A study on Kalingadhy thailam and Inji chooranam for the management of Primary Dysmennorrhea

Phase 2

Recruiting

• Conditions: Sequelae of complication of pregnancy, childbirth, and the puerperium,

• Registration Number: CTRI/2021/04/032668
• Lead Sponsor: Central Council for Research in Siddha

Brief Summary

This is an Interventional study to evaluate and compare the efficacy of two Siddha formulations. Adolescence is the transitional period marked with the onset of menarche an important milestone which is often associated with problems of irregular menstruation, excessive bleeding and dysmenorrhea. Current evidence suggests that dysmenorrhea happen due to myometrial contraction resulting from secretion of prostaglandin during secretary phase of endometrium. Primary aim of the study is to evaluate and compare the efficacy of kalingadhy thailam and Inji choornam in reducing pain among women in Reproductive age group with primary dysmenorrhea. menstrual pain will be assessed using WaLLID tool. Secondary aim is to assess the safety and status of Hormones after the administration of Kalingadhy thailam and Inji choornam. Prostaglandin F2 alpha will be measured in both venous blood and Menstrual blood.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-17
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1 Trial participants who are at the age group of 18-35 years 2 Menstrual pain for more than 3 consecutive regular menstrual cycle without pelvic organ pathology 3 Complaints of primary dysmenorrhea from menarche or shortly after (6–24 months) menarche.
• 4 Regular menstrual cycle of 24 to 32 days 5 Severe dysmenorrhea with 8-12 score using WaLLID tool.

Exclusion Criteria

1 Study participants who have pelvic inflammatory diseases 2 Irregular menstrual cycle 3 Secondary dysmenorrhea associated with ovarian cyst, endometriosis and fibroid (excluded clinically and radio logically) 4 Pain abdomen associated with excessive BPV 5 Having oral contraceptive pills and IUCD (Intrauterine contraceptive pills) 6 Who are under the treatment of hormonal therapy 7 who are pregnant/planning to pregnant, Lactating mother.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measures will be evaluating and comparing the efficacy of kalingadhy thailam and Inchi choornam in reducing pain among women with Dhoora soolai (Primary Dysmennorhea) by using WaLLID tool	Baseline and 3rd day of every month of intervention and follow up | totally 6 months

Secondary Outcome Measures

Name	Time	Method
Measuring the status of hormones before and after the administration of trial drugs.	Measuring safety of the trial drug kalingadhy thailam

Trial Locations

Locations (1)

Siddha Central Research Institute Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Siddha Central Research Institute Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr P Sathiyarajeswaran

Principal investigator

9443579540

crisiddha@gmail.com