AN OPEN LABEL PILOT CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF ILAVANGADHI CHOORANAM IN THE MANAGEMENT OF SOOTHAGA VAAYU - POLYCYSTIC OVARIAN SYNDROME

STUDY PROCEDURES:

Screening Visit (will be conducted on the first visit)

Eligibility Assessment:

Potential participants will undergo a thorough evaluation to confirm their eligibility based on inclusion and exclusion criteria. This includes a review of medical history, menstrual patterns, and symptoms related to PCOS.

Physical Examination:

A comprehensive physical examination will be conducted to assess signs of hyperandrogenism (e.g., hirsutism, acne) and to rule out other medical conditions.

Baseline Assessments:

Baseline measurements will be taken, including anthropometric measurements (e.g., weight, height, waist circumference), blood pressure, and baseline hormonal assessments (e.g., serum testosterone, LH: FSH ratio, serum prolactin), laboratory tests (e.g., liver function tests, Renal function tests, lipid profile)

Intervention Period:

Administration of Intervention:

Participants will receive the investigational drug for consecutive six menstrual cycles according to the study protocol. Detailed instructions on administration, dosage, frequency, and duration of treatment will be provided. Participants will be educated on the importance of adherence to the intervention regimen.

Compliance Monitoring:

Participants will be instructed to maintain a treatment diary to record medication intake and any deviations from the prescribed regimen. Compliance will be monitored through regular review of treatment diaries and participant self-reporting during follow-up visits.

Regular Follow-up Visits:

Participants will attend scheduled follow-up visits at monthly once to assess treatment response, monitor for adverse events, and provide ongoing support and counseling.

Follow-up Visits:

Assessment of Efficacy Outcomes:

During follow-up visits, efficacy outcomes will be evaluated, including menstrual regularity (e.g., cycle length, ovulation rate), and clinical symptoms (e.g., hirsutism score, acne severity). Standardized assessment tools and validated questionnaires may be utilized for symptom evaluation. Changes in hormonal profiles (e.g., serum testosterone levels, LH: FSH ratio, serum prolactin) will be assessed in the third, sixth, and ninth months.

Safety Monitoring:

Participants will undergo regular safety assessments, including monitoring for adverse events, laboratory tests (e.g., liver function tests, Renal function tests, lipid profile), and vital signs monitoring. Any adverse events or unexpected findings will be promptly reported and managed according to study protocols.Compliance Review:

Compliance with the intervention drug will be reviewed, and participants will be provided with reinforcement and counseling as needed to optimize adherence. End-of-Study Visit: (will be conducted on the ninth visit)

Final Assessment:

At the end-of-study visit, final assessments of study outcomes will be conducted. This includes a comprehensive evaluation of efficacy outcomes (by menstrual regularity, clinical symptoms, hormonal assessment), safety parameters (e.g., liver function tests, Renal function tests, lipid profile), and participant satisfaction with the intervention.

Adverse Event Reporting:

Participants will have the opportunity to report any adverse events experienced during the study period. Adverse events will be documented, evaluated, and reported per regulatory requirements.

Participant Feedback:

Participants will be invited to provide feedback on their study experience, including satisfaction with the intervention, study procedures, and overall participation.