Role of Daruharidra Vati and Nishamalaki Vati in Polycystic Ovarian Syndrome

A randomised open-labelled comparative clinical study to evaluate the efficacy of daruharidra vati with nishamalaki vati in the management of PCOS with respect to insulin resistance - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106310

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: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects between the age group of after completing 18 years of age and below 45 years of age irrespective of Marital Status. 2.Subjects with irregular cycles and regular cycles. 3.Subjects willing to sign the consent form. 4.Subjects diagnosed with PCOS and Insulin Resistance.

Exclusion criteria

Exclusion criteria: 1.Subject with Primary amenorrhea, Congenital anomalies and Structural anatomical abnormalities like cryptomenorrhea. 2.Subjects on Insulin therapy and Oral hypoglycemic drugs. 3.Subjects on Oral Contraceptive Pills and Intra Uterine Contraceptive Devices. 4.Subjects with known case of Uncontrolled Chronic Systemic Illness and known case of malignancy. 5.Subjects who are Lactating and Pregnant.

Design outcomes

Primary

Measure	Time frame
1.Significant decrease in subjective and objective parameters of PCOS w.r.t Insulin resistance based on assessment criteria. a.Acanthosis Nigricans. b.Duration of flow in days. c.Interval between 2 cycles. d.Hirsutism. e.Acne. f.Alopecia. g.Skin tags. h.Central obesity. i. Waist circumference. j. FBS. k. OGTT. l. HbA1c. 2.The Efficacy of Daruharidra vati and Nishamalaki vati in PCOS w.r.t Insulin resistancce will be assessed based on assessment criteria aboveTimepoint: 0th, 30th, 60th, 90th day	—

Measure

Time frame

1.Significant decrease in subjective and objective parameters of PCOS w.r.t Insulin resistance based on assessment criteria. a.Acanthosis Nigricans. b.Duration of flow in days. c.Interval between 2 cycles. d.Hirsutism. e.Acne. f.Alopecia. g.Skin tags. h.Central obesity. i. Waist circumference. j. FBS. k. OGTT. l. HbA1c. 2.The Efficacy of Daruharidra vati and Nishamalaki vati in PCOS w.r.t Insulin resistancce will be assessed based on assessment criteria aboveTimepoint: 0th, 30th, 60th, 90th day

—

Secondary

Measure	Time frame
1.Generation of in-depth analysed data on the different aspect of the diseases. 2.Generation of data on possible unexpected drug reaction.Timepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Singapure Shraddha

Sri Sri College of Ayurvedic Science and Resaearch Hospital

shrutivinsun@gmail.com9886269111

Outcome results