Evaluation the efficacy of Siddha medicine (Soothaga Mezhugu) for the treatment of Polycystic Ovarian Syndrome.

An Open label pilot clinical trial to evaluate the effectiveness of SoothagaMezhugu in the management of Soothaga Vaayu (Poly Cystic Ovarian Syndrome) - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068998

Enrollment

Registered

2024-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Soothaga Mezhugu: orally twice at a dose of 200 mg with 5ml of Sombu theeneer during the first five days of the menstrual cycle for consecutive six cycles Control Intervention1: Nil: Ni

Eligibility

Inclusion criteria

Inclusion criteria: Participants must meet the diagnostic criteria for Polycystic Ovary Syndrome (PCOS) as per Rotterdam criteria. Women of reproductive age, typically between 18 to 35 years old, should be included. Non-pregnant participants or those not actively seeking pregnancy should be included. Participants must demonstrate willingness and ability to comply with study requirements, including attending study visits, adhering to treatment protocols, and providing informed consent.

Exclusion criteria

Exclusion criteria: Pregnant women or those actively trying to conceive. Women who have reached menopause or are in the perimenopausal period. Hypothyroidism patients. Participants with significant medical conditions (e.g., uncontrolled diabetes, cardiovascular disease, severe liver or kidney dysfunction). Participants currently using hormonal medications such as oral contraceptives, hormonal replacement therapy, or anti-androgenic medications should be excluded. Participants with a history of ovarian surgery. Participants currently enrolled in other clinical trials. Individuals lacking the capacity to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Preliminary efficacy outcomes will be carried by changes in hormonal profiles, menstrual regularity, decrese in Ovarian volume and clinical symptoms (e.g., hirsutism score, acne severity). Safety outcomes will be carried by Incidence of adverse events, laboratory abnormalities, and tolerability of Soothaga Mezhugu. This pilot clinical trial aims to provide valuable insights into the feasibility and potential efficacy of Soothaga Mezhugu for the management of PCOS.Timepoint: Baseline assessment - 0th day Follow up with interventional drug -6 months Drugless follow up -3 months Outcome assessment on 3rd month, 6th month and 9th month	—

Measure

Time frame

Preliminary efficacy outcomes will be carried by changes in hormonal profiles, menstrual regularity, decrese in Ovarian volume and clinical symptoms (e.g., hirsutism score, acne severity). Safety outcomes will be carried by Incidence of adverse events, laboratory abnormalities, and tolerability of Soothaga Mezhugu. This pilot clinical trial aims to provide valuable insights into the feasibility and potential efficacy of Soothaga Mezhugu for the management of PCOS.Timepoint: Baseline assessment - 0th day Follow up with interventional drug -6 months Drugless follow up -3 months Outcome assessment on 3rd month, 6th month and 9th month

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactK Suresh

National Institute of Siddha

drsureshherbal@gmail.com9962571137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026