Evaluating a traditional Unani remedy for Polycystic Ovary Syndrome in women

Clinical study of Marz-i-Akyas-i-Khusya-al-Rahim (Polycystic Ovary Syndrome) with therapeutic evaluation of Irsa (Iris ensata Thunb) with Ma-ul-Asal in its management: An open label, Randomized, Standard Controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106280

Enrollment

Registered

2026-03-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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: Safuf of Irsa with Ma ul Asal: It is a Classical Unani Formulation taken from Kitab Al-Hawi comprising of 7gm of Powder of Irsa (Iris ensata Thunb) given with 105 gm of Ma ul Asal (Hon

Eligibility

Inclusion criteria

Inclusion criteria: 1. patients diagnosed with PCOS by Rotterdam criteria 2. Menstrual disturbances like Oligomenorrhea and Secondary Amenorrrhea 3. Clinical or Biochemical evidence of Hyperandrogenism using modified Ferriman and Gallwey score or raised serum testosterone 4. USG finding of polycystic ovaries with more than 20 FNOP or ovarian volume of more than 10 ml in either ovary 4. BMI under 35 kg per m2 5. Patients who agree to sign informed consent and are willing to follow up as per the study protocol

Exclusion criteria

Exclusion criteria: 1. Pregnant and Lactating women 2. Patients with history of significant Systemic Illnesses including Cardiovascular, Hepatic or Renal disorders 3. Known cases of Type 2 Diabetes Mellitus, Uncontrolled Hypertension, Cushings syndrome, Hyperprolactinemia, Hypothyroidism and other Androgenic disorders like Adrenal hyperplasia or Androgen producing tumors etc. 4. Patients on Oral Contraceptives, spironolactone or other anti androgen drugs 5. Previous Surgery on one or both Ovaries 6. Patients having laser hair removal within the past 3 months 7. Patients not willing to attend the treatment schedule regularly

Design outcomes

Primary

Measure	Time frame
Change in menstrual cyclicity assessed using interval between cyclesTimepoint: 3 months	—

Secondary

Measure	Time frame
Change in Hirsutism assessed using modified Ferriman and Gallwey scoreTimepoint: At baseline and each follow up;Change in BMITimepoint: At baseline and each follow up;Waist Hip ratioTimepoint: At baseline and each follow up;Change in Ultrasonographic ovarian morphologyTimepoint: Baseline and end of study;Change in hormone profile including serum LH, FSH, LH FSH ratio and serum testosteroneTimepoint: Baseline and end of Study;Change in lipid profile including Serum Cholesterol, LDL, HDL, Triglycerides and VLDLTimepoint: Baseline and end of study;Blood sugar fasting and post prandialTimepoint: Baseline and end of study	—

Measure

Time frame

Change in Hirsutism assessed using modified Ferriman and Gallwey scoreTimepoint: At baseline and each follow up;Change in BMITimepoint: At baseline and each follow up;Waist Hip ratioTimepoint: At baseline and each follow up;Change in Ultrasonographic ovarian morphologyTimepoint: Baseline and end of study;Change in hormone profile including serum LH, FSH, LH FSH ratio and serum testosteroneTimepoint: Baseline and end of Study;Change in lipid profile including Serum Cholesterol, LDL, HDL, Triglycerides and VLDLTimepoint: Baseline and end of study;Blood sugar fasting and post prandialTimepoint: Baseline and end of study

—

Countries

India

Contacts

Public ContactDr Sana Bila Suhail

Regional Research Institute of Unani Medicine (RRIUM), Srinagar

shameem.rather.sr@gmail.com7889584083

Outcome results

None listed

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