Painful menses

Phase 2

Not yet recruiting

Conditions: Primary dysmenorrhea,

Registration Number: CTRI/2020/02/023283

Lead Sponsor: National institute of unani medicine

Brief Summary: Dysmenorrhea is the most common gynecological problem among females and it is defined as painful menses which occur in the absence of any identifiable pelvic pathology. It is the leading cause of absenteeism from school,work,and reduced physical quality of life. Pain is the subjective symptom There is wide spectrum of clinical presentation comprising of colicky suprapubic pain, lumbo sacral backache radiating to anterior thighs, nausea, vomiting, diarrhoea, giddiness and tiredness. Intensity of pain is described as mild,moderate & severe.The aim of the present study is to evaluate & compare the effect of a Unani formulation & dry cupping in patients with primary dysmenorrhoea. Necessary laboratory investigations will be done during the study period. Research drug will be given orally in sharbat form twice daily for 7 days/cycle for 3 consecutive cycles. Dry cupping will be applied below the umbilicus for 15 minutes/cycle on every alternate day during menses (total 3 sittings). Assessment will be done before & after period for 3 consecutive cycles during treatment & once in a month for 1 month after treatment. It is assumed that research drug & dry cupping may be useful to relief menstrual pain in patients with primary dysmenorrhoea.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 40

Inclusion Criteria

1-patients in age group of 15-35 yrs with regular menstrual cycle (21-35 days) having moderate to severe painful menses 2-VAS score of 4-10 and VMS of grade 2-3 and primary dysmenorrhoea accompanied with nausea, vomiting, dizziness, headache, diarrhea and tiredness.

Exclusion Criteria

1-secondary dysmenorrhoea 2-Organic pelvic pathology (Pelvic inflammatory disease, uterine fibroids, endometriosis, adenomyosis, adnexal masses, endometrial polyp) 3-H/o use of OCPâ€™s or IUCD, abdominal & pelvic surgery 4-Systemic illness (Hypertension, & Diabetes mellitus), H/o urinary tract infection, Irritable bowel syndrome, Acid peptic disease, skin diseases.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in menstrual pain	Monthly for 3 months

Secondary Outcome Measures

Name	Time	Method
Reduction in VAS and VMS score	Monthly for 3 months

Trial Locations

Locations (1): National instutute of unani medicine.
🇮🇳
Bangalore, KARNATAKA, India
National instutute of unani medicine.
🇮🇳Bangalore, KARNATAKA, India
Farha Naz
Principal investigator
7417627637
farhanazamu4@gmail.com