT &

Serum BUN and Creatinine within 1.5 times the

upper limit of normal range detected at

screening, Urine analysis and USG.

Exclusion Criteria

1. Subjects having Dysmenorrhea secondary to

organic pathologies

2. Subjects with irregular menstrual bleeding

3. Subjects having a severe gynaecological illness

like uterine pathology fibroid adenomyosis

endometriosis etc

4. Subjects with autoimmune diseases gynaecological Surgeries and genitourinary infections

5. Subjects under hormonal therapy

6. History or documentation of chronic illnesses

eg Diabetes hypertension Hypothyroidism bronchial asthma Gastroesophageal Reflux

Disease GERD atopic dermatitis celiac

disease or gluten sensitivity Crohns Disease

ulcerative colitis eating disorders breast

cancer a blood disorder

7. History of alcohol drug abuse or cigarette

smoking

8. Subjects participating in another investigational drug trial or had participated in one within 30 days of the start of the trial intervention

9. The subject participated in another investigational drug trial in the previous 30 days

10. Mentally retarded patients

11. Any other medical condition which in the

opinion of the investigator precludes the

inclusion of participant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analgesic effect of Trailokya Vijaya Vati Plus (Formulation femme) in Primary Dysmenorrhoea. <br/ ><br> <br/ ><br>Timepoint: fourth month of the study.

Secondary Outcome Measures

Name	Time	Method
<br/ ><br>1.Assess the associated symptoms of Primary Dysmenorrhea using Verbal Menstrual Descriptive Scale (VDS) <br/ ><br>2.To assess the Working ability, Location, Intensity, and Days of Pain during Dysmenorrhea using the WaLIDD Score <br/ ><br>3.To evaluate the severity of Primary Dysmenorrhea using Verbal Menstrual Scale (VMS). <br/ ><br>4.To assess the type of symptoms in physical, behavioural mood changes and arousal symptoms during different phases, the severity of pain of recruited subjects of Primary Dysmenorrhea using the Menstrual Distress Questionnaire (MDQ). <br/ ><br>5.To evaluate the safety of Trailokya Vijaya Vati Plus (Formulation femme) with respect to haematological parameters like Hb, ESR, CBC, SGOT, SGPT, BUN, S. Creatinine during 1st visit & Visit 5 Day 3 ± 2 days. <br/ ><br>6.To assess the safety of Trailokya Vijaya Vati Plus (Formulation femme) on any adverse events encountered during the trial period. <br/ ><br>Timepoint: End of each cycles