THE MANAGEMENT OF PRIMARY DYSMENORRHOEA (KASHTARTAVA) - A PROSPECTIVE MULTICENTRIC OPEN OBSERVATIONAL STUDY

Ota Sarada; Devi Kanchnara P; Kutty Madhavi P; Kumari Krishna; Kale Kiran V; Bhatnagar Anu; Ota Sushmita Priyadarshini; Tomar Rinku; Jain Seema; M N Subhashree; N Srikanth; Padhi M M; Dhiman K S

Ota Sarada Research Officer (Ayu.)(Scientist-2), CCRAS, New Delhi, India.
Devi Kanchnara P Research Officer (Ayu.) (Scientist-2), Dr. Achanta Lakshmipati Research Centre for Ayurveda, Tamil Nadu, India.
Kutty Madhavi P Research Officer (Ayu.) (Scientist-4) (Retd.), National Research Institute for Panchakarma, Cheruthuruthy, Kerala.
Kumari Krishna Research Officer (Ayu.) (Scientist-4), Ayurveda Regional Research Institute, Jammu, India.
Kale Kiran V Research Officer (Ayu.) (Scientist-3), Ayurveda Mental Health Research Institute, Nagpur, Maharashtra, India.
Bhatnagar Anu Research Officer (Ayu.) (Scientist-2), Ayurveda Central Research Institute, Jaipur, India.
Ota Sushmita Priyadarshini Research Officer (Ayu.), Ayurvedic Research Institute for Mother and Child Health Care, Kerala, India.
Tomar Rinku Research Officer (Ayu.), National Institute of Ayurvedic Pharmaceutical Research, Punjab, India.
Jain Seema Research Officer (Ayu.), Ayurveda Central Research Institute, New Delhi, India.
M N Subhashree Research Officer (Ayu.), National Ayurveda Dietetics Research Institute, Bangalore, Karnataka, India.
N Srikanth Assistant Director (Ayu.), CCRAS, New Delhi, India.
Padhi M M Deputy Director (Tech.), 13Director General, CCRAS, New Delhi, India.
Dhiman K S Director General, CCRAS, New Delhi, India.

Keywords: Primary Dysmenorrhoea, Kashtartava, Rajahpravartini Vati, Single arm - multicentric -prospective-observational study.

Abstract

Objective: To evaluate the clinical usefulness of Rajahpravartini vati in the management of primary dysmenorrhoea (Kashtartava) and changes in the quality of life of the subjects.

Study design: A multi-centric prospective single arm observational study.

Setting and participants: 359 subjects aged between 16 - 35 years suffering from painful menstruation at least for three consecutive regular menstrual cycles were included in the study.

Intervention: Rajahpravartini Vati a classical Ayurvedic formulation was administered 250 mg b.d. with lukewarm water for 90 days followed by subsequent 90 days without intervention.

Outcome measures: The management of menstrual pain assessing by 10 points Visual Analogue Scale and improvement in the quality of life using SF-36 (RAND) questionnaire.

Results: The mean VAS score of pain at baseline was 6.94±1.98, decreasing to 1.7±2.22 at 90^th day which further decreased and maintained to 1.24±1.9 up to 180^th day. Associated symptoms like nausea, vomiting, constipation, giddiness, breast tenderness, diarrhea, headache and fainting were completely relieved. The improvements of quality of life in 8 domains viz. pain, general health, physical functioning, social functioning, emotional wellbeing, energy/fatigue, limitation due to physical health and emotional problems at the end of 90^th day of intervention was also significant (p<0.001) in comparison to baseline. No adverse event occurred during the treatment period.

Conclusion: Rajahpravartini Vati has shown a positive role for the treatment of dysmenorrhoea and to improve the quality of life of the subjects.