MedPath

Clinical assessment of Navauppu Mezhugu for Painful menstruation.

Phase 3
Not yet recruiting
Conditions
Dysmenorrhea, unspecified,
Registration Number
CTRI/2023/02/049786
Lead Sponsor
Dr Megganah
Brief Summary

**INTRODUCTION:**Gynaecologyis the medical practice which deals with the female reproductive system.Dysmenorrhoea is a frequent and misdiagnosed symptom affecting the quality oflife in women.   Every woman experiences at least a minimum level ofpain during menstruation in their life time. But Dysmenorrhoea is defined asthe severe and frequent menstrual cramps and pain during the menstrual period.Dysmenorrhoea is the painful periods that affects 16% to 91% of woman whichmakes embarrassing to get into social gathering & even engage in personallife. It is classified as primary and secondary dysmenorrhoea.The primarydysmenorrhoea is one where there is no identifiable pelvic pathology. Increasedprostaglandin secretion intensifies uterine contractions, causing symptoms likeCramping in the lower abdomen, Pain in the lower abdomen, Low back pain, Painradiating down the legs, Nausea, Vomiting, Diarrhoea and Fatigue. Due to thisthere is a need to study about the effectiveness of Nava Uppu Mezhugu, which isindicated for the management of Primary dysmenorrhoea. This study is to assessthe improvement in clinical symptoms of Primary dysmenorrhoea using WaLIDDscore, before and after treatment after the intake of trial medicine, Nava UppuMezhugu. **MATERIALS AND METHODS:** An open clinical trial will be conductedin OPD of Ayothidoss Pandithar Hospital, National Institue of Siddha, TambaramSanatorium, Chennai.  A total of 10 diagnosed patients of Aga SoothagaVali (Primary Dysmenorrhoea) within the age limit of 18 to 25 years who arewilling to participate in the study by signing the consent form will beenrolled based on the inclusion and exclusion criteria. The trial drug NavaUppu Mezhugu will be given to the patients in 3 days of menstruation for 3consecutive months. **RESULTS AND DISCUSSION:** The effectiveness of thetrial drug is measured by significance reduction in clinical symptom assessedby using WaLIDD score and the discussion will be done according to the results.**KEYWORDS:** Primary Dysmenorrhoea, Misdiagnosed symptom, Increasedprostaglandin, WaLIDD score

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
10
Inclusion Criteria
  • Women in the age group between 11 to 25 years Onset of pain within 6-12 hours after the onset of menses Nulliparous women Cramping or pain in the lower abdomen Pelvic pain Low back pain Pain spreading down the legs.
  • Patient willing to sign the informed consent.
Exclusion Criteria

Presence of any pelvic pathology such as chronic pelvic infection, pelvic endometriosis, adenomyosis, uterine fibroid and endometrial polyp Presence of any associated severe systemic illness Uterine or cervical polyp.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Significance reduction in clinical symptom assessed by using WaLIDD score.6 Months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

NATIONAL INSTITUTE OF SIDDHA

🇮🇳

Kancheepuram, TAMIL NADU, India

NATIONAL INSTITUTE OF SIDDHA
🇮🇳Kancheepuram, TAMIL NADU, India
Dr Megganah S S
Principal investigator
6381372797
drmegumd@gmail.com

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