A Clinical study to see the effect of a Unani drug in the patients of Polycystic Ovarian Syndrome.
- Conditions
- Health Condition 1: N74- Female pelvic inflammatory disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/09/057869
- Lead Sponsor
- SUMER Jamia Hamdard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Diagnosis of PCOS according to Rotterdam’s criteria fulfilling any two of the following
Menstrual Irregularities or oligo/anovulation
Hyperandrogenism (clinically or biochemically)
Polycystic appearance on Ultrasound.
Patient with no previous history of taking OCP (Oral Contraceptive Pills) or HRT (Hormonal Replacement Therapy) within 3 months.
Willingness to sign the informed consent, follow the protocol and participate in the clinical study voluntarily.
1. Patients with
a) Cardiovascular disease or elevated blood pressure above 160/90mmhg.
b) Diabetes type 1 or 2
c) Kidney, liver or heart disease.
d) Thyroid disease.
e) Alchoholism
f) Hormonal contraceptives.
g) Irregular menstrual bleeding other than PCOS.
h)Uterine synachiae, Terine fibroid, Endometriosis, Cervical carcinoma.
i) Severe drug reaction.
2. Pregnant and Lactating women.
3. Unwilling to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Menstrual cycle <br/ ><br>2. Ultrasound PelvisTimepoint: 1. Cycle duration flow <br/ ><br>2. number & size of cysts
- Secondary Outcome Measures
Name Time Method 1.Reduction in testosterone level. <br/ ><br>2.Change in luetenizing hormone. <br/ ><br>3. Change in Ratio of LH FSH. <br/ ><br>4. Cahnge in Ferryman galloway score. <br/ ><br>5. Change in Insulin levels. <br/ ><br>6. Improvement in Lipid profile.Timepoint: All above points are seen from baseline to 3 months.