A clinical trial on dysmenorrhea

Phase 2

Completed

• Conditions: pain present in the lower abdomen during mensturation

• Registration Number: CTRI/2018/02/012037
• Lead Sponsor: National institute of siddha

Brief Summary

it is an open clinical trial to evaluate the therapeutic efficacy of sotruppu chenduram internal medicine from the siddha text pulipaani vaithiyam 500.the treatment will be given for 3 days 4.2grams orally o.d with vellaipoondu thailam the lab investigations and clinical assessment will recorded periodically before and after treatment period.all the trial related data will be recordered in Case Report Form (CRF) for each patient seperately. At the end of trial all the data will be analysed statistically and the research reports will be published

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-20
• Study Completion: 2017-10-10
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Age between 11 to 25 years.
• Nulliparous women.
• Patient willing to Ultrasound abdomen and blood investigations.
• Spasmodic dysmenorrhoeal pain ranging from 4-10 according to Numerical Rating Pain Scale.
• Patient willing to sign the informed consent.

Exclusion Criteria

• Presence of any pelvic pathology such as Chronic pelvic infection, Pelvic endometriosis, Adenomyosis, Uterine fibroid, Endometrial Polyp, IUCD in utero.
• Presence of any associated severe systemic illness.
• Abdominal pain presenting other than the period of menstruation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant outcome - Reduction of lower abdominal pain from 4-10 to 0 in the pain scale	3-5 days of menstruation and premenstrual period
Good outcome - Reduction of pain from 7-10 to1 – 3	3-5 days of menstruation and premenstrual period
Moderate outcome - Reduction of pain from 4-6 to1 – 3 and from 7-10 to 4-6.	3-5 days of menstruation and premenstrual period

Secondary Outcome Measures

Name	Time	Method
Reduction in the menstrual pain in successive 3 cycles	3 months

Trial Locations

Locations (1)

National Institute of siddha; 🇮🇳 Chennai, TAMIL NADU, India

National Institute of siddha

🇮🇳Chennai, TAMIL NADU, India

DrAMAmala Hazel

Principal investigator

9940429202

dramalaaruldhas@gmail.com