Clinical research of Siddha medicine in primary dysmenorrhoea (Dhoora soolai)

Phase 2

Completed

• Conditions: Health Condition 1: null- primary dysmenorrhoea (Dhoora soolai)

• Registration Number: CTRI/2014/09/004974
• Lead Sponsor: ATIONAL INSTITUTE OF SIDDHA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

•Complaints of spasmodic dysmenorrhoeal pain almost every month

•Functional pain scale 3-5

•Age 18-27 years

•Patient willing to under go ultrasound abdomen and blood investigations

•Patient willing to sign the informed consent stating that she will conscientiously stick

To the treatment during the consecutive periods but can opt out of trial of her own conscious discretion.

Exclusion Criteria

•Patient with chance/ planning for pregnancy in the next one year

•Patient with history of dysmenorrhoeal pain commencing earlier than 4 hours from the onset of menstruation and lasting for more than 2 days

•Dysfunctional uterine bleeding

•Presence of any associated severe systemic illness

•Abdominal pain present other than the period of menstruation

•History of tolerable pain (Pain score 1-2) menstrual pain for three or more months altogether in the last 12 months

•Dysmenorrhoea three or more years after menarche

•Presence of any pelvic pathology as found out by Ultrasonogram

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GOOD -Reduction in Pain score to no pain or easily tolerable level 5-3 to 0-1 <br/ ><br>MODERATE- Reduction in pain score to just tolerable level 5-3 to 2 <br/ ><br>MILD Reduction in score but not below intolerable level 5-4 to 4-3 <br/ ><br>POOR/NIL - No reduction in pain score number or clearance of associated symptoms <br/ ><br> <br/ ><br> <br/ ><br>The terms Good and Moderate are considered as IMPROVEMENT <br/ ><br> Mild & Poor/Nil as NO IMPROVEMENT <br/ ><br>Timepoint: PRE CLINICAL SCREENING AND AFTER TREATMENT

Secondary Outcome Measures

Name	Time	Method
â?¢Lasting of relief after the completion of treatment <br/ ><br>â?¢Correlation of treatmental improvement with variables like parity, marital status, age, change in hormonal levels etc. <br/ ><br>Timepoint: PRE CLINICAL SCREENING AND AFTER TREATMENT