Study on navauppu mezhugu in dysmenorrhoea

Recruiting

• Conditions: Lower abdominal pain or pelvic pain during menstrual cycleBackache

• Registration Number: CTRI/2017/06/008938
• Lead Sponsor: Ayothidas pandithar hospital

Brief Summary

Dysmenorrhoea meanspainful menstruation of sufficient magnitude so as to incapacitate day to dayactivities. These patients can be divided into two groups for understanding thepathogenesis of this distressing condition. Navauppu mezhugu a classical siddhamedicine in siddha vaithiya thirattu is indicated for soodhaga vayu inparticular. The investigator has interpreted this soodhaga vayu as to beDysmenorrhoea and it is supported by the fact that this formulation is beingused in clinical practice by many traditional physicians.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-09
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1. Lower abdominal or pelvic pain during menstrual cycle 2) Functional pain scale 3-5 3) Backache.

Exclusion Criteria

1. Any major systemic illness 2) Hypertension 3) Renal disorder 4) Malignant tumor 5) vulnerable group.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved pain score reduced from 5-3 to 0-2	1) Total period – 1 1/2 years or till the completion of the study whichever is earlier | 2) Recruitment for the study will be for 1 year. | 3) Treatment duration for each patient- 12 days/4 cycles | 4) Follow up period after drug treatment for each patient -2 months | 5) Data entry analysis – 2 months | 6) Report preparation and submission – 2months
No improvement pain score not reduced below 3	1) Total period – 1 1/2 years or till the completion of the study whichever is earlier | 2) Recruitment for the study will be for 1 year. | 3) Treatment duration for each patient- 12 days/4 cycles | 4) Follow up period after drug treatment for each patient -2 months | 5) Data entry analysis – 2 months | 6) Report preparation and submission – 2months

Secondary Outcome Measures

Name	Time	Method
Complete clearance or reduction of size of uterine fibroids adenomyosis endometriosis ovarian cyst including associated symptoms	No clinical improvement

Trial Locations

Locations (1)

NATIONAL INSTITUTE OF SIDDHA; 🇮🇳 Kancheepuram, TAMIL NADU, India

NATIONAL INSTITUTE OF SIDDHA

🇮🇳Kancheepuram, TAMIL NADU, India

SATHIYABAMA

Principal investigator

9489912041

dr.sathyabama27@gmail.com