The effect of Mustadigana Kwatha orally and Palashakshara Yamaka Uttarbasti versus Dienogest in the management of Adenomyosis-An open label randomised controlled clinical trial

Adenomyosis is the presence of ectopic endometrial glands within underlying myometrium. It is frequently diagnosed in young and infertile women. This disease is associated with pain or Abnormal uterine bleeding or both.  This trial is to evaluate and compare the combined effect of Mustadigana kwatha orally along with Palashkshara yamaka uttarbasti  versus Dienogest in managing adenomyosis and improving the quality of life .The trial will be performed in two groups consisting of 25 patients in each group. One group will be given Ayurvedic Management and the second group will receive Dienogest (2mg BD) for 3 consecutive months. The inclusion criteria includes -symptomatic patients have pure or dominant adenomyosis concurrent with uterine fibroids or endometriosis through USG , married women between age group of 30-45 years, those who are fit for Intrauterine Uttarbasti. Whereas exclusion criteria involves the patient having fribroids and endometriotic cyst of more than 5cm in size and endometrial thickness more than 11mm , Hb less than 8gm/dl , any congenital abnormalities, pregnant and lactating women,  uncontrolled hypertension or hyperthyroidism or hypothyroidism , uncontrolled Diabetes Mellitus. The primary expected outcome is decrease in PBAC score and VAS pain score , whereas secondary expected outcome is reduction of uterine volume / size of uterus and myometrial cysts (if any) evidenced by USG.