A clinical trial to study the effects ofhingwadi tail matrabasti and mefenamic acid in patients with dysmenorrhea

Phase 3

Not yet recruiting

• Conditions: Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,

• Registration Number: CTRI/2023/07/055239
• Lead Sponsor: Datta Meghe Institute of Medical Science

Brief Summary

Dysmenorrhea defines as painful menstruation of sufficient magnitude so as to incapacitate day-to-day activities. Dysmenorrhea can be of two types, primary dysmenorrhea, secondary dysmenorrhea. Primary dysmenorrhea is defined as painful menstruation without any obvious pelvic pathology. Secondary dysmenorrhea is defined as painful menstruation associated with underlying pelvic pathology. Itis seen in 50 % of post-pubertal women during 18-25 years of age. However, 20% of women have severe primary dysmenorrhea needing treatment.

In classical Ayurveda, dysmenorrhea is referred to as *Kashtartava.**Kashtartava* is a broad term that refers to any and all troubles and illnesses that a woman may experience during or before menstruation. in classical Ayurveda text bhaishajya ratnavali, *Hingwadi*tail is described for the treatment of *kashtartava*. the classical drug will be compared with the efficacy of the standard drug mefenamic acid. Diagnosis will be done on the basis of the symptoms of kashtartava (primary spasmodic dysmenorrhea). Assessment will be done on the basis of improvement of the clinical features. Measurement of severity on VAS (visual analog scale). The VAS using a 10-cm line represented the continuum of the participant’s opinion of the degree of pain**.**Total 2 follow up will be taken. It will be after the 3 menstrual cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Patients diagnosed as primary spasmodic dysmenorrhoea.
• Patients complaining painful menstruation for first two days for two Consecutive cycles.
• Patients having regular menstrual cycles.

Exclusion Criteria

• 1.Patients with major systemic diseases.
• 2.Patients having congenital anomalies leading to dysmenorrhea.
• 3.Patients having any detectable organic pelvic pathology.
• 4.Patients on hormonal therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure: change in subjective	assess after 3 consecutive menstrual cycles
parameter like abdominal Pain during menstruation, waist-hip pain, Low backache, Duration of Pain, Nausea, Vomiting, fatigue, diarrhea, headache.	assess after 3 consecutive menstrual cycles

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure: change in	objective parameter VAS

Trial Locations

Locations (1)

Datta Meghe Institute of Medical Science; 🇮🇳 Wardha, MAHARASHTRA, India

Datta Meghe Institute of Medical Science

🇮🇳Wardha, MAHARASHTRA, India

Dr Priya Chawle

Principal investigator

7499577917

priyachawle1411@gmail.com