An open label randomised controlled clinical study to evaluate the effect of An Ayurvedic Indigenous Drug Compound and Norethisterone tablet in induction of menstruation.

The absence of  menstruation is called amenorrhea, it can classified as physiological and pathological amenorrhea. Physiological amenorrhea like wise in pregnancy, lactation and menopause . Pathological amenorrhea is  due to pathology in endocrine or the uterine-ovarian axis. Pathological amenorrhea  is  commonly seen in day to day OPD’s with prevalence rate of 3 to 4% world wide and 21.3% in India. Ayurveda is a science that focuses on the quality of living, aims not only in curing the disease rehabilitating but also in preventing it. In the present scenario, the pathological amenorrhea is one of the gynecological issues which affects the quality of life of a woman and has a wider impact on her physical, psychological and social well-being. In Ayurveda classics the word ’Artava’ denotes two meanings one of them is Antah Pushpa and another one is Bahir Pushpa. Both are interrelated. Bahir Pushpa is outward manifestation of appropriate work of Antah Pushpa which is neccesory for conception. Here, the present study deals with Bahir Pushpa that is Menstrual blood. The word Artava is also used in our Sastras in various contexts to refer (Dhatu upadhatu roopa artava) hormones, (Beejaroopa artava) ovum and (rajas) menstrual blood.  Acharyas have mentioned various terms for absence of Artava i.e Nashtartava by Sushruta, Anartava by Vagbhata, absence of Raja by Bhela & Rajonasha by Bhavaprakasha.

In Ayurveda, Anarthava as a symptom is taken up as temporary imbalance of the presiding factors like Doshadushtilakshana, or as a symptom of a disease Vyadhilakshana. The pathophysiology of Anartava can be understood as there is no proper formation of artava or their will be kapha and vata obstructs the passage or orifices of channels carrying artava (artava vaha srotas), thus there will be no menstrual discharge. Since the Sushruta told, the treatment of anartava is directly mentioned as kaphavatahara and pittavardaka dravyas as like "Artava shonitam tu agneyam“. Vagbhata says "pittalai upacharet pravartamanam“

So as per references we have planned to  administer pittavardaka(agneya) dravyas for induction of             menstruation i.e artavajanana or artava pravatana or rajapravrutti.

Now a days the prevalence rate of amenorrhea is increasing day by day may due to unhealthy foods and lifestyle or some other causes. And women seeking treatment like hormone replacement therapy. In contemporary science progestins are widely used to alter (to induce/to stop) menstruation which are having its own adverce drug  reaction like breast discomfort, muscle ache, abnormal vaginal discharge and so on. As of now there is no ayurvedic formulation practiced for symptomatic treatment in amenorrhea. Hence there is need for the safe, potent and effective drug for induction of menstruation. So it will be a great boon to the women if it can be replaced by natural remedies with no side effects.

A pilot study was conducted on 8 subjects with history amenorrhea. Out of 8 subjects 4 attained menstruation with in 15 days and 2 subjects reported  as feeling of menstrual symptoms like heaviness of abdomen,whitedischarge per vagina  but bleeding not appreciated.2 subjects remained unchanged. About 40% of the patients required only less than 10 days for induction of menstruation with the medicine, 10% required upto 15  days and 50% no induction of menstruation seen.

So need to conduct the study in increased sample size and to know the effectiveness of an Ayurveda indigenous drug compound in induction of menstruation.