Polycystic Ovary Syndrome (Soothaga Vaayu)
Conditions
Interventions
Study setting:
Gynecologic Clinic in Base Hospital, Balangoda. Sri Lanka.
Randomization:
The random number list and random allocation sequence will be generated by one of the colleagues of the re
Sponsors
Unit of Siddha Medicine, Faculty of Applied Science
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subfertile women between 20 to 45 years with PCOS. (Subfertility defined as - Inability to conceive after 1year of regular unprotected intercourse) 2. PCOS will be diagnosed according to the International Evidence-Based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2018. Monash University: Melbourne, Australia; Sonographic appearance of polycystic ovaries and one of the following criteria: Infrequent cycles (formerly referred to as oligomenorrhoea) or amenorrhoea; hyperandrogenism (clinical or laboratory). 3. Women who have been under any form of treatment (Allopathic or Siddha or Ayurvedic or Unani or Homeopathic or Traditional Chinese) for PCOS or subfertility within the three previous months will be recruited after three months (washout time) without taking any medication for PCOS or subfertility.
Exclusion criteria
Exclusion criteria: 1. Women with inherited disorders such as Cushing syndrome, hyperprolactinemia, untreated hypothyroidism, congenital adrenal hyperplasia, or with an androgen-secreting ovarian/adrenal tumour and those taking a corticosteroid, antiepileptic or antipsychotic drugs. 2. Women who are not suitable for pregnancy (Uncontrolled Diabetic Mellitus, Uncontrolled Hypertension, etc) and women with Body Mass Index >30. 3. Women with tubal factor infertility and women whose partners have azoospermia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ovulation - It will be confirmed by Serum Progesterone 20 nmol/L or more in the mid-luteal phase [Day 21st of the menstrual cycle (after treatment of the first to sixth menstrual cycle) Every month, until positive results are achieved or until six months after treatment.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Conception: confirmed by positive serum or urinary test of hCG [Every month, will measure the baseline and track progress until positive results are achieved or until six months after treatment.] The change in menstrual cyclicity from reported baseline infrequent cycles to normal cycles [Base line and after treatment of the first to sixth menstrual cycle] Reduction of Ferriman-Gallwey (FG) score from baseline to 2.25 nmol/l from baseline (considered partial response) taking into consideration the 90th centile and IQR of serum testosterone respectively, as reported by Wijeyaratne et al 2011 [Base line and after treatment of the first to sixth menstrual cycle] Reduction of insulin resistance as assessed by HOMA IR from baseline to below 1.7 (considered good response) or reduction from baseline to below 2.5 (considered partial response) [Base line and after treatment of the first to sixth menstrual cycle] | — |
Countries
Sri Lanka
Contacts
Public ContactVijitha Paheerathan
Senior Lecturer
Outcome results
None listed