Clinical Trial on Efficacy and Safety of Evakind Tablets an Ayurvedic option in women diagnosed with PCOS
- Conditions
- Health Condition 1: E282- Polycystic ovarian syndrome
- Registration Number
- CTRI/2020/11/029044
- Lead Sponsor
- IMS BH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Rotterdam Criteria
Two of the three following criteria are diagnostic of the condition, assuming other causes have been excluded:
•Polycystic Ovaries
•Oligo-ovulation or anovulation. Number of menstrual cycles in last 1 year ( <8/year).
•Clinical and/or biochemical signs of Hyperandrogenism (HA)
Signs of clinical HA:
•Sexual hair growth graded by modified Ferriman-Gallwey3 (mFG) Score >=6-8
•Global Acne Grading System4
•Androgenic alopecia
Biochemical Signs of HA:
•Total Testosterone
•Luteinizing Hormone (LH)
•Follicle Stimulating Hormone (FSH)
Investigational
Polycystic ovarian Morphology confirmation by Ultrasonography
•Presence of at least 12 follicles measuring 2 to 9 mm in the whole ovary.
•increased ovarian volume (greater than 10 cm3)
Age >40 years or patients with menopausal levels of FSH ( > 20mIU/mL)
Hyperprolactinemia (Serum prolactin >30 ng/mL)
Patients with known 21-hydroxyase deficiency5 (Serum 17-hydroxyprogesterone < 2ng/mL)
Patients with uncorrected Thyroid disease ( defined as TSH <0.2 mIU/mL or >5.5 mIU/mL)
Patients on oral contraceptives, depo progestins, or hormonal implants, GnRH agonists and antagonists, IUCD (intra uterine contraceptive device) or using barrier contraceptives.
Organic lesion of the reproductive tract if any:
1.Benign growth
2.Malignant growth
3.Extensive cervical erosion
4.Cervical polyps
5.Endometriosis
History of spontaneous abortion in last 3 months.
History of any of the following systemic disorders:
1.Diabetes mellitus type 1
2.Coronary artery disease
3.Hypertension
4.Renal disease
5.Hepatic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoints <br/ ><br>1.Clinical features of PCOS at the end of study <br/ ><br>2.Length and days of menstrual cycle <br/ ><br>3.Quantity of menstrual flow <br/ ><br>4.Hirsutism <br/ ><br>5.Acne <br/ ><br>6.Androgenic alopecia <br/ ><br>7.Anthropometric parameters at the end of study <br/ ><br>8.BMI <br/ ><br>9.WHR <br/ ><br>10.Ultra-sonography for the morphology of ovary at the end of study <br/ ><br>11. Level of hormones (Testosterone, LH, FSH) at the end of studyTimepoint: Visit 1, Day 0, baseline (Recruitment) <br/ ><br>Visit 2, Day 30±2 days (Assessment visit) <br/ ><br>Visit 3, Day 60±2 days (Assessment visit) <br/ ><br>Visit 4, Day 90±2 days (Assessment visit) <br/ ><br>Visit 5, Day 120±2 days (Assessment visit) <br/ ><br>Visit 6, Day 150±2 days (Assessment visit) <br/ ><br>Visit 7, Day 180±2 days (Assessment visit) <br/ ><br>Visit 8, Day 365±7days (Follow-up visit)
- Secondary Outcome Measures
Name Time Method 1.Restoration of spontaneous fertility in married women who wanted to be pregnant.Timepoint: Visit 8, Day 365±7days (Follow-up visit)