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

A study on the safety, spasmolytic and possible endocrinological modulatory effects of siddha Herbo-mineral formulations NIS KM and NIS KLM in primary dysmenorrhoeic (Dhoora soolai) state â?? A Preclinical and clinical approach

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/09/004974

Enrollment

Registered

2014-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIS KM: The drug NIS KM will be administered at a dosage of 2.5 gm two times/ day for first seven days of a menstrual cycle and for three consecutive cycles. Intervention2: NIS KLM: The

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

India

Contacts

Public ContactG J CHRISTIAN

NATIONAL INSTITUTE OF SIDDHA

christianvijila@gmail.com9962545930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026