An Analytical and Comparative Study Between Shatavari and Nirgundi in Anovulation and Endometrial Expression Profiling
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Based on Subjective and objective parameters and laboratory investigations
Study Overview
Brief Summary
Anovulation is the failure of the ovary to produce an ovum. Technically anovulation refers to the absence of ovulation; however, some women ovulate infrequently. Anovulation or ovulatory dysfunction is most common cause of infertility which is about 30-40%. as per FIGO and, it is also possible cause of PCOS (Poly Cystic Ovarian Syndrome) due to hormonal imbalance. Hormones i.e. LH, FSH, oestrogen, Progesterone, prolactin, AMH, TSH and hypothalamo-pituitary ovarian axis play an important role in a complex procedure of ovulation but any alteration or imbalance between all these may lead to anovulation. The clinical features of anovulation resemble with symptoms of ‘beejadushti’ i.e. beejopaghata (destruction of sperm or ovum) and pushpopaghata (destruction of menstrual blood or ovum). In Ayurvedic texts, the information related to anovulation is found in scattered form.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Married women Patients with 2 consecutive anovulatory cycles.
Exclusion Criteria
- •Unmarried patients Patient having like organic pelvic pathology, benign and malignant tumours (Vulval, vaginal, rectal, cervical, uterine, ovarian), PID, congenital anomalies of genital tract and different type of infections of genital tract.
- •Patient suffering from chronic systemic diseases like uncontrolled hypertension, uncontrolled diabetes or any disorders influencing the general physical health and ultimately influencing menses.
- •Patients using IUCD and OCPs or injectable contraceptives & others.
- •Patients diagnosed with venereal diseases like syphilis, Gonorrhoea, HIV, HBsAg etc.
- •Patient is on chemotherapy/radiotherapy for malignant condition of the breast or any other organ.
Outcomes
Primary Outcomes
Based on Subjective and objective parameters and laboratory investigations
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
A Subjective Criteria
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Characteristics of menstruation
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Intermenstrual period
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Duration of menstrual bleeding
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Amount of blood loss
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
B Objective criteria
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Size and maturity of follicles/ovulation
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Viscosity of cervical mucus
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Hormonal profile
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Progesterone (on D 8 & 21),
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum LH (midcycle daily)
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum FSH (D2/3)
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Estradiol (D2/3)
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Prolactin
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Testosterone
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum AMH
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Cortisol (morning 7-8 am)
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Biochemical characterization of endometrium.
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Applebaum’s Uterine Scoring System for Reproduction (USSR)
Time Frame: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Secondary Outcomes
- Ovulation will be observed in the patients of anovulatory cycle(3 follow ups will be done with medication at the regular interval of one month or duration & interval of her cycle & last follow up will be done without medication after 3rd cycle of uttara basti)
Investigators
Dr Powar Padmja Parashram
Banaras Hindu University