Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
None listed
Sponsors
Amrita School of Ayurveda
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesic effect of Trailokya Vijaya Vati Plus (Formulation femme) in Primary Dysmenorrhoea. Timepoint: fourth month of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assess the associated symptoms of Primary Dysmenorrhea using Verbal Menstrual Descriptive Scale (VDS) 2.To assess the Working ability, Location, Intensity, and Days of Pain during Dysmenorrhea using the WaLIDD Score 3.To evaluate the severity of Primary Dysmenorrhea using Verbal Menstrual Scale (VMS). 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). 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. 6.To assess the safety of Trailokya Vijaya Vati Plus (Formulation femme) on any adverse events encountered during the trial period. Timepoint: End of each cycles | — |
Countries
India
Contacts
Public ContactDr Sushma Naranappa Salethoor
Amrita School of Ayurveda
Outcome results
None listed